Eisai Announces Japan Launch of Anticancer Agent Halaven

Tokyo, Japan, July 19, 2011 -- Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, "Eisai") today announced the launch of its novel anticancer agent Halaven in Japan for the treatment of inoperable or recurrent breast cancer.

Halaven is the first novel anticancer agent to be discovered and developed by the Eisai. Having simultaneously submitted marketing authorization applications to the regulatory authorities in Japan, the United States and the European Union (EU) in March 2010, the company first launched Halaven in the United States in November of the same year, and began marketing the agent in the United Kingdom, Germany and other European countries in April 2011.

Halaven is the first single-agent chemotherapy to demonstrate a statistically significant overall survival (OS) benefit in pretreated metastatic breast cancer patients. In a Phase III study (EMBRACE study) conducted overseas in pretreated patients with advanced or recurrent breast cancer, Halaven extended overall survival by 2.7 months compared to Treatment of Physician's Choice (TPC) (OS: 13.2 months vs. 10.5 months; Hazard Ratio[HR] 0.81; p=0.014). Additionally, a Phase II study (Study 221) conducted in Japan in patients with advanced or recurrent breast cancer patients previously treated with an anthracycline and a taxane showed that Halaven monotherapy demonstrated an excellent antitumor effect as well as a favorable tolerability profile.

Breast cancer remains one of the leading causes of cancer death among women, with approximately 60,000 patients in Japan being affected by the disease each year. Although advances are being made in the treatment of breast cancer in accordance with the development of new anticancer agents, there are still relatively few options available for those patients with inoperable or recurrent disease. The launch of Halaven in Japan means that it will now be possible for inoperable or recurrent breast cancer patients across country to have access to the agent.

Going forward, Eisai seeks to expand the value of Halaven® for breast cancer patients globally through the development of additional indications for refractory recurrent or metastatic breast cancer with fewer prior treatments and post-operative adjuvant therapy, as well as a new liposomal formulation. It also plans to develop Halaven as a treatment for other types of cancer such as non-small cell lung cancer, sarcoma, and prostate cancer, which along with the development of its existing pipeline products including MORAb-003 (farletuzumab), a monoclonal antibody targeting ovarian cancer, and E7080 (lenvatinib), a potential treatment for thyroid or endometrial cancer, will enhance the company's portfolio of Women's Oncology products.

In line with its human health care mission (hhc), Eisai's entire force of medical representatives (MRs) will work together to strengthen the company's activities in the Japanese oncology market, thereby contributing to fulfilling the needs of women and families throughout the country living with breast cancer and improving the quality of life.

Type Press Release

Date Released July 19, 2011

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