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June 17, 2008
Takeda Pharmaceutical Company Limited
Takeda to Appeal EMEA Negative Opinion on ramelteon for the Treatment of Primary Insomnia
Osaka, Japan, June 17, 2008 – Takeda Pharmaceutical Company Limited (“Takeda”) announced today that its wholly owned subsidiary, Takeda Global Research & Development Centre (Europe) Ltd. (“TGRD(EU)”), has requested a re-examination of the opinion given by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).
This request is in response to the negative opinion of May 30, 2008, in which the CHMP recommended the refusal of the marketing authorization in the EU for ramelteon in the treatment of patients with primary insomnia, since the CHMP was concerned that the effectiveness of ramelteon had not been demonstrated, which was measured considering only one aspect of insomnia, the time to fall asleep.
The original Marketing Authorization Application (MAA) was submitted by TGRD(EU) in March 2007 and this request for re-examination was made in accordance with EMEA’s formal process whereby the sponsor of an MAA may request re-examination of the initial CHMP opinion.
Takeda remains convinced of the positive aspect of ramelteon, which induces the natural sleep for the treatment of patients with primary insomnia and looks forward to continuing working with the EMEA and the CHMP to bring this MAA to a positive outcome for patients in the European Union.
About ramelteon
Ramelteon works by selectively targeting two melatonin receptors in the brain, MT1 and MT2, which are located in the uprachiasmatic nucleus, the body’s ‘master clock’. By acting on these receptors, the body’s sleep-wake cycle is regulated and the physiological sleep is promoted.
Ramelteon, marketed as ROZEREMTM in the United States, was approved by the US Food and Drug Administration in July 2005. It also has been filed as a New Drug Application with the Ministry of Health, Labour and Welfare in Japan.
About Takeda
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website,www.takeda.com.