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Bangalore - India's top biotechnology company Biocon Ltd has teamed up with US-based Abraxis BioScience, Inc. to announce the launch of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in India for the treatment of breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy.
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"ABRAXANE is now available in India as a single-use 100 mg vial (as a lyophilized powder, to be reconstituted for intravenous administration)," a press release issued by Biocon said.
"In October 2007, ABRAXANE was approved by the Drug Controller General of India. The approval was based on the clinical trial data that was the basis of approval in the United States," it said.
"The launch of ABRAXANE in India represents a major strategic step in our plan to provide safer and more effective cancer treatments on a global scale," said Patrick Soon-Shiong, M.D., chairman and CEO, Abraxis BioScience. "In addition to India, our marketing agreement with Biocon covers more than ten countries, and we are working closely with national authorities throughout the region to receive regulatory approvals and commence marketing activities as soon as practicable."
"ABRAXANE is the first nanotechnology based anti-cancer drug that is administered as albumin-bound particles of approximately 130 nanometers and takes advantage of albumin, a natural protein that acts as the body's key transporter of nutrients and other water-insoluble molecules and accumulates in tumor tissues. The drug has demonstrated superiority in progression free survival over both Taxol® Injection and Taxotere® Injection in recent randomized clinical trials. The initial clinical trials for ABRAXANE were conducted in India and we are very satisfied to be able to bring this drug to the Indian patients through our partner Biocon," said Neil Desai, Ph.D., vice president (research and development), Abraxis BioScience.
"This launch provides breakthrough therapeutics to cancer patients in India," said Kiran Mazumdar-Shaw, chairman and managing director, Biocon. "ABRAXANE is a significant advance in taxane therapy for the treatment of breast cancer. This unique product eliminates the need for chemical solvents and allows for higher doses of paclitaxel without compromising safety and tolerability. The launch of ABRAXANE reiterates our belief in strategic licensing partnerships to advance therapeutics in India, and we take great pride in providing oncologists in India with the latest treatment in breast cancer."
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