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Orally Disintegrating Tablet Version of Donepezil Gains FDA Nod

October 21, 2004 -- Eisai Global Clinical Development announced today that the U.S. Food and Drug Administration has approved ARICEPT® ODT™ (donepezil HCl) Orally Disintegrating Tablets, the first such medication approved by the FDA to treat the symptoms of mild to moderate Alzheimer's disease.

ARICEPT ODT will be available in the U.S. in 5 mg and 10 mg tablets in blister packaging and will provide the same dosage strength of drug as ARICEPT tablets. It will be available in the second quarter of 2005 and will be co-promoted by Eisai Inc. and Pfizer Inc. A similar dosage form was approved for use in Japan in February 2004. Additionally, an application was filed with the regulatory authorities in Europe in December 2003. Eisai developed the technology for ARICEPT ODT.

The new dosage form was designed to make administration easier for patients. Studies have shown that patients with Alzheimer's disease may develop difficulty with swallowing.

"ARICEPT ODT demonstrates Eisai and Pfizer's commitment to scientific innovations that may improve the lives of Alzheimer's patients and their caregivers," said Mindell Seidlin, M.D., president, Eisai Global Clinical Development.

Information About ARICEPT® (donepezil HCl tablets) Treatment in Alzheimer's Disease
While there is no cure for Alzheimer's disease, medical treatments are available to manage symptoms of the disease. Once-a-day prescription ARICEPT® is indicated for mild to moderate Alzheimer's disease. ARICEPT® is co-promoted in the United States by Eisai Inc. and Pfizer Inc.

ARICEPT® is well tolerated but may not be for everyone. People at risk for stomach ulcers or who take certain other medicines should tell their doctors because serious stomach problems, such as bleeding, may get worse.

Some people may have nausea, diarrhea, not sleep well or vomit. Some people may have muscle cramps, feel very tired, or may not want to eat. In studies, these side effects were usually mild and went away over time. Some people who take ARICEPT® may experience fainting.

For full prescribing information on ARICEPT®, please visit http://www.aricept.com/.

Source: Eisai

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