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°®¶¹´«Ã½. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that its U.K. subsidiary Eisai Europe Limited has entered into an agreement with PharmaSwiss S.A. (Headquarters: Switzerland), a Division of Valeant Pharmaceuticals International, Inc. (Headquarters: Canada), to promote and distribute the company's novel anticancer agent Halaven® (eribulin mesylate) in a number of Central and Eastern European (CEE) countries.

Discovered and developed by Eisai, Halaven is the first single-agent chemotherapy to demonstrate a statistically significant overall survival benefit in patients with pretreated metastatic breast cancer. The agent was approved by the European Commission in March 2011 for the treatment of patients with locally advanced or metastatic breast cancer whose disease has progressed after at least two chemotherapeutic regimens for advanced disease, including an anthracycline and a taxane, and is now available in 11 European countries.

Under the terms of the agreement, PharmaSwiss will promote and distribute Halaven in Bulgaria, Estonia, Latvia, Lithuania, Poland, Romania, Hungary and Slovenia. PharmaSwiss is the largest distributor in CEE, offering regional expertise in such functions as regulatory, compliance, sales, marketing and distribution. This new partnership will enable Eisai to deliver its innovative, novel drug Halaven much faster to patients in these CEE countries in which the company has not established locally based sales offices.

Eisai is committed to increasing access to its medicines through the implementation of various new partnership-based business models to improve affordability, availability and adoption, and to making contributions to increase the benefits provided to an even greater number of patients and families worldwide.

[ Please refer to the following notes for further information on PharmaSwiss, Halaven and metastatic breast cancer ]

PharmaSwiss, a Division of Valeant Pharmaceuticals International, is a branded generics and over-the-counter (OTC) pharmaceutical company based in Zug, Switzerland, with operations in countries throughout Central and Eastern Europe, including Poland, Hungary, the Czech Republic and Serbia. The company also has operations in Greece and Israel. In addition, Pharma Swiss is an existing partner with several large pharmaceutical and biotech companies, offering regional expertise in such functions as regulatory, compliance, sales, marketing and distribution.

Halaven, a non-taxane, microtubule dynamics inhibitor with a novel mechanism of action, belongs to a class of antineoplastic agents, the halichondrins, which are natural products isolated from the marine sponge Halichondria okadai. It is believed to work by inhibiting the growth phase of microtubule dynamics without affecting the shortening phase and sequestering tubulin into nonproductive aggregates. Halaven is approved for the treatment of patients with locally advanced or metastatic breast cancer who have been previously treated with at least two chemotherapeutic regimens, including an anthracycline and a taxane.
As part of efforts to expand the range of approved indications, Eisai is currently conducting late stage clinical trials investigating the potential of Halaven as a single-agent therapy in the treatment of other types of cancer such as breast cancer with fewer prior treatments, non-small cell lung cancer, sarcoma, and prostate cancer.

Worldwide, more than one million women a year are diagnosed with breast cancer, including 421,000 women in Europe. Approximately 30 percent of women initially diagnosed with earlier stages of breast cancer eventually go on to develop recurrent or metastatic disease, and while around 9 out of 10 of women diagnosed with early stage breast cancer survive beyond five years, this drops to around 1 in 10 among women first diagnosed with metastatic breast cancer. Most metastatic breast cancer patients have a limited survival time of approximately 18 to 24 months.