Biocon India is focussing on recombinant therapeutics and biologicals. The company, which has initiated projects on these strategic lines, is all set to launch the first batch of products next year.

Kiran Mazumdar Shaw, chairman and managing director, told Pharmabiz.com that the first set of products, which includes a human insulin developed through a joint venture with Shantha Biotech, streptokinase, GCSF and EPO, are slated for a launch in 2003-2004.

Another new drug on the cards is an anti-cancer monoclonal antibody product for head and neck, which will be launched in 2005 as a new biological entity. Human clinical trials for this NBE in India are scheduled for late 2003, Mazumdar Shaw said.

Biocon's historical enzymes business continues to be a profitable for the company where it enjoys global leadership in select market segments viz. Pectinases, Tea Tannases and speciality Hemicellulases. However, this business accounts for only 25 per cent of the total business.

The company is perceived as a biopharmaceutical company with a strong capability base in statins and immunosuppresants. It continues to be the only Indian company to have FDA approval for Lovastatin and is scheduled for an FDA audit for Simvastatin and Pravastatin by the end of 2002.

Biocon's Mycophenolate mofetil for organ transplant is also gaining significant market share in India and in Latin American markets. Sales from this product in the current fiscal year are expected to be in excess of $3 million. The company's patent in Mycophenolate mofetil is a unique process involving bio-transformation in the esterification step - a strength that it derives from its enzyme knowledge base. Infact the company's fastest growing products are statins and Mycophenolate mofetil.

The two subsidiaries of Biocon India Group- Syngene and Clinigene continue to enrol new customers for its contract research business apart from building on its existing customers. While Clinigene is one of the three labs in India to be inspected by CAP and is expected to receive formal accreditation shortly. Clinigene's unique registries in diabetes and lipedemia are beginning to generate interesting medical leads in diabetes and cardiac segments. Its recent tie-up with Strand Genomics is also expected to lead to interesting discoveries.

On the investments in R&D, Shaw said that most of it was to support its foray into biologicals viz. recombinant technologies and monoclonal antibodies and animal cell culture. The Human Insulin project alone had necessitated substantial investment in both R&D and manufacturing.

In the area of exports and domestic market sales the current ratio stands at 50:50 but is expected to tilt in favour of exports in the coming year. The domestic market has shown tremendous volume growth but in revenue terms the growth is not commensurate because of price erosion, she pointed out.

The current year turnover of the company is estimated at Rs. 250 crore, which has shown a 25 per cent increase over the previous year. On the inherent strengths of Biocon, Shaw said it is the team's effort to speed up the commercialisation of the R&D work and the best technology for fermentation, commitment towards introducing new products into market each year, focus on quality and ability to conform to international standards.

Currently the company ranks third largest in terms of number of PCT patents filed in the country following Ranbaxy and Dr. Reddy's Laboratory.