Bangalore, August 09, 2007
Bangalore/Los Angeles - (August 09, 2007) -Biocon Limited, India's leading biotechnology company and Abraxis BioScience,Inc.(NASDAQ ABBI), an integrated, global biopharmaceutical company, today announced a licensing agreement for the commercialization of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in India. Under the terms of the agreement, Biocon will also have the right to market ABRAXANE® in Pakistan, Bangladesh, Sri Lanka, United Arab Emirates, Saudi Arabia, Kuwait and certain other Persian Gulf countries. As part of this agreement, Abraxis will receive royalties from Biocon based on net sales of ABRAXANE® in these countries.
"ABRAXANE® adds tremendous value to our innovation led Oncotherapeutics marketing strategy. Biocon is committed to bringing new therapeutics for the benefit of patients both in India and other regions of the world through in-house and licensed products. Our partnership with Abraxis on multiple fronts is enabling us to realize this objective in an effective and expedious manner said Kiran Mazumdar-Shaw, Chairman and Managing Director, Biocon Limited."
In July 2007, Abraxis submitted to India's Ministry of Health and Family Welfare an application to market ABRAXANE® for the treatment of breast cancer.
"This agreement is an important step in the development of a global commercialization framework that incorporates unique country-by-country needs,"said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. "Importantly, we are pleased that this partnership with Biocon affords us the opportunity to bring ABRAXANE, an portant advance in chemotherapy, to these countries."
The U.S. Food and Drug Administration approved ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. The most serious adverse events associated with ABRAXANE in the randomized metastatic breast cancer study for which FDA approval was based included neutropenia, anemia, infections, sensory neuropathy, nausea, vomiting, and myalgia/arthralgia. Other common adverse reactions included anemia, asthenia, diarrhea, ocular/visual disturbances, fluid retention, alopecia, hepatic dysfunction, mucositis, and renal dysfunction. For the full prescribing information for ABRAXANE®
ABRAXANE® was developed by Abraxis BioScience, Inc. ABRAXANE® is marketed in the United States under a co-promotion agreement between Abraxis and AstraZeneca Pharmaceuticals LP.
About Biocon Limited
Established in 1978, Biocon Limited is one of India's premier biotechnology companies. Biocon and its two subsidiary companies, Syngene International Ltd and Clinigene International Ltd form a fully integrated biotechnology enterprise, specializing in biopharmaceuticals, custom research, clinical research and enzymes. With successful initiatives in clinical development, bio-processing and global marketing, Biocon delivers products and solutions to partners and customers across the globe. Many of these products have USFDA and EMEA acceptance. Biocon launched the world's first recombinant human insulin, INSUGEN in November 2004 using Pichia expression and India's first indigenously produced monoclonal antibody BIOMAb-EGFR™;. Visit us at www.biocon.com
About Abraxis BioScience, Inc.
Abraxis BioScience, Inc. is an integrated global biopharmaceutical company dedicated to meeting the needs of critically ill patients. The company develops, manufactures and markets one of the broadest portfolios of injectable products and leverages revolutionary technology such as its nab platform to discover and deliver breakthrough therapeutics that transform the treatment of cancer and other life-threatening diseases. The first FDA approved product to use this nab platform, ABRAXANE®, was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the Nasdaq Global Market under the symbol ABBI. For more information about the company and its products.
The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the development of the licensed intellectual property portfolio. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward- looking statements. The development of the licensed intellectual property portfolio could be affected by a number of factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in Abraxis BioScience's Form 10-K for the year ended December 31, 2006 and other documents it has filed with the Securities and Exchange Commission.
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