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Abraxis Also to License Five Biosimilar Products
Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, today announced that it has granted an exclusive license to Green Cross Corporation for the commercialization of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in Korea. Through this agreement, Green Cross will pay a royalty on net sales of ABRAXANE in Korea as well as upfront and milestone payments.
Green Cross is responsible for the commercialization of ABRAXANE in Korea and will employ an exclusive sales force following regulatory and pricing approval for ABRAXANE in that country. ABRAXANE is currently co-promoted in the United States with AstraZeneca. Other global partnerships for the commercialization of ABRAXANE are with Taiho Pharmaceuticals in Japan and Biocon Limited in India.
ABRAXANE is based on Abraxis' proprietary tumor targeting technology known as the nab™ technology platform. This nab technology platform is the first to maximize the tumor's biology against itself, taking advantage of an albumin-specific, receptor-mediated transport system and allowing the delivery of a drug from the vascular space across the blood vessel wall to the underlying tumor tissue.
In addition, Green Cross has granted an exclusive license to Abraxis for the future commercialization of the following biosimilars in the U.S. and Canada: erythropoetin, pegylated G-CSF (granulocyte-colony stimulating factor), Interferon-Alpha, recombinant Factor VIII, and etanercept. Abraxis is responsible for the clinical development and regulatory approval. Interferon Alpha has been launched in Korea by Green Cross. Green Cross plans to file for regulatory approval with the Korean FDA for recombinant Factor VIII in the first quarter of 2008, and Green Cross has completed Phase III studies for erythropoetin. Pegylated GCSF and etanercept are in early stages of development. Abraxis will pay a milestone on each product once approval has been received and a royalty on net sales.
The U.S. Food and Drug Administration approved ABRAXANE(R) 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(R) please visit http://www.abraxane.com .
About Abraxis BioScience, Inc.
Abraxis BioScience is a fully integrated biotechnology company dedicated to the discovery, development and delivery of next-generation therapeutics and core technologies that offer patients and medical professionals safer and more effective treatments for cancer and other critical illnesses. The Abraxis portfolio includes the world’s first and only protein-based nanoparticle chemotherapeutic compound (ABRAXANE) which is based on its proprietary tumor targeting system known as the nab™ technology platform. From the discovery and research phase to development and commercialization, Abraxis BioScience is committed to rapidly enriching the company’s pipeline and accelerating the delivery of breakthrough therapies that will transform the lives of the patients who need them. Abraxis, with headquarters in Los Angeles, California, trades on the Nasdaq Global Market under the symbol “ABII”. For more information about the company and its products, please visit http://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 development and commercialization of the licensed products. 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, unexpected safety, efficacy or manufacturing issues, the difficulties or delays in developing, testing, obtaining regulatory approval of, and producing and marketing of products, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing 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 Abraxis BioScience’s Registration Statement on Form 10 filed under the company name New Abraxis, Inc. 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.
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