Biocon Ltd, India's premier Biotechnology Company, has announced the launch of BIOMAb-EGFR a therapeutic monoclonal antibody-based drug for treating solid tumours of epithelial origin, such as head and neck cancers. This novel drug is engineered to specifically target and block the epidermal growth factor receptor (EGFR) responsible for the proliferation of cancer cells. Padmashri Shah Rukh Khan launched BIOMAb-EGFR. R Ashok, Honourable Minister for Health and Family Welfare, Government of Karnataka was also present at the launch.
BIOMAb-EGFR will be available as a unit carton of four 10 ml vials and has been launched across the country. The drug is the first of its kind to be clinically developed in India and is the first anti-EGFR humanized monoclonal antibody for cancer to be made available commercially anywhere in the world. The product has shown consistent response in clinical trials initiated both in India and globally and will later be extended to other indications. BIOMAb-EGFR will be produced at Biocon's state-of-the-art manufacturing facility Biocon Park.
Announcing the launch of BIOMAb-EGFR, Dr Kiran Mazumdar-Shaw, chairman and MD, Biocon Ltd said, "This launch spearheads Biocon's foray into proprietary immunotherapeutics and today we join the exclusive league of monoclonal antibody developers worldwide. While therapeutic monoclonal antibodies have been introduced in the country, they are beyond the reach of a majority of cancer patients because of their prohibitive cost. BIOMAb-EGFR is competitively priced, making cancer treatment more affordable. We aspire to become a key player in this segment."
Immunotherapeutics is a new class of drugs that effectively address unmet needs, particularly in oncology and autoimmune diseases such as Rheumatoid Arthritis, Psoriasis, and Lupus. Immunotherapy is the most recent form of treating such diseases wherein use of antibodies and vaccines play a key role in disease management.
BIOMAb-EGFR targets the human Epidermal Growth Factor Receptor (EGFR), a type of protein found on the surface of both normal and cancer cells. Small proteins circulating in the blood, called Epidermal Growth Factors (EGF), bind with the EGFR. The binding action stimulates certain biological processes within the cell to promote cell growth in a controlled manner. However, in many cancer cells EGFR is overproduced, leading to their uncontrolled and abnormal growth. This pivotal role of EGFR in malignant cell formation has prompted the development of biological agents, such as BIOMAb-EGFR that disrupts and inhibits the EGFR signaling process.
BIOMAb-EGFR is indicated for use in combination with radiation therapy/chemotherapy in patients with positive expression of EGFR in squamous cell carcinoma of head and neck cancer. In clinical trials BIOMAb-EGFR showed extensive proliferation inhibition activity in non-small cell lung cancer, breast cancer, colorectal cancer, pancreatic cancer, and glioblastoma (brain tumours).
The incidence of cancer is alarmingly high in India: approximately 100 per 100,000 population, and the highest rates of head and neck cancers are reported in South Asian countries such as India and Sri Lanka. In fact, the Indian sub-continent accounts for one-third of the world burden of head and neck cancers. Smoking and chewing of tobacco in combination with excessive consumption of alcohol are the most important risk factors.
The present global market size of monoclonal antibodies is estimated at $ 15 billion, and is expected to double by 2010.