Healthcare Industry News: taxane
News Release - September 28, 2006
Abraxis BioScience Files Marketing Application with the European Medicines Agency for ABRAXANE in the Treatment of Breast CancerAbraxis to Seek a Global Partner for the Co-Promotion of ABRAXANE Outside of North America
LOS ANGELES--(HSMN NewsFeed)--Abraxis BioScience, Inc. (NASDAQ:ABBI ), an integrated, global biopharmaceutical company, today announced that the European Medicines Agency (EMEA) has accepted for review the company's application for ABRAXANEŽ for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the treatment of breast cancer. The typical EMEA review period for this centralized procedure is approximately 12 months.
In conjunction with this filing, the company has also announced its intent to seek a global commercialization partner for ABRAXANE.
"This submission to the EMEA marks an important milestone in our ongoing effort toward the global development and approval of ABRAXANE," said Patrick Soon-Shiong, M.D., chairman and chief executive officer of Abraxis BioScience. "We look forward to working closely with European regulatory authorities during the review process. We also look forward to identifying a global partner who shares our vision of providing this innovative therapy to cancer patients around the world."
The European submission is based on a randomized, pivotal Phase III multicenter, comparative study of 460 women with metastatic breast cancer conducted by the company, and published in the Journal of Clinical Oncology. This randomized trial compared ABRAXANE at a dose of 260 mg/m(2) given as a 30-minute infusion without pre-medication versus solvent-based paclitaxel injection (TaxolŽ) at 175 mg/m(2) given as a 3-hour infusion with standard steroid and antihistamine pre-medication. As reported in the European submission, patients in the ABRAXANE treatment arm had a superior investigator overall response rate of 33.2 percent, compared to 18.7 percent for patients (p=0.001) in the paclitaxel injection treatment arm. Time to Tumor Progression (TTP) was significantly prolonged in the ABRAXANE group than in the paclitaxel injection group for all patients (23.0 vs. 16.6 weeks (5.3 vs. 3.8 months), (p=0.002)). Median Progression-Free Survival (PFS) was significantly longer for the ABRAXANE group than for the paclitaxel injection group for all patients (22.7 vs. 16.6 weeks (5.2 vs. 3.8 months), (p=0.003)). No severe hypersensitivity reactions were reported in patients treated with ABRAXANE despite the absence of standard pre-medication, and peripheral neuropathies, while more frequent in the ABRAXANE treated patients, improved at a faster rate with ABRAXANE compared with Taxol. The most important adverse events included lower white and red blood cell counts, infections, tingling and numbness in the extremities, nausea, vomiting, diarrhea, muscle and joint aches, and mouth sores.
ABRAXANE is the first in a new class of protein-bound taxanes that takes advantage of albumin, a human protein and natural carrier of water insoluble molecules (e.g., various nutrients, vitamins and hormones). ABRAXANE utilizes the proprietary drug delivery system - nanoparticle albumin-bound (nab(TM)) tumor-targeting technology - to wrap albumin around the active drug. The active agent in ABRAXANE is paclitaxel, a naturally derived product with anti-tumor activity. The use of albumin eliminates the need for solvents and the associated toxicities with solvent-based paclitaxel chemotherapy.
ABRAXANE was approved in January 2005 by the U.S. Food and Drug Administration and in June 2006 by Therapeutic Products Directorate of Health Canada. Abraxis plans to file for regulatory approval of ABRAXANE in China, Japan, Korea, Taiwan, Australia, Turkey and Russia, among other countries.
About Breast Cancer
Each year more than one million new cases of breast cancer are diagnosed worldwide, with a death rate of nearly 500,000 people per year.
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. For the full prescribing information for ABRAXANEŽ please visit www.abraxane.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 National Market under the symbol ABBI. For more information about the company and its products, please visit www.abraxisbio.com.
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 expected global commercialization of ABRAXANE. 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, decisions by foreign regulatory authorities regarding whether and when to approve ABRAXANE for various indications as well their decisions regarding labeling and other matters that could affect the availability or commercial potential of ABRAXANE, unexpected safety, efficacy or manufacturing issues with respect to ABRAXANE, the need for additional data or clinical studies for ABRAXANE, regulatory developments (domestic or foreign) involving our manufacturing facilities, the market adoption and demand of ABRAXANE, the costs associated with the ongoing launch of ABRAXANE, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, the ability to successfully manufacture products in a time-sensitive and cost effective manner, the acceptance and demand of new pharmaceutical products, 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 Annual Report on Form 10-K for the year ended December 31, 2005 and in other documents it has filed with the Securities and Exchange Commission.
The information contained in this press release is as of September 28, 2006. 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.
TaxolŽ is a registered trademark of Bristol-Myers Squibb Company.
Source: Abraxis BioScience
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