Press Releases

March 20, 2007

Takeda Pharmaceutical Company Limited

Takeda Submits a European Marketing Authorization Application for Ramelteon, a New Treatment for Insomnia

OSAKA, JAPAN, March 20, 2007 --- Takeda Pharmaceutical Company Limited (Takeda)
today announced that, Takeda Global Research & Development Centre (Europe), Ltd.
submitted a marketing authorization application for insomnia medication, ramelteon,
to the European Medicines Agency (EMEA) through the centralized procedure. The application is for the treatment of primary insomnia.

Ramelteon works by selectively targeting two melatonin receptors in the brain, MT1 and MT2. These receptors are located in the suprachiasmatic nucleus, the body's 'master clock', which regulates circadian (24-hour) rhythms, including the sleep-wake cycle. By acting on these receptors, the body's sleep-wake cycle is regulated and the physiological sleep is promoted. This mechanism of action of ramelteon is different from existing insomnia treatments, which work by depressing the central nervous system (CNS).

"Since the discovery of the ramelteon in 1996, our company has been committed to exploring its effects in patients who have difficulty sleeping," said Masaomi Miyamoto, Ph.D., general manager of Pharmaceutical Development Division of Takeda.
"Ramelteon has a novel mechanism of action, the first specific MT1 and MT2 receptor agonist, which we believe will offer a new treatment option for people with insomnia. We look forward to bringing this next-generation treatment to Europe."

Insomnia is a serious condition that affects the daily life of around 20% of the European population. There is an unmet need for effective treatment options with fewer side-effects which also have a low propensity for dependence.

Ramelteon was approved by the U.S. Food and Drug Administration (FDA) in July 2005 and is being marketed by Takeda Pharmaceuticals North America, Inc. under the trade name ROZEREMェ (the European brand name for ramelteon is to be confirmed) has shown no evidence of abuse and dependence in clinical trials. More than one million prescriptions have been written for ramelteon in the US to date.

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About Ramelteon

Ramelteon has been studied in 58 clinical trials in Europe, Japan, Canada and the United States. The EMEA filing was based on data collected from an extensive clinical research programme, including clinical studies with 8,100 patients, aged 18 to 93.

About Insomnia

An estimated 20% of Europeans suffer from insomnia on a regular basis or experience daytime consequences impairing quality of life or daily function. Insomnia is characterized by difficulty falling asleep, difficulty staying asleep, or poor quality sleep, leading to impairment of next-day functioning. Insomnia has been linked to a variety of health problems, including obesity, diabetes, hypertension, heart disease and depression.

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