LOS ANGELES--(BUSINESS WIRE)--Abraxis BioScience, Inc. (NASDAQ:ABII - News), a fully integrated, global biotechnology company, announced today that the company has entered into an agreement with AstraZeneca UK Limited, under which, subject to approval by the board of directors of Abraxis, the company would re-acquire the exclusive rights to market ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) in the United States.
“We believe the time has come to further build our commercialization platform for ABRAXANE in the U.S.,” said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. “We have gained much in our collaboration with AstraZeneca and they have done a commendable job in building market share. At the same time as building our sales organization, we will be advancing the development of our exciting pipeline of new nab™ product candidates, and will expand our extensive program of studies to support new indications for ABRAXANE,” continued Dr. Soon-Shiong. “In multiple tumor types, the Phase 2 data for ABRAXANE in breast, lung, melanoma and pancreatic cancer has met pre-specified endpoints resulting in the FDA and Japanese regulatory authorities agreeing to the company proceeding with pivotal trials of ABRAXANE in a number of new indications in 2009. We also anticipate initiating two Phase 3 clinical trials with our proprietary candidate nab-docetaxel.”
“There is an urgent unmet medical need to find a treatment for patients with metastatic pancreatic cancer,” said Daniel Von Hoff, M.D., principle investigator of the Phase 2 and the planned Phase 3 pancreatic cancer trials with ABRAXANE. “The results in patients participating in our Phase 2 pancreatic clinical trial are extremely encouraging and we are enthusiastic with the prospect of initiating Phase 3 clinical trials in this disease in which the survival rate thus far has been so poor.”
Abraxis has developed an extensive clinical program that the company believes will form the basis for new indications for ABRAXANE as well as other product candidates for which the company’s proprietary nab- technology platform is deployed. This program includes eight Phase 3 clinical trials, for which five protocols have been reviewed by the FDA for study design, 65 investigator-initiated Phase 2 clinical trials and 16 Phase I studies.
About Abraxis BioScience
Abraxis BioScience is a fully integrated global biotechnology company dedicated to the discovery, development and delivery of next-generation therapeutics and core technologies that offer patients safer and more effective treatments for cancer and other critical illnesses. The company’s portfolio includes the world’s first and only protein-bound chemotherapeutic compound (ABRAXANE), which is based on the company’s proprietary tumor targeting technology known as the nabTM platform. The first FDA approved product to use this nabTM platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer following failure of combination chemotherapy for metastatic disease. Abraxis trades on the NASDAQ Global Market under the symbol ABII. For more information about the company and its products, please visit www.abraxisbio.com.
FORWARD-LOOKING STATEMENTS
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 clinical development and approval of ABRAXANE and other product candidates. 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, unexpected safety, efficacy or manufacturing issues with respect to ABRAXANE or other product candidates; the need for additional data or clinical studies for ABRAXANE or other product candidates; regulatory developments (domestic or foreign) involving the company’s manufacturing facilities; the market adoption and demand of ABRAXANE, 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; 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 the company’s Annual Report on Form 10-K for the year ended December 31, 2007 and in 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.
Contact:
Investor Inquiries Abraxis BioScience, Inc. Daniel Saks Vice President, Investor Relations and Corporate Communications 310.405.7417 or Pondel Wilkinson Inc. Rob Whetstone 310.279.5963 or Media Inquiries Abraxis BioScience, Inc. Maili Bergman 310.405.7522
Source: Abraxis BioScience, Inc.
