The latest news from academia, regulators
research labs and other things of interest
Posted: October 18, 2007
Abraxis BioScience Receives a Positive Opinion in Europe for the Approval of ABRAXANE
(Nanowerk News) Abraxis BioScience, Inc. (NASDAQ:ABBI), an integrated, global biopharmaceutical company, today announced that ABRAXANE® powder for suspension for infusion (an albumin-bound nanoparticle formulation of paclitaxel), has received a positive opinion in favor of approval from the European Committee for Human Medicinal Products (CHMP) for the treatment of metastatic breast cancer in women who have failed therapy in the first-line setting. The CHMP positive opinion was based on the clinical trial data that supported the approval of ABRAXANE in the United States and Canada. In that trial, ABRAXANE demonstrated significant superiority in the clinical endpoints of response rate, progression free survival and survival when compared with Taxol® in the proposed indication in metastatic breast cancer.
"We are pleased that the CHMP has recommended approval of ABRAXANE for the treatment of metastatic breast cancer and look forward to receiving the final approval over the next few months and establishing our presence in Europe," said Patrick Soon-Shiong, M.D., chairman and chief executive officer of Abraxis BioScience. "More importantly, we believe this positive opinion is an important step in offering women diagnosed with breast cancer across Europe a more effective, convenient and well-tolerated alternative to solvent-based formulations of paclitaxel."
The positive opinion from the full scientific panel was based on the review of a marketing authorization application (MAA) using the centralized registration procedure. Abraxis BioScience has now begun the process of establishing a European infrastructure for the commercialization of ABRAXANE across Europe. The launch of ABRAXANE in Europe by Abraxis will initially focus on the United Kingdom, France, Spain, Italy and Germany.
The positive opinion from the CHMP is the final step before formal approval to market ABRAXANE in Europe. A formal decision by the European Commission on marketing authorization is expected within the next three to four months.
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 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, 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 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 expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the approval and launch of Abraxane in Europe. 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 market acceptance of Abraxane in Europe, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing, 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 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.