Eisai Submits Application to FDA for ARICEPT® for Treatment of Severe Alzheimer's Disease

(2005-09-11)

Eisai Co, Ltd and Eisai Inc announced that on their behalf, Eisai Medical Research Inc. (Headquarters: Ridgefield Park, President Mindell Seidlin, MD) has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for ARICEPT® (donepezil HCl tablets) for treatment of severe Alzheimer's disease (AD). ARICEPT, which is co-promoted in the United States by Eisai Inc. and Pfizer Inc, is currently approved for treatment of mild to moderate AD.

Our goal to provide ARICEPT to people with severe Alzheimer's disease is consistent with Eisai's human health care mission to improve the lives of patients and their families," said Lonnel Coats, president and COO, Eisai Inc.

The August 31 submission is based on data from a six-month, multi-center, randomized, double-blind, placebo-controlled clinical trial conducted in approximately 250 nursing home patients with severe AD. In the pivotal study, patients with severe AD (Mini Mental State Examination scores 1-10) treated with ARICEPT had a statistically significant improvement compared to those taking placebo on both primary measures of efficacy: the Severe Impairment Battery (SIB scale) and the Modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS ADL severe scale). The SIB measures cognition in a more severe population. The ADCS ADL measures patient function and ability to conduct activities of daily living.

Treatment with ARICEPT® (donepezil HCl tablets) was generally well tolerated. The most common adverse events in ARICEPT-treated patients reported at more than twice the rate of placebo-treated patients were diarrhea and hallucinations. The rate of discontinuation for adverse events was greater in the ARICEPT-treated patients than in the placebo-treated patients (15.6 % vs 6.7%).

AD is a progressive brain disease that gradually destroys a person's memory and ability to learn, reason, make judgments, communicate and carry out daily activities. AD affects 4.5 million Americans. One in 10 persons over age 65 has AD, and nearly half of those over 85 have it. The levels of acetylcholine (ACh), a brain chemical involved in memory and thinking, decrease in people with AD. ARICEPT is believed to work by inhibiting the breakdown of ACh, thereby increasing available levels of this chemical in the brain.

Information About ARICEPT Treatment in Alzheimer's disease

While there is no cure for Alzheimer's disease, medical treatments are available to help manage symptoms of the disease. Once-a-day prescription ARICEPT is indicated for mild to moderate Alzheimer's disease.

In a progressively degenerative disease such as Alzheimer's, improvement, stabilization or a less-than-expected decline over time is considered a positive response to treatment. These types of responses have been observed in patients treated with ARICEPT in clinical trials for Alzheimer's disease. Individual responses to treatment vary, and some patients may not respond.

ARICEPT is well tolerated but may not be for everyone. 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. 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 who take ARICEPT may experience fainting.

ARICEPT is the number one prescribed Alzheimer's disease therapy worldwide, with more than 1 billion patient days of ARICEPT therapy. More than 1.7 million people in the United States alone have begun ARICEPT therapy.

ARICEPT® (donepezil HCl tablets) was discovered and developed and is manufactured and distributed by Eisai.

For more information about managing Alzheimer's disease and about ARICEPT, see accompanying full prescribing information or call (888) 999-9616 or visit http://www.aricept.com.

About Eisai Co., Ltd.

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.

About Eisai Medical Research Inc.

Eisai Medical Research Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd. Eisai Medical Research Inc. was established to focus solely on clinical research and to expedite clinical drug development of new chemical entities and of new indications for marketed products.

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 approximately $2 billion in fiscal year 2004 (year ended March 31, 2005).

About Pfizer Inc

Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines for humans and animals and many of the world's best-known consumer brands.

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