News Releases

Sep. 29, 2005

Dainippon and Eisai Signed Licensing Agreement
for A Potential New Treatment for Diabetic Neuropathy

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, a potential new treatment for 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 typical diabetic complication, by suppressing the accumulation of sorbitol within cells through strongly inhibiting aldose reductase. It is estimated that the population suffering from 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 potential new treatment to its product line-up in the neurology arena, one of its franchise therapeutic areas, would help the company fulfill its human health care mission by providing benefits to patients suffering from diabetic neuropathy.

In close coordination with Dainippon Pharmaceutical, Eisai will continue the development currently being conducted by Dainippon Pharmaceutical and proceed with subsequent trials, seeking early application for approval in the United States and other countries.

[The glossary is attached for reference.]


Dainippon Pharmaceutical Co., Ltd.
Public Relations Dept.
Doshomachi 2-6-8, Chuo-ku, Osaka

Eisai Co., Ltd.
Corporate Communications Dept.
Koishikawa 4-6-10, Bunkyo-ku, Tokyo

[Note to editors]

- What is diabetic neuropathy?
One of three major diabetic complications along with retinopathy and nephropathy. Patients with diabetes can develop diabetic neuropathy at high rates (approximately 40%), accompanied by symptoms such as numbness and pain in the hands, arms, feet and legs and postural hypotension, which can result in a worsening of patientsf quality of life. 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, thus it is important for patients to be diagnosed and treated in the early stages.