Healthcare Industry News:  dementia 

Biopharmaceuticals Neurology FDA

 News Release - October 13, 2006

U.S. Food and Drug Administration Approves ARICEPT(R) for Treatment of Severe Alzheimer's Disease

First and Only Treatment Approved for the Full Spectrum of Alzheimer's Disease - Mild, Moderate and Severe

TEANECK, N.J. and NEW YORK, Oct. 13 (HSMN NewsFeed) -- Eisai and Pfizer Inc announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for ARICEPTŪ (donepezil HCl tablets) for treatment of severe Alzheimer's disease (AD). The application was submitted by Eisai Medical Research Inc. (Headquarters: Ridgefield Park, President Mindell Seidlin, MD) on behalf of Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO Haruo Naito) and Eisai Inc. (Headquarters: Teaneck, NJ, Chairman and CEO Hajime Shimizu).

With this approval, ARICEPT becomes the first and only prescription medication to treat the full spectrum of AD (mild, moderate and severe). ARICEPT, which is co-promoted in the United States by Eisai Inc. and Pfizer Inc, has been approved in the United States since 1996 for treatment of mild to moderate AD.

"For the first time ever, the millions of people affected by Alzheimer's disease and the families, caregivers and healthcare professionals who care for them now have a once-daily therapy, Aricept, to treat the symptoms of every stage of this disease," said Sharon Richardson, Ph.D., senior director, Medical Affairs, Eisai Inc. "This milestone exemplifies Eisai's and Pfizer's commitment to improving the lives of families living with Alzheimer's disease and advancing the scientific understanding of this devastating form of dementia."

The approval was based on results of a pivotal six-month, multi-center, randomized, double-blind, placebo-controlled clinical trial involving 248 Swedish nursing home patients with severe AD (Mini Mental State Exam scores 1-10). The study, the first to evaluate ARICEPTŪ (donepezil HCl tablets) 10 mg once-daily exclusively in patients with severe AD, was published March 2006 in The Lancet. Patients treated with ARICEPT had statistically significant benefit compared to those taking placebo in both primary efficacy measures: the Severe Impairment Battery for cognition and the Modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease for function/activities of daily living.

Treatment with ARICEPT was generally well tolerated. The most commonly reported adverse events in ARICEPT-treated patients that occurred at a frequency of at least 5 percent and at twice the rate of placebo-treated patients, were diarrhea, anorexia, vomiting, nausea and bruising.

"Aricept has been proven effective and well tolerated to help treat the symptoms of mild to moderate Alzheimer's disease," said Rachelle Doody, M.D., Ph.D., professor of Neurology, Baylor College of Medicine in Houston. "With this approval, we now know that Aricept can provide benefit in memory, thinking and activities of daily living in people with severe Alzheimer's disease."

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 as many as half of those over 85 have it. About 20 percent of people with Alzheimer's disease are in the severe stage.

Information About ARICEPT Treatment in Alzheimer's Disease

While there is no cure for Alzheimer's disease, ARICEPT can help slow down the progression of symptoms, including memory loss. Once-a-day prescription ARICEPT is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate and severe Alzheimer's disease. ARICEPT 5 mg and 10 mg are approved for the treatment of mild to moderate Alzheimer's disease. ARICEPT 10 mg (after four to six weeks at 5mg) is approved for the treatment of severe Alzheimer's disease. ARICEPT is an acetylcholinesterase inhibitor and is believed to work by inhibiting the breakdown of acetylcholine, thereby increasing available levels of this chemical in the brain. There is an established association between the loss of acetylcholine, a brain chemical involved in memory and thinking, and Alzheimer's disease.

ARICEPTŪ (donepezil HCl tablets) 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 who take ARICEPT may experience fainting. Some people may have nausea, vomiting, diarrhea, bruising, or not sleep well. Some people may have muscle cramps or loss of appetite or may feel tired. In studies these were mild and temporary.

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 the number one prescribed Alzheimer's disease therapy worldwide, with more than 3 billion patient days of ARICEPT therapy. Nearly 2.3 million people in the United States alone have taken ARICEPT.

ARICEPT is co-promoted in the United States by Eisai Inc. and Pfizer Inc, which are dedicated to advances in Alzheimer's therapy.

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 throughout the world. 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 9,000 people worldwide.

About Eisai Inc.

Eisai Inc., a U.S. pharmaceutical subsidiary of Eisai Co., Ltd., focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care. 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 $2.2 billion in fiscal year 2005 (year ended March 31, 2006).

Eisai Inc. employs more than 1,300 people at its headquarters in Teaneck, NJ, at its state-of-the-art pharmaceutical production and formulation research and development facility in Research Triangle Park, NC, and in the field. Between 1998 and 2005, Eisai Inc. moved up rapidly in the rankings (based on retail sales) of U.S. pharmaceutical companies from No. 44 to No. 19. For more information about Eisai, please visit http://www.eisai.com.

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 on clinical research and to expedite clinical drug development of new molecular entities and of new indications for marketed products.

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.


Source: Eisai

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