Takeda Pharmaceutical Company Limited (Takeda) announced that its wholly-owned subsidiary Takeda Global Research & Development (TGRD) Centre (Europe) Ltd. has decided to discontinue the development of ramelteon in Europe for the treatment of insomnia in order to best optimize Takeda’s resources for its research and development activities.
In September 2008, due to feedback received in May 2008 from the Committee for Medical Products for Human Use (CHMP) about the development requirements in Europe for this indication for ramelteon, TGRD Europe withdrew its Marketing Authorization Application (MAA) originally submitted to the European Medicines Agency (EMA) in March 2007.
After examining the possibility of filing a new MAA, which would include new clinical data generated since the original submission, Takeda decided not to re-submit the MAA. This decision took into consideration European requirements for approval of compounds for the treatment of insomnia, and Takeda’s long-term business strategy to optimize R&D efforts across its portfolio.
Ramelteon was approved by the United States (US) Food and Drug Administration in July 2005 and the Japanese Ministry of Health, Labour and Welfare in April 2010, and is currently available in these countries as ROZEREM. Takeda remains committed to ramelteon and believes it represents a valuable treatment option for patients. Moreover, Takeda is dedicated to conducting further research to evaluate the potential of ramelteon from every perspective.
Takeda will not revise the latest projected financial results for the fiscal 2011 in connection with the discontinuation of this programme in Europe.
Ramelteon works by selectively targeting two melatonin receptors in the brain, MT1 and MT2, which are located in the suprachiasmatic 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.
Based in London, England, Takeda Global Research & Development Centre (Europe) Ltd., (TGRD Europe), is a subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. TGRD Europe seeks to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, CNS, oncology and other conditions.
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 strive towards better health for patients worldwide through leading innovation in medicine.