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Takeda Submits New Drug Application for Ramelteon, an Investigational Sleep Drug

September 24, 2004

Compound from a new class of drugs represents the first novel mechanism of action (MOA) to be developed in 35 years in the area of insomnia

Lincolnshire, Ill., September 24, 2004 – Takeda Global Research & Development Center announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) to market ramelteon (TAK-375), its investigational drug for insomnia. Ramelteon belongs to a new class of prescription drugs with the first novel mechanism of action to be developed in 35 years in the area of sleep research. Ramelteon specifically targets the MT1 and MT2 receptors in the brain, which are believed to be critical in the regulation of the body’s sleep-wake cycle.

“The NDA submission for ramelteon is a significant milestone for Takeda,” said John Yates, M.D., president of Takeda Global Research & Development. “Since the discovery of the ramelteon compound by Takeda researchers in 1997, our company has been dedicated to exploring its effects in patients who have difficulty sleeping. This submission is the result of the hard work and dedication of our many employees and partner investigators.”

The submission is based on data collected from Takeda’s extensive clinical research program, including recently completed Phase 3 studies. The clinical research program included more than 4,200 patients, ages 18 to 93, who received single daily doses of ramelteon for various periods of time up to one year. Ramelteon has been studied in clinical trials in the U.S., Japan and Europe. Seven placebo-controlled trials were conducted to determine the efficacy of ramelteon in the treatment of insomnia, and results from 42 ramelteon trials are summarized in the company’s safety database. The company’s clinical research database also includes interim data from an ongoing, year-long safety study.

In addition, Takeda has conducted animal and human studies to further assess ramelteon’s safety attributes. These studies specifically evaluate whether or not treatment with ramelteon has the risk of drug dependence and abuse associated with other FDA-approved drugs for insomnia. Results from the animal abuse liability and addiction studies will be presented at the U.S. Psychiatric and Mental Health Congress later this year.

“We’re excited about the continued development of ramelteon. Insomnia is a serious condition that affects the daily lives of millions of Americans, and we believe that there is a significant need for new treatment options that may benefit patients,” said Stephen Sainati, M.D., Ph.D., vice president of Clinical Research at Takeda.

About Ramelteon
Ramelteon offers a completely new mechanism of action for insomnia, specifically targeting two receptors in the brain, MT1 and MT2 .
The MT1 and MT2 receptors are located in the brain’s suprachiasmatic nuclei (SCN). The SCN is known as the body’s “master clock” because it regulates the 24-hour sleep-wake cycle. The MT1 receptor is thought to regulate sleepiness, while the MT2 receptor is thought to help the body shift easily between phases of day and night. Together, it is believed these receptors serve as key mediators of sleep in humans, encouraging sleep onset.

Currently prescribed sleep agents and some investigational drugs work by targeting gamma-aminobutyric acid (GABA) receptors, which are located throughout the brain. In pre-clinical studies, ramelteon has shown no affinity for GABA or opiate receptors.

About Insomnia
An estimated 70 million people in the U.S. suffer from insomnia. According to the National Sleep Foundation, 61 percent of American adults have not been asked by a doctor how well they sleep, and only six percent of Americans have been diagnosed with insomnia. Further, only 50 percent of those diagnosed with insomnia receive treatment for their condition. Insomnia can be described as either transient, the inability to sleep well over a period of a few nights for fewer than four weeks, or chronic, the inability to fall asleep that lasts for more than one month.

Insomnia disturbs sleeping and waking hours and can be associated with marked impairments in quality of life and the ability to function effectively during the day. Recent research shows that chronic sleep loss and untreated sleep disorders cost the U.S. $15 billion in health care expenses and $50 billion in lost productivity annually.

Additionally, frequent sleep problems in older Americans, if ignored, can complicate the treatment of other medical conditions, including arthritis, diabetes, heart disease and depression. When untreated, insomnia can lead to depression, impaired productivity, absenteeism from work, increased risk of accidents and decreased quality of family and social life.

About Takeda Pharmaceuticals North America
Based in Lincolnshire, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited (Osaka, Japan). Takeda is a research-based global pharmaceutical company. Through the Takeda Global Research & Development Center, Inc. the company has a robust pipeline with compounds in development for diabetes, sleep, cardiovascular disease and other conditions. As the largest pharmaceutical company in Japan and one of the industry’s leaders worldwide, Takeda is committed to strive toward better health for individuals and progress in medicine by developing superior pharmaceutical products. For company information, visit Takeda Pharmaceuticals North America’s Web site at www.tpna.com .

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