Takeda Pharmaceuticals North America Shares Early Stage Data on ramelteon, formerly known as TAK-375

SAN FRANCISCO, October 20, 2003 – Results from pre-clinical trials of ramelteon (formerly known as TAK-375), under development by Takeda Pharmaceuticals North America (TPNA) for transient and chronic insomnia, were presented today at the American Neurological Association’s (ANA) annual meeting in San Francisco.

These studies examined the effects of various combinations of ramelteon, exogenous melatonin, and benzodiazepine, opiate, and ML-2 receptor agonists on sleeping behavior, learning abilities, memory, motor coordination and abuse potential in different animal models.

“We are excited about the continued development of ramelteon because in our pre-clinical studies, the compound has shown no affinity for either GABA or opiate receptors,” said Stephen Sainati, M.D., Ph.D., vice president of Clinical Research, TPNA, Lincolnshire, Ill. “Phase 3 trials are underway to further evaluate the safety and efficacy of this novel compound for the treatment of both transient and chronic insomnia.”

About Ramelteon (TAK 375)
Ramelteon is a compound in a new class of drugs known as selective ML-1 receptor agonists. Targeting ML-1 receptor agonists represents a new investigative approach to the treatment of insomnia. Ramelteon specifically targets the brain’s ML-1 receptors located in the suprachiasmatic nucleus (SCN), a part of the hypothalamus. The SCN is known as the body’s “master clock” because it regulates circadian (sleep-wake) cycles, playing an important role in the sleep cycle.

Pre-clinical trials have shown ramelteon to have significantly higher selectivity, affinity and potency for the ML-1 receptor than melatonin. Melatonin is produced naturally in the body and regulates sleep and wake cycles and activates multiple receptors in the brain and peripheral tissues.

About Takeda Pharmaceuticals North America
Based in Lincolnshire, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Chemical Industries, Ltd. based 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 industry's leaders worldwide, Takeda is committed to strive toward better health for individuals and progress in medicine by developing superior pharmaceutical products.

Contacts:

Jocelyn Gerst
Takeda Pharmaceuticals North America
847-383-3696

-or-

Michelle Toscas
Edelman
312-233-1265

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