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 -

Sunovion Pharmaceuticals Inc. : Company Name Change

October 12, 2010 - Sunovion Pharmaceuticals Inc. (Sunovion), formerly Sepracor Inc. (Sepracor), announced that it has formally changed its name. The change occurs on approximately the one year anniversary of the acquisition of Sepracor by Dainippon Sumitomo Pharma Co., Ltd. (DSP), an Osaka, Japan based pharmaceutical company. Sunovion integrates under one brand the distinct competencies of Sepracor and the former Dainippon Sumitomo Pharma America, Inc. (DSPA), the two U.S. operations of DSP.

“This is an exciting time for Sunovion Pharmaceuticals Inc. and we are poised to deliver on our vision to become a leading global pharmaceutical company known for scientifically-advanced products that improve the lives of patients”
“This is an exciting time for Sunovion Pharmaceuticals Inc. and we are poised to deliver on our vision to become a leading global pharmaceutical company known for scientifically-advanced products that improve the lives of patients,” said Mark Iwicki, President and Chief Operating Officer of Sunovion. “The meaning of Sunovion combines the strength of the sun with innovation and, for us, represents the start of a great new company. Launching our new corporate identity is a meaningful next step for our employees and partners who have contributed to our past success. We remain focused on our goal to grow our current brands and advance our pipeline candidates.”

In April 2010, DSPA, based in Fort Lee, N.J., merged into Sepracor consolidating DSP’s North American footprint in Marlborough, Mass. As Sunovion, the company will maintain corporate headquarters in Marlborough and critical R&D functions will continue in both Fort Lee and Marlborough. The company will maintain sales and marketing efforts for leading central nervous system and respiratory brands including LUNESTA.. [PDF] Sunovion Pharmaceuticals' Press Release - [PDF] Dainippon Sumitomo Pharma's Press Release -