The Hindu Business Line : `Cancer drug, oral insulin programmes on track'

Ms Kiran Mazumdar Shaw, Chairman and Managing Director, Biocon Ltd, and Mr Ajay Bharadwaj, President, Marketing, arriving to address a press conference in Bangalore on Wednesday. — G.R.N. Somashekar

Bangalore , July 20

BIOCON on Wednesday said its partnering strategy was beginning to bear fruit.

Its discoveries for diabetes and cancer were progressing well and could develop into large global opportunities in the next 2-3 years, its CMD, Ms Kiran Mazumdar Shaw, said.

At least one monoclonal antibody for treating different types of cancer is set to hit the Indian market in the current or next fiscal.

As for oral insulin molecule IN 105, which is being developed as a tablet with US company Nobex, the domestic major has started pre-clinical studies. It plans to file an INDA (investigative new drug application) with the US FDA by this year-end.

Biocon is considering whole molecule licences for oral insulin and is in talks with two companies, according to Mr Ajay Bhardwaj, President-Marketing.

Biocon and its Cuban partner, CIMAB, are developing five monoclonal antibodies (MAbs) to treat various types of cancer. Of them, Biomab, an EGFR antibody, is undergoing phase 2b trials on 75 patients in three centres in India and is in phase 3 in Cuba.

Biomab would be moved for fast-track regulatory approval in a couple of months after completing the trials and go for market approval during the first quarter of next fiscal. "We will hit the Indian market if not this fiscal, then the next (fiscal)," Ms Mazumdar-Shaw said. The MAbs are said to be currently an $8-billion global proposition and Biomab offers a huge market opportunity as it can be extended to treating tumours in head and neck, lungs, pancreas, breast and brain. Biocon's Rs 100-crore facility for MAbs is gearing up for commissioning in early 2006.

Also in the pipeline are three cancer vaccines and a molecule called anti-CD6 for leukaemia. Trials in Cuba for the EGF-based vaccine have shown good results and could be the first Indian cancer vaccine, she said.

On a parallel track, Biocon and US company Vaccinex Inc, are working on two other antibodies — BVX 10 fore rheumatoid arthritis and BVX 20 for non-Hodgkin's lymphoma.

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