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 -

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 -

Lupin : FDA tentative approval for Eszopiclone tablets

March 20, 2010 - Pharma Major, Lupin Limited announced that its U.S subsidiary, Lupin Pharmaceuticals, Inc. (LPI) has received tentative approval for the Company’s Abbreviated New Drug Application (ANDA) for Eszopiclone tablets, 1 mg, 2 mg and 3 mg from the U.S. Food and Drug Administration (USFDA).

Lupin’s Eszopiclone tablets are the AB-rated generic equivalent of Sepracor’s LUNESTA® tablets, indicated for the treatment of insomnia. The brand product had annual sales of approximately $761 million for the twelve months ended December 2009, based on IMS Health sales data... Lupin Pharmaceuticals' Press Release -

Sepracor : LUNESTA(R) Next-Day Function and Discontinuation Data from a Long-Term 12-Week Study in Elderly Patients Presented at ECNP

Sept. 3, 2008 - Sepracor Inc. (Nasdaq: SEPR) announced the presentation of LUNESTA(R) brand eszopiclone Phase IV study data at the 21st European College of Neuropsychopharmacology (ECNP) Congress in Barcelona. The poster presentations reflected results from a 12-week, double-blind, randomized safety and efficacy study of 388 elderly patients (65-85 years of age) who were administered either LUNESTA 2 mg or placebo nightly. Upon conclusion of the 12-week, double-blind treatment period, all patients received single-blind placebo for two weeks to assess rebound and withdrawal effects. This two-week, single-blind period was then followed by an additional two-week evaluation period in which patients received neither LUNESTA nor placebo in order to assess the durability of the response.

A 12-Week Study of Eszopiclone in Elderly Out-patients With Primary Insomnia: Effects of Treatment Discontinuation

In this study, sleep latency, wake time after sleep onset and total sleep time were all statistically significantly... Sepracor's Press Release -

Sepracor : LUNESTA Study of Patients with Insomnia and Co-Morbid Generalized Anxiety Disorder (GAD) Published in Archives of General Psychiatry

May 12, 2008--Sepracor Inc. (Nasdaq: SEPR) announced the publication of a study of LUNESTA tablets in patients with insomnia and co-morbid generalized anxiety disorder (GAD) in the May issue of the Archives of General Psychiatry. This 595-patient study examined the safety and efficacy of LUNESTA co-administered with escitalopram oxalate, which is commonly used in the treatment of anxiety, versus co-administration of escitalopram and placebo in patients with insomnia and co-existing GAD. The study also evaluated the potential for co-administration of LUNESTA to increase the magnitude and/or accelerate the anxiolytic response versus escitalopram alone... Sepracor's Press Release -