Biocon receives DCGI nod to market Abraxane
Business Line | 19th Oct 2007(Friday)

Biocon Ltd and Abraxis BioScience, Inc., has announced the approval to market ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for Injectable suspension) (albumin-bound) in India for the treatment of breast cancer by the country's Drug Controller General. Commercial introduction of ABRAXANE in the Indian market is expected in 2008 following the completion of the appropriate importation certifications. In August 2007, Biocon and Abraxis announced an agreement for the commercialization of ABRAXANE in India by Biocon. Under the terms of the agreement, Biocon will have the right to market ABRAXANE in India, Pakistan, Bangladesh, Sri Lanka, the United Arab Emirates, Saudi Arabia, Kuwait and certain other South Asian and Persian Gulf countries. Abraxis BioScience will be initiating a worldwide head-to-head Phase III registration trial comparing weekly ABRAXANE to every three week Taxotere for the treatment of first-line metastatic breast cancer as well as Phase III trials for the treatment of non-small cell lung cancer and melanoma. ABRAXANE is currently under active review in Australia, Russia, China and the European Union by their respective regulatory agencies. Kiran Mazumdar Shaw, chairman and managing director, Biocon Ltd said, "This is a significant step for Biocon's innovation led Oncotherapeutics division in our endeavor to bring new therapeutics for Indian cancer patients. There is a huge need for ABRAXANE in the treatment of breast cancer in the country and we look forward to attaining market leadership in this segment. "ABRAXANE is an important addition to Biocon's Oncotherapeutics portfolio which has already seen the successful launch of its proprietary antibody, BIOMAb EGFR for the treatment of head and neck cancers. The approval of ABRAXANE in India was based on the clinical trial data that was the basis of approval in the United States. In that trial, ABRAXANE demonstrated a superior response rate with an almost doubling of the reconciled target lesion response rate when compared with Taxol in a prospectively randomized trial of 460 patients with metastatic breast cancer. ABRAXANE uses albumin, a human protein, to deliver the active ingredient paclitaxel. Unlike other chemotherapy treatments, ABRAXANE does not contain chemical solvents, which eliminates the need for pre-medication with steroids or antihistamines often needed to prevent the toxic side effects associated with solvents. ABRAXANE is administered in 30 minutes (as compared to three hours for solvent-based paclitaxel).

News Index