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LOS ANGELES & BANGALORE, India -- Abraxis BioScience, Inc. (NASDAQ:ABBI), an integrated, global biopharmaceutical company, and Biocon Limited, India's leading biotechnology company, today announced the approval to market ABRAXANE([R]) 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.
"The approval of ABRAXANE for the treatment of breast cancer in India is an important step in providing access to the nab[TM] (nanoparticle albumin bound) technology globally," said Patrick Soon-Shiong, M.D., chairman and chief executive officer of Abraxis BioScience. "In partnership with Biocon, we are excited to offer physicians in India this important advance in the treatment of breast cancer."
In August 2007, Abraxis and Biocon 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 Limited, 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."
ABRAXANEis 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([R]) in a prospectively randomized trial of 460 patients with metastatic breast cancer.