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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® 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™ (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."
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).
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, please visit http://www.abraxisbio.com .
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-EGFRTM. Visit us at http://www.biocon.com .
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, please visit http://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.
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 its planned clinical trials. 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. These factors include, without limitation, the fact that results from pre-clinical studies may not be predictive of results to be obtained in the clinical trial, delays in commencement and completion of the clinical trial, including slower than anticipated patient enrollment and adverse events occurring during the clinical trial, 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.
The information contained in this press release is as of the date of this release. Abraxis assumes no obligations to update any forward-looking statements contained in this press release as the result of new information or future events or developments.
Taxol® is a registered trademark of Bristol-Myers Squibb company.
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Abraxis BioScience, Inc.
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for Biocon Limited
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