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Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, today announced that the Korean FDA (KFDA) has granted marketing approval for ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease. The Phase III clinical trial results on which this approval was based demonstrated that ABRAXANE doubled the response rate and significantly prolonged progression-free survival and overall survival versus Taxol® in the approved indication. ABRAXANE is now approved for marketing in 34 countries.
As previously announced, Abraxis granted an exclusive license to Green Cross Corporation for the commercialization of ABRAXANE in Korea. Green Cross made an upfront payment and will pay a royalty on net sales of ABRAXANE in Korea as well as milestone payments. In a separate agreement, 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. Interferon Alpha has been launched in Korea by Green Cross. Green Cross filed for regulatory approval with the KFDA for recombinant Factor VIII in the second quarter of 2008 and Green Cross has completed Phase III studies for erythropoetin. Pegylated GCSF and etanercept are in early stages of development. Once approval has been received, Abraxis will pay Green Cross a milestone on each product in addition to royalties on net sales.
Green Cross currently expects to launch ABRAXANE in Korea in the first quarter of 2009 following pricing approval. Green Cross plans to establish a dedicated sales force for ABRAXANE and implement various marketing campaigns to support a successful launch. Abraxis has two additional global partnerships for the commercialization of ABRAXANE with Taiho Pharmaceuticals in Japan and Biocon Limited in India.
"The approval for ABRAXANE in Korea provides an effective new treatment option to physicians and patients in Korea in the fight against metastatic breast cancer. We look forward to expanding the global market presence of ABRAXANE," said Patrick Soon-Shiong, M.D., chairman and chief executive officer of Abraxis BioScience.
"This approval represents an exciting new direction for Green Cross's oncology business and we are very pleased to bring this unique and efficacious drug to cancer patients in Korea," said B.G. Rhee, Ph.D., executive vice president of Green Cross.
In Korea, there are approximately 20,000 cases of metastatic breast cancer. The Korean oncology market for 2007 is estimated at US$533 million of which the chemotherapy market and its taxanes component are estimated at US$400 million and US$77 million, respectively, per IMS.
In addition to the approval in Korea, ABRAXANE is approved for marketing in the U.S. and is currently co-promoted in collaboration with AstraZeneca Pharmaceuticals LP. ABRAXANE is the fastest growing taxane in the U.S.
ABRAXANE was approved in Canada in 2006 for the treatment of metastatic breast cancer including first-line disease. ABRAXANE was approved in India in November 2007 for the second-line treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Most recently, ABRAXANE was approved in the European Union in January 2008 for the treatment of metastatic breast cancer. ABRAXANE is currently under active review in Australia, Russia and China by their respective regulatory agencies.
ABRAXANE, the first in a new class of protein-bound nanoparticle drugs utilizing the company's proprietary nanoparticle albumin-bound (nab™) technology, is currently in various stages of development for the treatment of the following cancers: first-line metastatic breast, non-small cell lung, malignant melanoma, pancreatic, gastric, and head and neck.
The U.S. Food and Drug Administration (FDA) approved ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in 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.
ABRAXANE uses albumin, a human protein, to deliver the active ingredient paclitaxel. Unlike some other chemotherapy treatments, ABRAXANE does not contain chemical solvents, which eliminates the need for pre-medication with steroids or antihistamines often needed to prevent the toxic side effects associated with solvents. ABRAXANE is administered in 30 minutes as compared to three hours for solvent-based paclitaxel.
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.
ABRAXANE was developed by Abraxis BioScience, Inc. ABRAXANE is marketed in the United States under a co-promotion agreement between Abraxis and AstraZeneca Pharmaceuticals LP.
About Green Cross
Green Cross, a leader in the Korean biotechnology and pharmaceutical industries, is a fully integrated, internationally recognized biotechnology company dedicated to the research, development and marketing of products such as vaccines and biopharmaceuticals. Green Cross has successfully developed vaccines for Hepatitis B (Hepavax), Epidemic Hemorrhagic Fever (Hantavax) and chicken pox. The company manufactures the only seasonal influenza vaccine in Korea and is developing an avian influenza vaccine as well as recombinant Factor VIII and IX for hemophilia, and recombinant PTH for severe osteoporosis. In oncology, Green Cross is developing Greenstatin (anti-angiogenic peptide) and modified PEG-G-CSF for neutropenia. For more information about the company and its products, please visit www.greencross.com.
About Abraxis BioScience, Inc.
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-based nanoparticle 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 treatment of metastatic breast cancer. 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.
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 launch of ABRAXANE in Korea. 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 market launch of ABRAXANE in Korea, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing, 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, 2007 and other filings 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.
Taxol® is a registered trademark of Bristol-Myers Squibb Company.
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Abraxis BioScience, Inc.
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