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Eisai to Launch Insomnia Treatment Lunesta(R) in Japan

April 23, 2012

Tokyo, Apr 17, 2012 – (JCN Newswire) – Eisai Co., Ltd. announced today that it will launch the insomnia treatment Lunesta(R) (eszopiclone) in Japan on April 18.

Lunesta, originally discovered and developed by Sunovion Pharmaceuticals Inc. (“Sunovion”; formerly Sepracor Inc.; currently a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd.), is the first non-benzodiazepine type GABAA agonist to be launched in Japan in 12 years, and is believed to enhance GABA activity while exerting hypnotic and sedative effects. Results from clinical studies conducted in both Japan and overseas demonstrated that the agent is effective in treating those patients who have trouble falling asleep or wake up often during the night, two major symptoms of insomnia. Moreover, a distinctive feature of Lunesta is that patients do not experience clinically problematic issues such as dependency or carry-over effects, or develop a tolerance (experience diminished efficacy) with long-term use.

Marketed in the United States since April 2005, Lunesta was approved as the first insomnia treatment not to have restrictions placed on its length of use, and is widely used by individuals suffering from insomnia and is not typically taken by patients concomitantly with other insomnia treatments. Eisai has been pursuing the development of Lunesta since acquiring the exclusive rights to develop and market the product in Japan from Sunovion (at the time known as Sepracor). Lunesta received approval in Japan in January 2012, and was subsequently listed on the National Health Insurance (NHI) drug price list on April 17.

In a Phase II/III study (Study 126) conducted in Japan in patients with primary insomnia, patients treated with Lunesta demonstrated a statistically significantly improvement in Sleep Latency (SL)1), as measured by subjective evaluation, compared to placebo. Furthermore, Lunesta was shown to produce a statistically significant reduction (when measured against placebo) in Latency to Persistent Sleep (LPS), as objectively measured by an overnight polysomnography (PSG)2). The effects of Lunesta on measures of SL and LPS were the two co-primary endpoints of Study 126. The favorable safety profile of Lunesta was also confirmed in a long-term study (Study 150) in patients with various forms of insomnia, including elderly adults and adults with insomnia associated with psychological disorders.

Insomnia is a condition that has a repeated negative effect on a person’s ability to fall asleep, remain asleep or obtain quality of sleep despite having ample opportunity to sleep, and can interfere with everyday activities. In Japan, it is estimated that more than 20 million people suffer from some kind of sleep disorder, and this number expected to increase even further. By providing Lunesta as a new treatment for insomnia, Eisai seeks to make contributions to increase the benefits provided to patients.

For a product outline, further information on Lunesta and Japan clinical studies, and a product photograph please visit http://www.eisai.com/news/news201216.html.

1) Sleep latency (SL): the interval from “lights out” until sleep begins
2) Overnight polysomnography (PSG): a diagnostic tool that measures brain activity, eye movement and skeletal muscle activation to simultaneously record throughout the night the biophysical activity that occurs during sleep.

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 visit www.eisai.co.jp/index-e.html

Source: Eisai

Contact:

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

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