Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated, global biotechnology company, today announced that Taiho Pharmaceutical Co., Ltd. has received approval from the Ministry of Health, Labor and Welfare to market ABRAXANE® IV Infusion 100 mg, Paclitaxel Injection (Suspension with Albumin), for use in the treatment of breast cancer. The New Drug Application (J-NDA) for ABRAXANE was filed with the Ministry of Health, Labor and Welfare in 2008.
In 2005, Abraxis entered into a license agreement with Taiho Pharmaceutical, a leading company within the Otsuka Holdings Group, under which Abraxis granted to Taiho the exclusive rights to market and sell ABRAXANE in Japan. Abraxis and Taiho are also developing ABRAXANE in Japan for the treatment of lung and gastric cancer and other solid tumors.
“The approval to market ABRAXANE in Japan is a major step forward to providing breast cancer patients with a new treatment option,” said Patrick Soon-Shiong, M.D., Executive Chairman of Abraxis BioScience. “Our partner Taiho is working diligently to make the necessary final arrangements to launch ABRAXANE later this year. We commend their accomplishments and the tremendous cooperative efforts of our team and look forward to working closely with them so that ABRAXANE is widely and readily available to patients.”
With the approval in Japan, ABRAXANE is now approved in 40 countries. There are approximately 50,000 cases of breast cancer in Japan.