Biocon Biopharmaceutical Private Limited (BBPL) has invested Rs 100 crore for its cell culture fermentation and aseptic unit for the development of oncology, auto immune and metabolic drugs.

The maiden monoclonal anti body product from the facility is the BIOMAb EGFR (epidermal growth factor receptor) for head and neck cancer, which will be filed for approval from the Drugs Control General of India within a month. The drug, which has already undergone clinical trials at hospitals in Bangalore and Mangalore, will be also tested be on patients at hospital in leading metros in the country.

According to Dr. Kiran Mazumdar-Shaw, chairman and managing director, Biocon Limited, immuno therapy is a new class of drugs for treatment of dreaded diseases. Currently, 18 antibodies have been approved for drug development globally and 30 percent of the drugs in the approval stage by US FDA are monoclonal antibodies. The clinical trials conducted so far have shown positive sign in disease regression and disease survival with regards to BIOMAb EGFR.

BIOMAb EGFR will treat head and neck cancers which affects the mouth, nasal cavities, sinuses, larynx and pharynx. In India, cancer affects 3 million population and there are 7 lakh new cases a year. There are over 2.6 lakh tobacco related head and neck cancer cases annually in the country. The EGFR's are responsive to solid tumours, co-rectal and brain glioma cancers.

The cost of development of drugs via the monoclonal antibody route is expensive but Biocon has made efforts to ensure that the drug is accessible and affordable, because of the company's co-development programme with the Cuban Institute CIMAB representing the Centre for Molecular Immunology, Cuba for EGFR which has enabled reduction in drug development time-frame and cost, stated Dr. Shaw.

Dr. Shaw also stated there was absolutely no connection between the MAb being developed by Biocon and the one (TGN1412) being tested in the United Kingdom by an unconnected German company.