Business

Biocon and Shanta JV for human insulin

By Our Special Correspondent

BANGALORE APRIL 10. A momentous development in the nascent Indian biotech industry has taken place with two of the pioneers, the Bangalore-based Biocon Indian Group and the Hyderabad-based Shanta Biotechnics forming a JV, Bicon-Shanta Biotech Ltd. to make and market recombinant human insulin. Human insulin today is imported into India and has a 50 per cent share of the total Rs. 150 crore domestic insulin market. The other half is accounted for by animal insulin (Bovine and Porcine).

The international patent granted to recombinant human insulin as a biopharmaceutical molecule is held by Eli Lilly and Nova Nortis and expires in January 2003. Their product is based on a bacterial organism. Shantha initiated work on developing the product three years ago, using a yeast organism (Pichia pastoris), licensed from RCT of Arizona and has successfully developed a cell line for insulin.

According to Varaprasad Reddy, Managing Director of Shantha Biotechnics, the pre-clinical studies have been completed, the regulatory clearance from the recombinant products authority is expected next week and clinical trials should be over in the next six months.

The joint venture is initially expected to have a capacity of 18 million doses per year of 40 strength and 3 million doses per year of 100 strength. Kiran Mazumdar, CMD of Biocon India Ltd., indicated that an additional investment of Rs. 25 crores will be made by the two companies to achieve this capacity.

Although human insulin is now preferred in the developed countries (especially after the Mad Cow scare), in India animal insulin still gets used because today it costs one-third the price of imported human insulin. There is also a lack of awareness about recombinant human insulin in the smaller cities.

By using a combination of lower pricing for human insulin, a new drug delivery system that does away with the needle (being developed by Biocon) and extensive market propogation, the new JV hopes to shift a greater part of the Indian insulin market to recombinant human insulin. Mr. Reddy also expects that the size of the market will expand several fold to Rs. 1,000 crores in the next few years. Export is also on the cards since after patent expiry next year, the world market opens up for recombinant human insulin as a biogeneric.

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