SOURCE: Eisai Co., Ltd.

September 29, 2005 08:00 ET

Reminder - Eisai Signs In-Licensing Agreement With Dainippon Pharmaceutical for Potential New Treatment for Diabetic Neuropathy

TOKYO -- (MARKET WIRE) -- September 29, 2005 -- Dainippon Pharmaceutical Co., Ltd (Headquarters: Osaka, President: Kenjiro Miyatake) and Eisai Co., Ltd. (Headquarters: Tokyo, President: Haruo Naito) today signed an exclusive licensing agreement for AS-3201 (generic name: ranirestat), an investigational drug for the treatment of diabetic neuropathy that was discovered and is being developed by Dainippon Pharmaceutical. Under the agreement, Eisai will assume the exclusive rights to further develop, manufacture and market this compound worldwide outside Japan, while Dainippon Pharmaceutical will retain the rights to Japan and to co-promote the compound with Eisai in major countries.

AS-3201 is designed to improve the symptoms of diabetic neuropathy, a common complication of diabetes, by suppressing the accumulation of sorbitol within cells through strongly inhibiting aldose reductase. It is estimated that the population with diabetic neuropathy is 3.6 million in the United States, 2.6 million in the five major European countries and 1.7 million in Japan.

Dainippon Pharmaceutical has been developing AS-3201 on its own as a global strategic product, aiming at an early application for approval. The company is currently conducting Phase III clinical trials in the United States and Canada, and Phase II trials in Japan with Kyorin Pharmaceutical Co., Ltd.

Eisai expects that adding this new treatment to its product line-up in the neurology arena, one of its franchise therapeutic areas, will help the company fulfill its human health care mission by providing benefits to patients with diabetic neuropathy.

In close coordination with Dainippon Pharmaceutical, Eisai will continue the development currently being conducted by Dainippon Pharmaceutical and plans to submit marketing applications in the United States and other countries.

Diabetic neuropathy is one of three major diabetic complications along with retinopathy and nephropathy. Patients with diabetes can develop neuropathies at high rates (approximately 40%). Symptoms of diabetic neuropathy include numbness and pain in the hands, arms, feet and legs, and dizziness and faintness due to postural hypotension.

If left untreated, diabetic neuropathy can lead to gangrene in the foot or leg, which may require amputation in severe cases. There are no effective treatments for advanced diabetic neuropathy outside of Japan, thus it is important for patients to be diagnosed and treated in the early stages.

About Eisai

Eisai Co., Ltd. is a research-based human health care company that discovers, develops and markets products in more than 30 countries. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs more than 7,700 people worldwide. Established in the United States in 1995, Eisai Inc. began marketing its first product in 1997 and has rapidly grown to become an integrated pharmaceutical business with sales of approximately $2 billion in fiscal year 2004 (year ended March 31, 2005).

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