WOODCLIFF LAKE, N.J. - (Business Wire) Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted priority review status to the company’s New Drug Application (NDA) for the investigational agent eribulin mesylate (“eribulin,” also known as E7389). Eisai is seeking FDA approval for eribulin in the treatment of patients with locally advanced or metastatic breast cancer previously treated with at least two chemotherapy regimens, including an anthracycline and a taxane.
FDA grants priority review status to those drugs that if approved, have the potential to provide, in the treatment, prevention, or diagnosis of a disease, one of the following: (1) safe and effective therapy where no satisfactory alternative therapy exists; or (2) a significant improvement compared to marketed products. The goal for completing a review of an NDA with priority review status is six months compared with the standard 10-month time frame.
Eisai submitted simultaneous regulatory applications for the approval of eribulin in the U.S., Japan and the European Union (EU) on March 30, 2010. The company also has submitted regulatory applications for approval to health authorities in Switzerland and Singapore.
Eisai defines oncology as a therapeutic area of focus and is committed to developing novel anti-cancer agents and treatments for supportive care. With these efforts, Eisai seeks to further address the diversified needs of patients and families affected by cancer as well as healthcare professionals.
About Eribulin
Eribulin mesylate (E7389) is an investigational agent being evaluated as a potential treatment for locally advanced or metastatic breast cancer. A non-taxane, microtubule dynamics inhibitor, eribulin is a synthetic analog of halichondrin B, which is derived from a natural product isolated from the marine sponge Halichondria okadai.
About Advanced or Metastatic Breast Cancer
Advanced or metastatic breast cancer occurs when a malignant tumor in the breast spreads from its original site to other parts of the body. Approximately 50 percent of women worldwide initially diagnosed with breast cancer are expected to develop recurrent or metastatic disease within 15 years of their first diagnosis. Only one in five women with metastatic breast cancer survives longer than five years. In the U.S., an estimated 155,000 women are currently living with metastatic breast cancer, and that number is projected to increase to 162,000 by 2011.
Eisai Inc.
Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Maryland, Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com.
Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs approximately 11,000 employees worldwide.
Media Inquiries Judee Shuler Eisai Inc. 201-746-2241 (office) or Investor Inquiries Dave Melin Eisai Inc. 908-255-6378 (office)
