Drug controller approval pending
Bangalore, June 7
Biocon Ltd's BIOMab EGFR, the first indigenously developed monoclonal antibody used in treating many cancers, has received `favourable review' from the drug regulator. With approval pending, the life-saving drug could be in the market in the next few months, according to Biocon CMD, Ms Kiran Mazumdar-Shaw.
She was speaking at an event in which the President, Mr A.P.J. Abdul Kalam, dedicated to the nation the BIOMab EGFR (epidermal growth factor receptor) and inaugurated the 90-acre, Rs 650-crore Biocon Park, which has received a captive SEZ status.
The monoclonal antibody therapy is considered one of the most promising cancer treatments. The Biocon M A b has been developed over two years with Cuban collaboration. Although M A bs have been introduced in the country, they are not affordable and the home-grown product could make a difference, she said.
Biocon said it joins the exclusive league of monoclonal antibody developers worldwide and aims to be a key player in this segment in the coming years. The President said India had missed the Human Genome Project bus and should now focus on proteomics and the futuristic gene chip-based therapies. Biocon itself should look at low-cost drugs to control HIV and infectious diseases. The new cancer drug can be used to treat cancers of head and neck, colorectal, pancreatic, metastatic breast, non-small cell lung and brain cancers.
The Biocon Park, of which 45 acres have been developed, is the country's largest integrated biotech hub with the single largest capital investment by the company, Ms Mazumdar-Shaw said. It houses the subsidiary Syngene International, Biocon Biopharmaceuticals, which will produce the antibodies in the initial phase. It employs 700 scientists and technical staff and will expand to 2,000.The park will focus on export of bio-pharmaceutical products and research services for cardiovascular problems, cholesterol reduction, immunosuppressants in organ transplantation, diabetes, and cancer.