EISAI RECEIVES APPROVAL TO MARKET INSOMNIA TREATMENT LUNESTA® IN JAPAN

January 18, 2012 - Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced 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... Eisai's Press Release -

EISAI : JAPANESE CLINICAL TRIALS CONFIRM SAFETY AND EFFICACY OF INSOMNIA TREATMENT SEP-190

September 15, 2010 - EISAI PLANS TO SUBMIT MAA IN FISCAL 2010 - Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced that clinical studies conducted in Japanese patients with insomnia have confirmed the efficacy and favorable safety profile of SEP-190 (generic name: eszopiclone). Based on these results, Eisai plans to submit a marketing authorization application in fiscal 2010 seeking approval of the agent to the Japan’s Ministry of Health, Labour and Welfare.

A Phase II/III clinical study (Study 126) with SEP-190 was conducted in Japan in patients with primary insomnia, in addition to a Phase III study (Study 150) in patients with insomnia. Study 126 evaluated the efficacy of SEP-190 in 72 adult patients with primary insomnia through an overnight polysomnography (PSG) and subjective evaluation. Results showed that, compared with placebo, SEP-190 statistically significantly reduced latency to persistent sleep (LPS), as measured by a PSG, and sleep latency (SL), as measured by subjective evaluation, the study’s two primary outcome measures. Study 150 evaluated the long term safety of SEP-190 in 325 adult and elderly patients with chronic insomnia caused by a variety of factors. Results of the study confirmed that the agent has a favorable safety profile.
SEP-190 is a non-benzodiazepine type GABAA agonist (non-benzodiazepine sedative hypnotic) discovered and developed by Sepracor Inc.,... Eisai's Press Release -