India's biotechnology majors, Biocon India Group and Hyderabad-based Shantha Biotechnics, have announced a joint venture, Biocon-Shantha Biotech Limited for the manufacture and marketing of Recombinant Human Insulin. The new product 'Pichiapastoris' is produced using yeast and will be the first of its kind in the country. Right now toxicity studies and clinical trials are on and the product is expected to hit the market in the next six months.

Biocon's expertise in fermentation technology together with Shantha Biotechnics strengths in regulatory frameworks gives a promising start to the new venture, which is a 50:50 equity partnership.

The investment for the production of Recombinant Human Insulin is to the tune of Rs. 25 crore. The total value of the Insulin market is Rs. 150 crore. Out of this the animal insulin share is 100 crore and human insulin is Rs. 50 crore.

The joint venture aims to maximise the R&D, manufacturing and regulatory capabilities of the two companies with a view to expeditiously bring recombinant human insulin into the Indian market.

Human insulin is rapidly replacing animal insulin (Bovine and Porcine) and already commands a market size in excess of $1 billion per annum. This trend is reflected in the Indian insulin market as well. Human Insulin today is an imported product and has 50 percent share of the total Rs. 150 crore insulin market in India. The joint venture hopes to shift a greater part of the insulin market to the recombinant Human Insulin segment as well as to expand the total insulin market in the country.

The diabetic segment is one of largest disease segments and is growing at the rate of 25 percent per annum. It is estimated that there are approximately 40 million diabetics in the country of which only 20 million are diagnosed. Of these two types of Diabetes, Type II is the more prevalent form in India, which represents 90 percent of the total diabetic population. Whilst Type I diabetics are totally insulin dependent, 80 percent Type II will require insulin therapy said Kiran Mazumdar-Shaw, chairman and managing director, Biocon India Group here this morning at a press briefing.

Shantha Biotechnics initiated work on the project three years ago and has successfully developed a cell line for insulin. Further technology development is being jointly pursued by the two companies and promises to be a globally competitive both in terms of quality and price. "Human insulin can now be produced cost-effectively and since the product development requires enormous scale-up, Biocon will pitch in its expertise and said Shaw.

The patent granted to recombinant Human Insulin as a bio-pharmaceutical product expires in January 2003 and opens up the world market for recombinant human insulin as a bio-generic. Currently the patent holders are Eli Lily and Novo Nordisk for the recombinant Human Insulin.

Both Shantha and Biocon are pioneering biotech companies. While Biocon has the distinction of being the first and largest biotech company in India and first Asian company to receive the US FDA approval for Lovastatin, Shantha Biotechnics is credited to be the first to introduce a recombinant product in to the Indian market (Hepatitis B vaccine) and has recently received the approval to introduce Alfa interferon 2b. "Human insulin has provided us an ideal platform to work on and as a globally competitive technology the partnerships of two biotech majors are vital, said Varaprasad Reddy, managing director, Shantha Biotechnics.

There will be a string of products in the pipeline under the joint venture.

Shantha which is known for its Shanvac B and Shanferon, is all set to produce Alpha Interferon GM-CSF, G-CSF, Streptokinase, tPA, EPO and Human Growth Hormone (hGH). It also plans production of Diagnostic kits-AlphaFeto Protein, Troponin I, Hepatitis B surface antigen, Hepatitis E and Hepatitis Cv. The company will also develop Vaccines for Hepatitis E, Typhoid, Tuberculosis and new generation vaccine against Hepatitis B, apart from Therapeutic antibodies like Lung carcinoma, Melanoma, Cardiovascular diseases and Anti-D, informed Reddy.

Biocon is known for its statins and the recent development of an organ transplant drug- 'Mycophenolatemofetil'. It is embarking on an very ambitious plan with a whole bunch of products which will include five recombinant proteins, Streptokinase TCg and monoclonal antibodies. The plant for the development of monoclonal antibodies will be ready in 2003 for which there has been an investment of Rs. 200 crore.