- July 23, 2010
- Taiho Pharmaceutical Co., Ltd.
Abraxane® Approved for Marketing in Japan for Breast Cancer
Tokyo, July 23, 2010 — Taiho Pharmaceutical Co., Ltd., announced that today it has received approval to manufacture and market Abraxane® I.V. Infusion 100 mg in Japan, an antineoplastic for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension, albumin-bound)
The drug was approved on condition that "A Surveillance of Results of Use shall be conducted covering all cases from the launch until data are accumulated for a certain number of cases." (Excerpt) Accordingly, Taiho Pharmaceutical intends to immediately begin collecting data relating to the drug's efficacy and safety, and will take whatever measures are needed to ensure proper usage.
Abraxane® was developed by Abraxis BioScience, Inc., (NASDAQ: ABII). As a novel paclitaxel formulation for cancer treatment, Abraxane® features improved efficacy and safety as well as easier administration compared to solvent-based paclitaxel. Abraxis BioScience's propietry nab® technology could eliminate the need for steroids and other pre-medication to prevent hypersensitivity, which are required for solvent-based paclitaxel. In addition, Abraxane® shortens infusion period to 30 minutes, thereby relieving patients and potentially improving the efficiency of outpatient chemotherapy.
Abraxane® was approved by the United States Food and Drug Administration in January 2005, and is currently approved in 40 countries. There are approximately 50,000 breast cancer patients in Japan. Taiho Pharmaceutical is confident that Abraxane® will offer better treatment option for patients suffered from breast cancer.
|Product name||ABRAXANE® I.V. Infusion 100 mg|
|Date approved||July 23, 2010|
|Dosage and administration||The usual adult dosage is 260 mg/m2 of body surface area once daily, delivered via intravenous drip infusion over a 30-minute period, followed by washout period of at least 20 days. This constitutes one cycle, with administration being repeated. The dose may be reduced appropriately according to the patient's condition.|
|Condition for approval||A Surveillance of Results of Use shall be conducted covering all cases until data are accumulated for a certain number of cases|
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 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 and is now approved in 40 countries. The company continues to expand the nab platform through a robust clinical program and deep product pipeline. Abraxis 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.
Information in this news release was current as of the original release date.