Abraxis BioScience Announces Plan to Create Abraxis Health, a New Enterprise Focused on Biomarkers and Personalized Medicine
Abraxis BioScience to Continue Core Focus on Global Commercialization of ABRAXANE Oncology Franchise, Robust Phase 3 Clinical Program and Proprietary nab® Technology Platform Abraxis Health to Pioneer New Paradigm in Healthcare Delivery Rooted in Evidence-Based Medicine and Bioinformatics Abraxis BioScience Shareholders to Receive Shares of the Newly Formed Abraxis Health Company in Accordance With Percentage Ownership of Abraxis BioScience as well as Continue to Hold Existing Shares of Abraxis BioScience
Tuesday January 20, 2009, 8:05 am EST
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* Abraxis BioScience, Inc.
LOS ANGELES--(BUSINESS WIRE)--Abraxis BioScience, Inc. (NASDAQ:ABII - News), a fully integrated, global biotechnology company, announced today that the Board of Directors has approved a strategic plan to create Abraxis Health, Inc., an independent, stand-alone company to be spun-off from Abraxis BioScience that will be dedicated to becoming a fully integrated, next-generation, evidence-based, personalized healthcare company.
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“The opportunity that lies in front of Abraxis BioScience is enormous and is a result of the validated science underlying the company’s proprietary nab® technology in the clinical setting,” said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. “In 2009, we plan to initiate nine pivotal registrational trials in multiple tumor types, including breast cancer, lung, melanoma and pancreatic cancers. In addition, Abraxis has initiated 65 investigator-sponsored Phase 2 studies and 16 Phase 1 studies. Together with the current approval of ABRAXANE in 36 countries and the continuing need to establish infrastructure for the global launch of this compound, the immense and exciting task that lies ahead should be the primary focus of Abraxis BioScience.”
Abraxis BioScience will be solely dedicated to building its ABRAXANE franchise on a global basis, advancing an extensive Phase 3 clinical program, and leveraging its proprietary nab® technology platform. For the nine months ended September 30, 2008, Abraxis reported revenue from sales of ABRAXANE of $245.8 million.
Selected Abraxis BioScience planned advanced clinical trials are summarized in the following table:
Compound Indication Stage of
Clinical Study
ABRAXANE® 1st line breast cancer Phase 3
1st line lung cancer Phase 3
1st line melanoma Phase 3
1st line pancreatic cancer Phase 3
2nd line pancreatic cancer Phase 3
1st line ovarian cancer Phase 3
1st line gastric cancer Phase 2
nab®-docetaxel 2nd line lung cancer Phase 3
1st line prostate cancer Phase 3
1st line breast cancer Phase 2
Abraxis Health – Pioneering Personalized Medicine
Abraxis Health has been created to focus on generating biological systems and advancing personalized medicine through strategic alliances and internal development. The company believes that the era of predictive, personalized evidence-based medicine has emerged. Therefore its strategic focus will be to identify compounds with specific activity linked to specific biological markers related to specific disease states.
“Abraxis Health will become a pioneer in the burgeoning area of personalized medicine, creating a new paradigm in medical care,” stated Dr. Soon-Shiong, who will become Chairman and Chief Executive Officer of the newly established company. “To do this we must evaluate biological systems in personalized medicine and change the way we develop drugs and how we identify the patient for whom we are developing new drugs. We believe that, based on our proof of principle learned from our decade of research with the nab® platform, we must look at patients as biological systems using bioinformatics to identify chemical and biological entities. We envision a day when a tissue sample can be used to develop the molecular profile of disease which will guide a patient’s therapeutic approach, enabling caregivers to deliver the most effective medicine to the right patient at the right time. Unlike Abraxis BioScience, Abraxis Health’s mission is to pursue early stage development of compounds utilizing new technologies with new methodologies. The company’s R&D program will be led by a team of discovery scientists, medicinal chemists and formulation scientists who will devote their efforts to advancing molecules from the lab to the clinic.”
“We believe we are able to use the molecular profile of disease to deliver the right medicine to the right patient at the right time,” continued Dr. Soon-Shiong. “This will require a novel, global healthcare infrastructure with seamless communication among its various components, including: a network of tissue resources; a national tissue repository; next-generation diagnostic and molecular interrogation techniques; validated and quantitative norms to differentiate normal from disease states; a network of clinical sites working in collaboration to identify cohorts of patients with similar abnormal molecular profiles; and iterative clinical testing program to evaluate drugs based on activity against the particular molecular profile; and, a bioinformatic infrastructure integrating all of these elements.”
In connection with the spin-off, Abraxis Health will obtain the assets and liabilities constituting the drug discovery, pilot manufacturing and development operations currently being conducted through Abraxis BioScience. Detailed information about the spin-off will be provided when the company files a Form 10 registration statement with the Securities and Exchange Commission for Abraxis Health, which is expected to be filed in the first quarter of 2009.
The completion of any spin-off transaction will be subject to customary conditions, including filing of required documents with the Securities and Exchange Commission. There can be no assurance that any spin-off transaction will ultimately occur or, if one does occur, its terms or timing.
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 nab® platform. The first FDA approved product to use this nab® platform, ABRAXANE, was launched in 2005 for the 2nd line 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 spin-off of the drug discovery and development business and the clinical development plan for 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, but are not limited to, risks that the proposed spin-off disrupts current plans and operations and the potential difficulties in employee retention; the inability to recognize the benefits of the spin-off; the difficulties or delays in developing, testing, obtaining regulatory approval of, and producing and marketing of their products; the impact of competitive products and pricing; the availability and pricing of ingredients used in the manufacture of pharmaceutical products; and the ability to successfully manufacture products in a time-sensitive and cost effective manner. Additional relevant information concerning risks can be found in Abraxis BioScience's Form 10-K for the year ended December 31, 2007 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.
Contact:
Investor and Media Inquiries
Abraxis BioScience, Inc.
Maili Bergman
Director, Investor Relations and Corporate Communications
310-405-7522
or
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Rob Whetstone
310-279-5963
