Mar 17, 2008 - 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(R) 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(TM) 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(R)) 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.
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