Biocon’s novel oncology drug Biomab (h-R3), a unique Monoclonal Antibody (MAb), for the treatment of head and neck cancers, is now in the phase IIb human clinical trial phase and the study is on at three medical centres in Karnataka. The state has a total of 1.5 lakh cancer patients and 35,000 new cases annually.
 
The company expects to file Biomab for fast track approval in the country by the end of 2005. The clinical trials are being co-ordinated by Clinigene, its subsidiary. The trials are on at three leading hospitals in the state which include Kidwai Memorial Institute of Oncology, Manipal Hospital in Bangalore and Mangalore. Seventy-five patients are undergoing the trial, which is a double blind study.
 
The response rates of the trial are encouraging because of a positive outcome on patients with Biomab, stated Kiran Mazumdar Shaw, chairman and managing director, Biocon Limited. The drug will be of a great advantage to India, where head and neck cancers account for 80,000 patients annually out of 7 lakh patients in the country. The therapeutic advantages of the drug will be extended to Pancreatic, Colo-rectal, Lung, Breast and brain tumours, she added.
 
Going by the capabilities in research and development, the company is focusing in the immuno-therapy space and through Biocon Biopharmaceuticals Pvt. Ltd., which is a joint venture with Cuban Institute CIMAB, it has partnered to develop a range of monoclonal antibodies and cancer vaccines. 

“Our partnership will help integrate CIMAB’s expertise in development and production of oncology products,” stated Ms. Shaw.
 
Currently, there are 17 MAb products in the global market with two    blockbuster drugs - rituximab, sold under the brand name Rituxan by Biogen Idec, for the treatment of non-Hodgkin’s lymphoma and Herceptin, developed by Genentech for solid tumours.
 
The market for MAbs is pegged at around $8 billion and is expected to grow to $17 billion in 2008. “In the wake of such potential, Biocon Biopharmaceuticals will spearhead its entry into proprietary products for cancer therapy which will allow it to have a niche presence,” she added.

Another product under development is the Anti-CD6 which is for patients with Chronic Lymphocytic Leukaemia.