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FDA Approves Orally Disintegrating Tablet Formulation of ARICEPT(R) for the Treatment of Patients With Mild to Moderate Alzheimer's Disease

Posted on: Thursday, 21 October 2004, 14:00 CDT

RIDGEFIELD PARK, N.J., Oct. 21 /PRNewswire/ -- . Eisai Global Clinical Development announced today that the U.S. Food and Drug Administration has approved ARICEPT(R) ODT(TM) (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(R) (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(R) is indicated for mild to moderate Alzheimer's disease. ARICEPT(R) is co-promoted in the United States by Eisai Inc. and Pfizer Inc.

ARICEPT(R) 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(R) may experience fainting.

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

About Eisai Global Clinical Development

Eisai Global Clinical Development was formed in June 2004 by Eisai Co., Ltd. to enhance the speed and efficiency of Eisai's global drug development efforts. Eisai Co., Ltd. is a research-based human health care company that discovers, develops and markets products in more than 30 countries. Eisai Global Clinical Development combines the talent and resources of Eisai Medical Research in the United States and the R&D staff of Eisai Ltd. in the United Kingdom to create a seamless development team with a shared vision. Facilities operate in the United States and the United Kingdom.

About Eisai Inc.

Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd. Established in 1995, Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business with sales of more than $1.7 billion in fiscal year 2003 (year ending March 31, 2004).

Eisai Inc.

CONTACT: Judee Shuler of Eisai, +1-201-287-2241; or Becky Lauer ofManning Selvage & Lee, +1-212-468-4125, for Eisai Inc.

Web site: http://www.aricept.com/

Source: PRNewswire

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