Healthcare Industry News: paclitaxel
News Release - October 15, 2007
Abraxis Bioscience Reaches Agreement with the FDA Following Special Protocol Assessment for Phase III Trial of ABRAXANE in Non-Small Cell Lung CancerLOS ANGELES--(HSMN NewsFeed)--Abraxis BioScience, Inc. (NASDAQ:ABBI ), an integrated, global biopharmaceutical company, today announced that it has reached a definitive agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process on the Phase III trial design of the company's pivotal study with ABRAXANEŽ for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) for the treatment of non-small cell lung cancer in the first-line setting. In the agreement, the FDA has determined that the design and planned analysis of the study addresses the objectives necessary to support a regulatory submission.
The Phase III pivotal trial is a randomized, open-label trial comparing weekly 100 mg/m2 ABRAXANE (days 1, 8 and 15 of each cycle) and 200 mg/m2 TaxolŽ (paclitaxel) Injection every three weeks. Carboplatin will be administered at AUC=6 on day 1 of each cycle repeated every three weeks in both treatment arms. The study will enroll approximately 1,000 patients with Stage IIIb and IV non-small cell lung cancer. The primary endpoint of the study is overall response rate and enrollment of this trial will begin immediately.
"We are very excited about the initiation of this clinical trial and the potential of ABRAXANE to treat people diagnosed with non-small cell lung cancer," said Patrick Soon-Shiong, M.D., chairman and chief executive officer of Abraxis BioScience. "The SPA agreement is an important step in the continued development of ABRAXANE and provides a clear pathway for an additional approved indication if the study endpoints are achieved."
About Special Protocol Assessment
The FDA's SPA process was implemented under the Prescription Drug User Fee Act (PDUFA) in November 1997. The SPA process provides for review and a binding agreement that the Phase III trial protocol design, clinical endpoints, planned conduct and statistical analyses are acceptable to support regulatory approval.
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 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, 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.
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 Phase III non-small lung cancer trial. 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, 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 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.
TaxolŽ is a registered trademark of Bristol-Myers Squibb company.
Source: Abraxis BioScience
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