Takeda Pharmaceutical Company Ltd announced 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.

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.