Biocon, Asia’s leading biopharmaceutical enterprise, released preliminary data from a recently concluded clinical study conducted in India, on IN-105, its novel oral insulin candidate for the treatment of diabetes.

Initial data analyses show that IN-105 did not meet its primary endpoint of lowering HbA1c levels by 0.7 percent as compared to placebo although an unexpectedly high placebo response was also observed. Post hoc analysis of self monitored blood glucose levels in the IN-105 arm and the placebo arm indicated large reductions in pre-meal glucose levels in the placebo arm strongly suggestive of behavioral modification, and which might have confounded the primary endpoint outcome.

Additionally, in further post hoc analyses, significant reductions in HbA1c levels as compared to placebo, and HbA1c reductions of up to 0.8 percent were observed in the IN-105 arm of several subsets of the studied patient population. Further assessment of the data is on-going.

Dr Kiran Mazumdar-Shaw, CMD of Biocon, said, “Based on these encouraging results, Biocon is committed to continue its global development of IN-105 in partnership with a global pharmaceutical partner for which we plan to initiate partnering discussions.”

On secondary safety endpoints, IN-105 demonstrated an excellent overall safety profile with no incidence of serious adverse events, and no occurrences of clinical hypoglycaemia. Data also shows that the drug is weight neutral and non-immunogenic.



Monsanto announces nine new projects
Monsanto, a global bioagri company that provides solutions and agricultural products, announced several projects across platforms, and crops designed to improve farmers’ on-farm productivity and profitability as part of its annual pipeline update.

The company announced key projects and insisted on pipeline collaboration with Germany-based BASF Plant Science, which was expanded to include wheat. Yield and stress projects advancing phases this year include nitrogen-utilization corn, second-generation higher-yielding soybeans and higher-yielding/stress tolerant wheat.

Following last year’s record-breaking 11 project advancements, this year’s nine advances are testament to the depth of the company’s R&D pipeline. Additionally, four of the advancements are new projects that were added to the pipeline, demonstrating that discovery work brings new opportunities.

ICMR plays down fears on congo fever
After a first ever case of human infection with Crimean Congo Hemorrhagic Fever (CCHF) virus being reported from Ahmedabad, Indian Council for Medical Research (ICMR), an apex body for the formulation, coordination and promotion of biomedical research in India has assured that CCHF outbreaks can easily be controlled by proper hygiene and infection control measures in the hospitals where patients are admitted.

Earlier the tests conducted at National Institute of Virology (NIV), Pune, confirmed the presence of CCHF virus in blood as well as urine samples of a patient. The CCHF virus is known to be transmitted among animals through ticks. There is serological evidence of CCHF infection being present in India in animals which however do not get the disease. It does not produce disease in animals but kills 20-40 percent of human beings who get the disease. So far, a team of doctors and technicians surveying six villages within a radius of five kilometers of Kolat which is about 40 kms from Ahmedabad in Gujarat detected 78 persons with symptoms of the viral fever.

CCHF is a viral haemorrhagic fever of the Nairovirus group. The disease was first described in the Crimean in 1944 and given the name Crimean haemorrhagic fever. The disease is endemic in many countries in Africa, Europe and Asia, and in 2001, cases or outbreaks have been recorded in Kosovo, Albania, Iran, Pakistan, and South Africa.

Qteros, Praj sign marketing deal
Qteros, the US-based developer of a unique and highly-efficient consolidated bioprocessing (CBP) platform for the low-cost production of cellulosic ethanol, and Praj Industries, a leader in the development of innovative technology and engineering solutions for the production of biofuels and biochemicals based in India, have announced a strategic partnership to accelerate commercialization efforts for industrial-scale cellulosic ethanol production.

The agreement leverages both Qteros’ broadly patent protected and highly-flexible CBP platform with Praj’s research capabilities and its technology, process design, engineering and construction expertise to deliver fully-integrated engineering design packages for the low-cost production of ethanol from a broad variety of non-food based feedstocks.

Qteros and Praj will collaborate on a highly-focused, multi-year development program with the objective of rapidly developing and commercializing process design packages (PDPs) that enable cellulosic ethanol production using Qteros’ Q Microbe-enabled CBP platform and Praj’s technology and expertise in the conversion of biomass to ethanol.

This unique licensing model serves to provide both a highly-efficient and low-cost solution to the market, while also allowing Qteros and Praj to deploy their capital in an efficient and leveraged manner. Importantly, the companies plan to retrofit Praj’s existing pilot plant in Pune with Qteros’ technology platform, which will then become the foundation for accelerated production scaling as part of its commercial planning.

Zero swine flu causality in 2011
With the number of reported deaths being nil out of the 10 laboratory confirmed cases during the first week of 2011, the year has started on good note on the swine flu casualities. According to the Indian Health Ministry’s statewise data of influenza H1N1, for the week ending January 9, 2011, the total 10 death cases were reported from different parts of the country. The four cases were reported from Tamil Nadu and one each from New Delhi, Maharashtra, Kerala, Karnataka, Punjab and Gujarat. Out of that, not a single death has been reported so far.

The lab confirmed cases since May 2009 stood at  46,152. Out of that, the total confirmed death cases were numbered 2,728. Again, since May 2010, the total number of the lab confirmed cases that were reported stood at 3,282. Out of that, the reported number of deaths were 246.

Besides the efforts made by Indian Health Ministry, the international agencies also played a good role in tackling swine flu. The World Health Organization  (WHO) provided the financial assistance amounting to about $533,000 (2.43 crore) besides the technical guidance from time to time to conduct district level training for rapid response teams. UNICEF, another UN agency, supported the Indian government in developing information, education, communication (IEC) materials for print and audio-visual media and for field publicity.

FBAE completes a decade of activity
The Foundation for Biotechnology Awareness and Education (FBAE), a non-profit, grass root society formed to support sustainable development through biotechnology awareness and education in India successfully completed a decade in science-based activity. With academicians, scientists and researchers as members, it was formed to bring together the global scientific community in 2001.Inaugurated by Prof. G Padmanabhan, former director, Indian Institute of Science, Bangalore, and presided over by Dr S Shantharam, the FBAE has since then actively conducted and participated in various workshops and seminars all over the country.

The foundation creates scientific awareness about modern biotechnology and educate the public and stakeholders about the perceived and potential risks and benefits of this emerging technology.

Qiagen opens subsidiary in India
Netherlands-based biotech company, Qiagen has formed an India subsidiary, Qiagen India, and has started direct sales in the country. Until now, Qiagen products have been sold in India through distributor partnerships. Qiagen has been active in India since 1995 and has developed numerous initiatives, partnerships and a strong network. The company expects that this enhanced presence will further contribute to its position in the market. The new office in New Delhi is an initiative to expand Qiagen’s footprint in emerging regions.

Nixon Biotech develops anti-HIV formulation
Nixon Biotech, an Indian biotech company, has developed a herbal mineral immunity enhancer for HIV/AIDS to inactivate the virus without any toxic effect on the body. If it proves its safety and effectiveness without any side-effects and gets green signal from the regulators in India, then this will be the first anti-HIV Ayurvedic formulation in the world to tackle AIDS. Currently, the anti-HIV formulation is being availed by the patients who are being treated at its campus. However, the company is yet to have the manufacturer’s license and has applied for the same.

Nixon Biotech is an ayurvedic pharma company that has been working on the natural AIDS immunity enhancer. The company started working on the project since 2005.

According to the company, the blend of minerals, antioxidants and herbs are combined and optimized to give the body the essential nutrients required for improving general condition and overcoming weakness. This natural formulated medicine helps in promoting the protein and carbohydrates in the metabolism of body.

Mr Ravi Goel, chairman of Nixon Biotech said, “The dosages for the patients are recommended in form of IC-50 and IC-80. While the IC-50 reduces the virus by 73-95 percent, the IC-80 completely wipes out the virus.”

Hilleman Lab project to assess vaccine formulation

The MSD Wellcome Trust Hilleman Laboratories has announced its frist project, it will be a feasibility study into how new technologies might be used to develop a rotavirus vaccine designed specifically with developing country needs in mind. Formulations based on dissolving thin strips or granules will be examined for their potential to improve product stability, transportation and affordability. The therapeutic focus of the project has been selected because of the tremendous global impact of rotavirus diarrhea on childhood mortality. If the initial study is successful, options to further develop the technology for rotavirus and other oral vaccines of importance to developing country health will be explored.

“Many first-generation vaccines have not been developed with the specific needs of countries with poor infrastructure for vaccine delivery in mind. This is a much needed exploration of how to tackle one of the greatest public health and logistics challenges in the developing world — distributing life-saving vaccines without the requirement for large bulk shipments, expensive warehousing and costly, difficult-to-maintain refrigerated shipping paths from the manufacturing plant to the patient,” said Dr Altaf A Lal, CEO, Hilleman Laboratories.

The project is a three-way collaboration between the Hilleman Laboratories, MSD and Medicine in Need.

Aurobindo Pharma announces strategic divestment

India-based Aurobindo Pharma Limited (APL) has entered into a definitive agreement with China National Pharmaceutical Group Corporation (Sinopharm) to divest in its subsidiary company Aurobindo (Datong) Bio Pharma, China (ADBPL), subject to regulatory approvals. Sinopharm will acquire the shares through its subsidiary company Sinopharm Weiqida Pharmaceutical.

ADBPL is engaged in manufacturing of 6APA, a derivative of Penicillin-G and most of its production is consumed by APL India. In past the performance of ADBPCL has been affected due to economies of scale and is incurring losses. After acquisition of 51 percent equity in ADBPL, the investors will further infuse capital to enhance its shareholding to 80.50 percent, reducing APL share in the JV to 19.5 percent. APL’s loan of $23 million to ADBPL will entirely be paid back.

Sinopharm group will infuse sufficient funds to relocate plant as required by local government in China and significantly enhance capacity and downstream products leading to better economies of scale and reduced cost of production. APL’s investment of 19.50 percent will be strategic in nature to ensure uninterrupted supply of raw materials at competitive price. Over the past six years, APL has undertaken a paradigm shift from API to formulations business. Hence, the board feels that the said divestment is in the best interest of the company.