Eisai Announces Canadian Approval of its Anticancer Agent Halaven

Tokyo, Japan, December 15, 2011 -- Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, "Eisai") announced today that its Canadian pharmaceutical sales subsidiary Eisai Limited ("Eisai Canada") has received approval from Health Canada for Halaven (eribulin mesylate), a novel anticancer agent discovered and developed by Eisai, for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane administered in either the adjuvant or metastatic setting. Eisai Canada will move forward with preparations for the launch of Halaven with a view to commencing sales of the product during the fiscal year ending March 31, 2012.

Halaven is the first single-agent chemotherapy to demonstrate a statistically significant overall survival (OS) benefit in previously treated metastatic breast cancer patients. Eisai simultaneously submitted marketing authorization applications seeking approval of Halaven to the regulatory authorities in Japan, the European Union (EU) and the United States in March 2010. As of December 2011, the agent is approved in 35 countries worldwide including Canada, the most recent approval, the United States, EU member countries, Japan and Switzerland.

In Canada, like many European countries and the United States, breast cancer is one of the most frequently diagnosed cancers among women, with over 23,000 new cases expected annually. An estimated 5,000 Canadians die each year as a result of breast cancer.

Eisai Canada was established in April 2010 as Eisai's first pharmaceutical sales base in the Canadian market. Having commenced fully-fledged operations earlier this year, the company has already launched the antiepileptic agent Banzel as well as the chemotherapeutic implant Gliadel Wafer for the treatment of certain malignant brain tumors. From next year onwards, Eisai Canada also plans to submit New Drug Submissions (NDSs) for the AMPA receptor antagonist perampanel (generic name) and a range of other additional new products in the fields of oncology and neurology, Eisai's defined areas of global therapeutic focus, thereby expanding its Canadian product portfolio.

With the approval of Halaven in Canada, Eisai will strive to make the product available in Canada as soon as possible and make further contributions to increase the benefits provided to patients and their families as its seeks to fulfill its mission as a human health care (hhc) company.

Type Press Release

Date Released December 15, 2011

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