Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, "Eisai") announced today that it received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) on January 18, 2012 to market Lunesta® (eszopiclone), a product the company has been developing in Japan, as a treatment for insomnia.

Lunesta, originally discovered and developed by Sunovion Pharmaceuticals Inc. ("Sunovion"; formerly Sepracor Inc., "Sepracor"; a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd.), has been marketed in the United States since April 2005. The agent was approved as the first insomnia treatment not to have restrictions on its length of use, and is widely used by individuals suffering from insomnia. Eisai has been pursuing the development of Lunesta since acquiring the exclusive rights to develop and market it in Japan from Sunovion (at the time known as Sepracor) in July 2007. The company submitted a marketing authorization application to the MHLW in November 2010.

Lunesta is a non-benzodiazepine type GABAA agonist that is believed to enhance GABA activity while exerting hypnotic and sedative effects. Results from clinical studies conducted in Japan and overseas demonstrated that the agent is effective in those patients who have trouble falling asleep or wake up often during the night, two major symptoms of insomnia. 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.

In a Phase II/III study (Study 126) conducted in Japan in patients with primary insomnia, Lunesta was shown to statistically significantly improve Sleep Latency (SL)1) as measured against placebo. In addition, Lunesta was shown in Study 126 to cause a statistically significant (when measured against placebo) reduction in latency to persistent sleep (LPS), as objectively measured by an overnight polysomnography (PSG)2). The measurement of the impact of Lunesta on 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, and can interfere with everyday activities despite having ample opportunity to sleep. In Japan, it is estimated that more than 20 million people suffer

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