GlaxoSmithKline to introduce Boostrix

GlaxoSmithKline has announced the forthcoming launch of the vaccine Boostrix comprising Acellular Pertussis reduced, Diphtheria Toxoid reduced and Tetanus Toxoid (dTpa) in India.

Announcing this at the Pedicon 2006 conference at New Delhi, Kalayanasundaram, managing director, GlaxoSmithKline India, said, "Boostrix is available in 32 countries globally with 2 million doses already distributed since 1999 and will now be available in India for all age groups over 4 years. Clinical studies for Boostrix demonstrate a superior safety and immunogenicity profile in children and adolescents."

Boostrix has been registered for use in children over the age of 4 years, who have already received their primary DTP doses in the first and second year of life. Currently Boostrix is the only globally approved acellular pertussis boosting vaccine for all age groups available in India. According to a Central Bureau of Health Intelligence (CBHI) study, the number of reported cases of pertussis in India has increased recently, by 50 percent from 1997 to 2003.

Dr Sanjoy Datta, director of clinical R&D and medical affairs of GSK Biologicals - South Asia said, "Older children and adults have been proven to be reservoirs for pertussis disease, thus acting as a source of infection to the unprotected (i.e. those who are too young to be immunized or have never taken the vaccine or booster doses). Pertussis in newborns can be fatal."

... launches Suraksha Kavach Program

GlaxoSmithKline has introduced the Suraksha Kavach Program that aims to create and cultivate the importance of protection and promote wellness in society. GlaxoSmithKline launched this unique social responsibility drive by participating and complementing the government's initiatives in recognizing the National Bravery Award winners.

On the eve of India's 56th Republic Day, GlaxoSmithKline, in association with the Indian Council for Child Welfare (ICCW), held a special ceremony to honour the exemplary courage of the children who were selected for this year's National Bravery Award. The children were each presented a citation, a 'Suraksha Kavach' trophy and a pledge to protect them with GlaxoSmithKline vaccines.

Speaking on the occasion, Dr Sanjoy K Datta, director - clinical R&D and medical affairs, GSK Biologicals - South Asia said, "We are extremely privileged to honour the achievements of these seventeen brave children. Their contribution is inspiring and their heroic deeds truly represent protection. They are ambassadors for the 'Suraksha Kavach' program, whose objective is to instill the importance of protection and wellness for individuals, families and society at large. Through these children, the program aims at creating, cultivating and rewarding the importance of protection in the society."

Dr Cormac Kilty (extreme left) and Kiran Mazumdar-Shaw shake hands after signing the MoU. Bertie Ahern (center) looks on.

Irish Bioindustry Association sign MoU with ABLE

IBEC's Irish BioIndustry Association (IBIA) has signed a memorandum of understanding with its Indian equivalent, the Association of Biotechnology Led Enterprises (ABLE), in an effort to improve collaboration between the biotech sectors in Ireland and India.

The agreement was signed at the headquarters of India's leading biotechnology company, Biocon in Bangalore. Dr Cormac Kilty, managing director of Dublin-based biotech company Biotrin and chair of the IBIA, signed on behalf of IBIA with Dr Kiran Mazumdar-Shaw, chairman and managing director of Biocon, Irish Honorary Council to India signing as President of ABLE. The signing was witnessed by Bertie Ahern Taoiseach and Minister for Enterprise, Trade and Employment, Micheál Martin TD as was a key part of the ongoing Irish Trade Mission being led by the Taoiseach.

This agreement, which is the first between the respective industries, lays the foundation for collaboration between the two fast growing sectors. Significantly, the agreement was signed soon after the news that the Indian biotech firms have posted combined revenues of over $1 billion for 2005, an increase of 36 percent on the previous year's figure. The new agreement is expected to open up potential partnerships in research and commercialization as well as sub-supply opportunities for Irish and Indian companies alike.

Cormac Kilty, chairman, IBIA, said, "I am very exited about what is happening here in India. It bears many similarities to the Irish experience. We are both fast growing economies looking to be leaders in modern industries such as biotech. I believe that we have much to learn from each other. I have no doubt that very tangible benefits will flow out of this agreement."

Kiran Mazumdar-Shaw, President - ABLE said, "My ties with Ireland go back several years and I am very pleased that ABLE and IBIA are coming together to synergise the biotech strengths of our respective countries. Biotechnology is a growing industry both in India and in Ireland and I am confident that with this agreement we have taken a step towards potential collaborations and knowledge sharing between our two countries."

Matt Moran, director, IBEC, said, "India is strong in pharmaceuticals - just like Ireland. It is trying to develop biotech just like Ireland as well. It makes a huge amount of sense to partner together and help each other to take the lead. It is now our intention to work actively with our Indian counterparts to achieve this aim. I look forward to a very productive relationship."

Ocimum ranks 55th in Deloitte Tech Fast 500 Asia-Pacific 2005

Ocimum Biosolutions, a Hyderabad-based life sciences R&D enabling company with competencies in BioIT, Microarrays and Contract Research Services, was ranked 55th amidst the 500 fastest growing technology companies of repute across the Asia-Pacific region by the world-renowned Deloitte Technology Fast 500 Asia-Pacific 2005 Program. The program recognizes public and private companies across the Asia Pacific regions that have achieved the fastest rates of annual revenue growth during the past three years.

According to an official press release, Ocimum also has the distinction of scoring 4th rank in the Deloitte Technology Fast 50 India 2005 Award, again a program based on a three year average percentage revenue growth which ranks the 50 fastest growing technology companies by geographic region. This Fast 50 program supplements the broader Deloitte Technology Fast 500 initiative in that the winners typically become automatically eligible to participate in the Fast 500. The awards are researched and sponsored by the Deloitte Technology, Media & Telecommunications (TMT) Industry Group.

Anuradha Acharya, CEO, Ocimum Biosolutions, said "We at Ocimum have just started on our growth track and this recognition by Deloitte is very encouraging for us as we look forward to attaining our desired results".

Strand and ChemAxon enter into collaboration

Strand Life Sciences, a premier in silico technologies innovation company focused on developing technologies for drug discovery and development has integrated ChemAxon's JChem suite of software with admetis, its tool for modeling and predicting drug-relevant properties of molecules in silico. The integrated offering will be launched in the early part of Q1 2006.

admetis is a comprehensive tool for modeling and predicting drug-relevant properties of molecules in silico. It gives users the power to build custom models using their own data. This is made possible through easy and intuitive model-building workflows based on Strand's expertise in in silico model building. admetis comes packaged with its pre-built models, truPK and truTox, for predicting bioavailability, protein binding, volume distribution, elimination half life, rate of absorption and hERG binding. admetis has an extensive data mining and visualization module that supports an embedded chemical structure viewer.

The inclusion of ChemAxon's JChem toolkit provides admetis with a feature rich, chemically aware data management and search framework. admetis users will be able to enjoy state of the art chemical editing and visualization capabilities as well as the power to build complex queries using structural and non structural data.

Strides signs pact with Clinton Foundation for HIV drugs

Strides Arcolab Ltd has signed an agreement with the Clinton Foundation to make available a range of affordable anti-retroviral drugs for the treatment of HIV/AIDS in countries that are under the aegis of the Clinton Foundation HIV/AIDS initiative.

Speaking at a formal ceremony at New York to announce the agreement, Arun Kumar, Group CEO and managing director, Strides Arcolab Ltd, said "We are committed to supply a comprehensive range of first line and second line anti-retroviral drugs that meet global quality standards at affordable prices."

Speaking on the occasion, Clinton said, "Strides Arcolab (India) will offer the ARV efavirenz for $240 per patient per year. This price represents savings of more than 30 percent from current market rates. Following this agreement, Strides will also supply first-line ARVs under Clinton Foundation agreements. Lowering the price of second-line drugs is a major priority for my Foundation in 2006. Treatment, once started, is a lifelong commitment, and over time patients move from low-price first-line drugs to second-line combinations that are at least 10 times more expensive. Keeping the global cost of AIDS treatment sustainable will only be possible if we lower the prices of these medicines."

Mukesh D Ambani, chairman and managing director, Reliance Industries Ltd, delivering the keynote address at the first of the Dhirubhai Ambani Life Sciences Symposia Series on "Preventive and Predictive Molecular Diagnostics". KV Subramaniam, senior executive vice president, Reliance Life Sciences, Dr NK Ganguly, director general, ICMR and Dr Dhananjaya Saranath, research director, Reliance Life Sciences look on.

"Future of molecular diagnostics is very bright and vastly stimulating"

"The world is moving from looking disease as a state to disease as a process – a process dependent on a person's genetic make-up, environment and life style. New methods of molecular diagnosis would help manage better a patient's disease. It would also help determine the pre-disposition of patients to diseases. Thus, the field of preventive and predictive molecular diagnostics promises to be very exciting. I have no doubt that the future of molecular diagnostics is very bright and vastly stimulating," said Mukesh Ambani, chairman and managing director, Reliance Industries Ltd.

Delivering the keynote address at the first Dhirubhai Ambani Life Sciences Symposium on Preventive and Predictive Molecular Diagnostics that was inaugurated by Dr NK Ganguly, director general, Indian Council of Medical Research, Ambani said, "The predictive and preventive molecular diagnostics would bring about an era of personalized medicine. It would bring with it enormous opportunities for scientific, technological, business and social development. For the diagnostics industry this represents an unprecedented opportunity for integration, increased value and commercial opportunities. Research-led companies would have the opportunity to work on new targets based on nucleotide polymorphisms and biomarkers."

Underlining the important complex issues that would come in the way of evolution of predictive and preventive molecular diagnostics in the larger realm of personalized medicine, he said, "Preventive and predictive molecular diagnostics would fundamentally change the way health care is delivered and managed. It would call for new partnerships – among scientists, technologists, clinical research professionals, educationists, investors, businessmen, physicians, medical insurers, regulators and sociologists."

He further said, "We at Reliance Life Sciences, believe we are lending a helping hand in the innovative, path breaking domain. It is a great chance to play a critical and lifesaving role in the realm of predictive medicine, a role that is unpredictable."

"The Dhirubhai Ambani Life Sciences Symposia Series is an endeavor to bring state-of-knowledge, contemporary developments and future trends in diverse domains within life sciences, for the benefit of scientists, academicians, clinical professionals, and industry participants. This symposium would be followed by our second symposium on stem cells, slated for February 27-28, 2006. It will showcase developments in the world of stem cells, including that of Reliance Life Sciences since stem cells has been the first initiative of Reliance Life Sciences," said KV Subramaniam, senior executive vice president, Reliance Life Sciences Ltd.

Asia's first life science portal launched

Asia's first exclusive portal dedicated to the life sciences industry, www.biospectrumasia.com, which provides comprehensive coverage of the exciting business developments in the region, has been launched.

"Through this portal, BioSpectrum, India's first and only exclusive biotechnology business magazine, will extend its footprint to cover the path breaking happenings in the Asia-Pacific region's life sciences," said Pradeep Gupta, chairman and managing director of CyberMedia (India) Ltd, the publisher of BioSpectrum.

As the world's economic fulcrum gradually shifts towards Asia, there is an increased focus on the exciting happenings in different industrial sectors. In the 21st century, life sciences has emerged as one of the most promising segments in terms of growth as well as providing benefits to a vast number of people in the world.

"In addition to the news-based website, the exciting developments in the life sciences sector in the world's fastest growing region will be delivered to industry leaders in all the Asia Pacific countries through a fortnightly digital magazine and a bi-monthly print magazine, under the brand name BioSpectrum from Singapore," added Shyam Malhotra, editor-in-chief, BioSpectrum.

The Asia edition of BioSpectrum will provide comprehensive coverage and useful insights into the exciting areas of pharmaceuticals, biotechnology, medical devices, and research highlights and policy announcements from around the world, which will be of use to the life sciences business leaders in the region.

Life sciences is the term used to refer to pharmaceuticals, biotechnology, medical devices and healthcare services. While Japan has always had a major presence in life sciences, including the world's second largest pharma industry, in recent years, China, India, Taiwan, Korea, Australia and Singapore have emerged as significant players in this arena.

The global life sciences industry is estimated to be worth about $2 trillion. The Asia-Pacific region accounts for nearly 20 percent of the sector even though it is home to nearly 60 percent of the world's population. But this region is fast catching up with double-digit growth rates. If healthcare services are excluded, the life sciences sector will be approximately $1 trillion. And the Asia-Pacific region has nearly quarter of the share of life sciences excluding healthcare

Transgene Biotek completes development of oral delivery of insulin

Transgene Biotek Ltd has completed the development of oral delivery of insulin and oral delivery of Hepatitis B vaccine in collaboration with the pharmacology division headed by Dr Prakash V Diwan at the Indian Institute of Chemical Technology, Hyderabad.

The pre-clinical trials on oral delivery of insulin and Hepatitis B have demonstrated exciting results. The drug is to be administered in liquid form as oral drops. Similarly, the pre-clinical trials on oral delivery of Hepatitis B vaccine have demonstrated the generation of anti-body titres to a single dose of oral delivery comparable to that of injectable Hepatitis B vaccine, according to information sent to BSE in December 2005.

The information says that Transgene Biotek is the first company in the world to have developed this technology to deliver Hepatitis B vaccine through oral route. Oral administration of this vaccine that provides the easiness in administering the vaccine to the infants and children, combining with cost reduction shall be a major factor in the disease control of this viral infection across the world.

With the pre-clinical trial data providing exciting results, the management is in discussions with one of the biggest pharma companies in the world to out-license the oral delivery of insulin as a first step and has also initiated steps to take it to the next stage of clinical trials in India and Europe simultaneously.

Biocon Q3 net dips 28%

Biocon Ltd reported a drop in net profit at Rs 44 crore for the third quarter ended December 31 against Rs 50 crore in the corresponding previous quarter. During the April-December period, earnings declined to Rs 126 crore from with Rs 155 crore a year ago, the company said in a statement. However, it added that Biocon's performance during the nine months was according to expectations with revenues touching Rs 578 crore.

Consolidated sales grew 7 per cent over the same period in the previous year, while operating profits dropped by 7 per cent. The profit after tax margin stood at 22 per cent, it added.

"The operating results continued to be challenged by difficult pricing environment in the European statins market. However, the US market for generic statins offered a respite in 2006-07," the statement said.

Research services and insulin and other pharmaceutical products posted a strong growth during the nine-month period. Biocon's discovery-led diabetes and oncology research programmes were making good progress, the company said.

Taking stock of the company's performance, Kiran Mazumdar-Shaw, chairman and managing director, said, "I am pleased that we continue to deliver healthy profits at a time when we are investing in our discovery-led research programs."

"Operating margins of 30 per cent demonstrate the quality and spread of our various businesses," she said. "We are excited over the progress being made on the research and development fronts as we believe that we are creating powerful innovation platforms for future," she added.

The company is building domain knowledge in both oncology and diabetes, which are focal points of its discovery-led research programs. The research, combined with manufacturing expertise, reinforced Biocon's integrated bio-pharmaceutical model, Mazumdar-Shaw said.

Biocon gets GEAC nod to carry out clinical trials

Biocon India Ltd has received green signal from the Genetic Engineering Approval Committee (GEAC) to conduct of clinical trials with r-Human Granulocyte Colony Stimulating Factor (rh GCSF) developed by it in India and scale–up of the product process for R&D purpose.

Biocon proposes to conduct open, multicenter study, to evaluate efficacy and safety of rh GCSF in patients with chemotherapy induced neutropenia. The total number of patients to be enrolled is around 50. According to reports the company has identified 7 centers for conduct of clinical trials.

Similarly Biocon has received the committee approval for conducting clinical trials with r-Streptokinase developed by it in India and scale-up of the product process for R&D purpose. The company proposes to conduct a randomized, comparative, multicenter study to evaluate efficacy and safety of r-Streptokinase in patients with acute myocardial infarcation. It is proposed to enroll about 60 patients at two centers namely department of Cardiology, St John's medical College hospital, Bangalore and Narayana Hrudayalaya Institute of Cardiac
Sciences, Bangalore.

The GEAC has also given its consent to Biocon to conduct large-scale process optimization studies (R& D purpose only) of oral insulin IN –105 precursor, for the production of oral formulation of recombinant human Insulin.

News Flash

Kapil Sibal elevated as cabinet minister

In the first major expansion of his 20-month old Council of Ministers, Prime Minister Manmohan Singh on January 29, 2006 inducted 19 new ministers and elevated three Ministers of State to the Cabinet level. Kapil Sibal, who was the Minister of State Minister for Science & Technology and Ocean Development (independent charge), has now been promoted to the Cabinet rank to give due representation to the national capital Delhi in the Union Cabinet. The elevation of a suave and erudite Kapil Sibal as Cabinet Minister assumes significance considering the fact that the Prime Minister is keen to promote science and technology in the country. Sibal has been playing a very important role in promoting science and technology and his elevation will help in speeding up the growth of science and technology in the country.

Sibal has been playing a key role in helping shape the future of biotechnology in the country. He initiated the debate on the National Biotech Policy and set the ball rolling with national biotech development framework. He has helped the industry by removing several hurdles, convinced the finance minister to grant concessions to the industry, and is now all set to introduce an India-specific Bayh-Dole like Act to spur innovations in research in academia. The industry is upbeat with Sibal's elevation as a Cabinet Minister.

Elections for ABLE Executive Council in February

The Association of Biotechnology Led Enterprises (ABLE) is holding the elections for its Executive Council on February 15. It has adopted for the first time an online election process. The nominations were filed from January 5, 2006 to January 31, 2006. These members of the Executive Council will then elect among themselves, the president, vice-president, general secretary and treasurer. The election is being conducted by the executive director of the society.

Sultanate of Oman Licenses LabVantage's Sapphire

LabVantage Solutions Pvt Ltd, a The Chatterjee Group Company, announced that the Sultanate of Oman has licensed its Sapphire Laboratory Information Management Solution (LIMS) for its regional environment and water resources laboratories. The Sultanate of Oman is one of the wealthiest countries per capita in the world, and as a fast growing nation is seeking to continuously improve the quality of its food, water, and other environmental resources.

"We selected Sapphire for its cutting edge technology, out-of-the-box functionality, vast flexibility, and significant ease of use," stated Dr Subhash Deshmukh, head, Laboratory Operations of Ministry of Regional Municipality of the Sultanate of Oman. "We are honored to have the Sultanate of Oman as one of LabVantage's leading customers in the Middle East," said Anil Kastuar, president, LabVantage's Asia Pacific operations. "We look forwarded to working with them as we continue to expand our business in the region and in Asia."

LabVantage will implement Sapphire across the Sultanate's environmental, food testing, microbiological, trace element analysis, and organic pollutants laboratories. With nine regional laboratories situated in different regions of Oman, the Sultanate will leverage Sapphire's thin-client technology for enterprise wide access and visibility. Moreover, LabVantage's Evergreen configuration tool will allow the Sultanate's users to tailor the same Sapphire solution to meet the unique needs of each of these laboratories while all running on one enterprise platform.