Eisai Launches Anticancer Agent Lenvima in the United States

First Country in the World to Gain Access to New Treatment Option
TOKYO, Mar 2, 2015 - (ACN Newswire) - Eisai Co., Ltd. announced today that its U.S. subsidiary Eisai Inc. has launched its in-house developed novel anticancer agent Lenvima (lenvatinib mesylate) as a treatment for locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer in the United States on February 26, 2015. The United States is the first country in the world where the agent has been launched.

Discovered at Eisai's Tsukuba Research Laboratories and developed in-house, Lenvima is an orally administered molecular targeted agent that selectively inhibits the activities of several different molecules including VEGFR, FGFR, RET, KIT and PDGFR. In particular, the agent simultaneously inhibits VEGFR, FGFR and also RET which are especially involved in tumor angiogenesis and proliferation of thyroid cancer. Furthermore, Lenvima has been confirmed through X-ray crystal structural analysis to demonstrate a new binding mode (Type V) to VEGFR2, and exhibits rapid and potent inhibition of kinase activity, according to kinetic analysis1. In a Phase III placebo controlled study (SELECT study), Lenvima demonstrated a statistically significant improvement in progression-free survival compared to placebo as well as response rate. The five most common Lenvima treatment-related adverse events of any grade were hypertension, diarrhea, fatigue or asthenia, decreased appetite, and weight loss. Lenvima was approved in the United States by the U.S. Food and Drug Administration (FDA) on February 13, 2015, based on the FDA's priority review system.

Although treatment is possible for most types of thyroid cancer, there are few treatment options available once thyroid cancer has progressed, therefore it remains a disease with significant unmet medical needs. The number of patients newly diagnosed with thyroid cancer in 2012 in the United States was estimated to be approximately 52,000.

Currently the agent is undergoing regulatory review in Japan and the EU, as well as Switzerland, South Korea, Canada, Singapore, Russia, Australia and Brazil, and Lenvima was also granted accelerated assessment in the EU. Eisai will continue to file applications seeking regulatory approval for the agent in countries around the world, and the company will market the agent in those countries where approval has been received. Furthermore, Eisai is conducting a global Phase III trial of Lenvima in hepatocellular carcinoma as well as Phase II studies of Lenvima in several other tumor types such as renal cell carcinoma and non-small cell lung cancer.

In addition to providing Lenvima as a new treatment option for thyroid cancer, Eisai is committed to exploring the potential clinical benefits of Lenvima in order to further contribute to address the diverse needs of, as well as increase the benefits provided to, patients with cancer, and their families.

About Eisai

Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visitwww.eisai.com.

Contact:
Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120

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