Biocon to file for approval of cancer drug soon

Biocon Biopharmaceuticals, a Biocon subsidiary which has completed the clinical trials for BIOMAb EGFR, a novel monoclonal antibody for the treatment of head and neck cancer, will file for regulatory approval in a month. The final product is likely to be launched by the end of the year.

Kiran Mazumdar-Shaw, chairman and managing director, Biocon, speaking to reporters after the inauguration of Biocon Biopharmaceuticals' facility here on Monday said that the clinical trials were conducted at Manipal Hospital in Bangalore and KMC hospitals in Mangalore and Manipal.

"It is now for the regulators to look at the data and approve it. We are in the process of compiling the data and filing it before the Drug Controller General of India (DGCI) for approval. We will be filing it next month," she added.

BIOMAb EGFR is engineered to specifically target and block the epidermal growth factor receptor (EGFR) responsible for the proliferation of cancer cells. BIOMAb EGFR will spearhead Biocon Biopharmaceuticals' foray into proprietary products for cancer therapy in India.

Biocon Biopharmaceuticals' immunotherapeutic portfolio is a comprehensive approach targetting both receptors (EGFR & HER1) and proliferation factors (EGF & TGF) aimed at complete remission and possible cure, said Kiran Mazumdar-Shaw. Cuba's CIMAB, which originally identified the BIOMAb EGFR molecule, has entered into codevelopment agreements with firms in China and Germany, as also Biocon.

"BIOMAb EGFR being developed in India is exclusively for marketing in India and South Asia. There is also a supply arrangement with CIMAB for selling it in the US market," she said.

It is estimated that the incidence of new cancer cases in India is about seven lakh annually of which nearly 2.3 lakh are tobacco-related and occur in the head and neck region. In addition to head and neck cancer, monoclonal antibodies are emerging as the fastest growing segment especially in auto-immune diseases like rheumatoid arthritis.

There are about 18 monoclonal antibodies approved globally for therapeutic use with the present market size of $15 billion. This is expected to double by 2010, said Kiran Mazumdar-Shaw.