LOS ANGELES--(BUSINESS WIRE)--Sept. 7, 2006--Abraxis BioScience, Inc. (NASDAQ:ABBI - News), an integrated, global biopharmaceutical company, met today with the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) to discuss the need for a randomized trial to support the approval of ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for use in the adjuvant treatment of node-positive breast cancer. ODAC panel members recommended that Abraxis and the FDA work together to identify selected patient populations for a “reasonably sized”, randomized trial to confirm safety and efficacy of ABRAXANE leading to approval as adjuvant treatment. The FDA generally follows the advice of the panel, however, they are not bound by the Committee’s recommendations.
“We are encouraged by the ODAC panel’s recommendation and we intend to move as quickly as possible to discuss the next steps with the FDA. If the FDA agrees with today’s recommendation by the Committee, this may enable approval in this indication earlier than typically expected,” stated Michael J. Hawkins, M.D., chief medical officer of Abraxis BioScience. “We look forward to continuing to work with the FDA on the development of ABRAXANE for additional indications.”
ABRAXANE is currently approved in the U.S. 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.
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.
About ABRAXANE®
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. 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 National Market under the symbol ABBI. For more information about the company and its products, please visit www.abraxisbio.com.
FORWARD-LOOKING STATEMENT
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 expansion. 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, recommendations by the Oncologic Drugs Advisor Committee regarding pathway for approval of ABRAXANE in the adjuvant treatment of breast cancer, 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 Form 10-K for the year ended December 31, 2005 and other documents it has filed with the Securities and Exchange Commission.
Taxol® is a registered trademark of Bristol-Myers Squibb Company.
Contact: Abraxis BioScience, Inc. Christine Cassiano, 310-826-5102 (Investors and Media) Onsite: 714-552-0326 Claire Campbell, 908-393-8238 (Media) Onsite: 310-463-5047
Source: Abraxis BioScience, Inc.
