Healthcare Industry News: paclitaxel
News Release - August 8, 2007
Abraxis BioScience Announces Licensing Agreement with Biocon Limited for the Commercialization of ABRAXANE in IndiaLOS ANGELES--(HSMN NewsFeed)--Abraxis BioScience, Inc. (NASDAQ:ABBI ), an integrated, global biopharmaceutical company, today announced a licensing agreement with Biocon Limited, India's leading biotechnology company, for the commercialization of ABRAXANEŽ (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, the United Arab Emirates, Saudi Arabia, Kuwait and certain other South Asian and Persian Gulf countries. As part of this agreement, Abraxis will receive royalties from Biocon based on net sales of ABRAXANE in these countries.
"This agreement is an important step in the development of a global commercialization framework that incorporates unique country-by-country needs," said Bruce Wendel, executive vice president, Corporate Development for Abraxis BioScience. "Importantly, we are pleased that this partnership with Biocon affords us the opportunity to bring ABRAXANE, an important advance in chemotherapy, to these countries while broadening our existing relationship with Biocon, one of the leading biotechnology companies in India."
In July 2007, Abraxis submitted to India's Ministry of Health and Family Welfare an application to market ABRAXANE in India for the treatment of breast cancer.
The U.S. Food and Drug Administration approved ABRAXANEŽ 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 ABRAXANEŽ, please visit www.abraxane.com.
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, INSUGENŽ, in November 2004 using Pichia expression and India's first indigenously produced monoclonal antibody BIOMAb-EGFR(TM). 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(TM) 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, ABRAXANEŽ, 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, please visit www.abraxisbio.com.
Source: Abraxis BioScience
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