Biocon gets DCGI nod for cancer drug

Biotechnology major Biocon has got the Drug and Controller General of India (DCGI) approval for marketing its BIOMAb EGFR in the Indian market. This is a proprietary product of Biocon which will be used in treating head and neck cancers.

Kiran Mazumdar-Shaw, chairman and managing director, disclosed this at the announcement of its first quarter results here on Wednesday.

Shaw said the company's innovation-led strategy was on target. The product will be later extended to other indications such as colorectal (cancer that develops in the colon), brain, breast, pancreatic and lung cancers.

The company is betting big on the product and it is expected to spearhead Biocon Pharmeceuticals' foray into proprietary products for cancer therapy.

Biocon is also optimistic about monoclonal antibodies (used in basic biomedical research, in diagnosis of disease and in treating illnesses) which is emerging as the fastest growing segment.

Its use is especially growing in oncology and auto-immune diseases such as rheumatoid arthritis, psoriasis and lupus (a chronic inflammatory connective tissue disease). The present global market size of monoclonal antibodies is $15 billion, and is expected to double by 2010.

In India it is estimated that there are about 3 million cancer patients and about 0.7 million are new cases, of which 0.23 million are tobacco-related head and neck cancer.

On the oral insulin front, Kiran Mazumdar-Shaw said the company has commenced phase I human clinical trials of its oral insulin molecule (IN105) to establish the proof of concept of its proprietary oral delivery technology, recently acquired from Nobex.

"The studies are expected to be completed by the third quarter of 2006-07 and will be used to support investigational new drug filings with international regulatory authorities," she added.