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Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, today announced that its partner, Taiho Pharmaceutical Co., Ltd., has filed a Japanese New Drug Application (J-NDA) with the Ministry of Health, Labour and Welfare in Japan to market ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the treatment of breast cancer. ABRAXANE is the first and only approved protein-bound nanometer-sized solvent-free taxane and is the first commercial product to validate Abraxis' proprietary nab™ technology platform.
"The J-NDA application is an important milestone as we broaden the use of ABRAXANE on a global basis," said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. "This submission in Japan was the result of close collaboration between the Taiho and Abraxis development teams, and followed the completion of phase I bridging studies in Japan."
ABRAXANE is now approved in Europe, the U.S., India and Canada, encompassing a total of 33 countries. ABRAXANE also is under active review in Australia, Russia, Korea and China by their respective regulatory agencies.
The submission in Japan includes four clinical studies that were part of the original New Drug Application in the United States, including the randomized, pivotal Phase 3 multicenter, comparative study of 460 women with metastatic breast cancer conducted by Abraxis and published in the Journal of Clinical Oncology. This randomized trial compared ABRAXANE at a dose of 260 mg/m2 given as a 30-minute infusion without pre-medication versus solvent-based paclitaxel injection (Taxol®) at 175 mg/m2 given as a 3-hour infusion with standard steroid and antihistamine pre-medication. The Phase 3 study demonstrated that ABRAXANE doubled the response rate and significantly prolonged progression-free survival and overall survival in the approved indication, and showed comparable tolerability versus Taxol. Additionally, the submission in Japan included several subsequent Phase I and Phase 2 studies, including two conducted by Taiho.
Abraxis BioScience has entered into a license agreement with Taiho Pharmaceutical Co., Ltd., a subsidiary of Otsuka Pharmaceutical Co. Ltd., under which it granted to Taiho the exclusive rights to develop, market and sell ABRAXANE in Japan. A joint committee also was established to oversee the development of ABRAXANE in Japan for the treatment of breast, lung and gastric cancer and other solid tumors. The market for chemotherapy agents in Japan is estimated at approximately $2.6 billion in 2007.
ABRAXANE, the first in a new class of protein-bound nanometer-sized 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 was approved in Europe earlier this year, in India in 2007 and in Canada in 2006 for the treatment of metastatic breast cancer including first-line disease. The product is currently under active review in Australia, Russia, Korea and China by their respective regulatory agencies. ABRAXANE is the fastest growing taxane in its indication in the U.S. and is used in approximately 5,000 patients with metastatic breast cancer per month in North America.
ABRAXANE uses albumin, a human protein, to deliver the active ingredient paclitaxel. Unlike 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 with 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 is marketed in the United States under a co-promotion agreement between Abraxis and AstraZeneca Pharmaceuticals LP.
About Taiho Pharmaceutical Co., Ltd.
Taiho Pharmaceutical Co., Ltd. (Taiho) is a company engaged in discovery, development, manufacturing and marketing of pharmaceutical products, with its headquarters in Tokyo, Japan. Taiho is one of the leading companies focused on oncology. For more information about Taiho, please visit the company's Web site at www.taiho.co.jp/english/index.html.
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 J-NDA submission and marketing approval in Japan. 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, successfully receiving marketing approval in Japan, 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 registration statement 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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