FDA Accepts Aricept Patch (Donepezil Transdermal System) NDA for Review

WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Sep 17, 2010 - Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for the Aricept® Patch (donepezil transdermal system). Teikoku Pharma USA, Inc., a subsidiary of Teikoku Seiyaku Co., Ltd., and Eisai are seeking approval of the weekly Aricept Patch in the treatment of mild, moderate and severe stages of Alzheimer's disease.

Teikoku Seiyaku and Eisai Co., Ltd. announced in early 2009 that the companies signed agreements regarding the development and marketing of the Aricept Patch in Japan, the U.S., and rest of world. If approved in the U.S., Eisai Inc. will hold marketing rights in the U.S. and will co-promote the Aricept Patch with Pfizer.

The acceptance of the NDA indicates that the FDA deems the company's submission to be sufficiently complete to review. The NDA was submitted to the FDA on June 30, 2010.

The Aricept Patch is a weekly transdermal patch that was developed to provide an alternative formulation for Alzheimer's patients. Eisai has a long-standing commitment to the Alzheimer's disease community and is dedicated to providing new treatment options.

About Aricept (donepezil HCl)

Aricept is the first and only prescription medication approved by the FDA for the treatment of all stages of AD—mild, moderate and severe dementia of the Alzheimer's type. It is not a cure for AD, but Aricept may help provide symptomatic benefits for some patients. Aricept may work differently for each person. For those who respond, symptoms may improve, they may stabilize, or they may progress more slowly than without Aricept. Aricept is currently available in 5 mg tablet, 10 mg tablet and 23 mg tablet, as well as an orally disintegrating tablet (5 mg and 10 mg). Aricept is co-promoted in the United States by Eisai Inc. and Pfizer Inc.

IMPORTANT SAFETY INFORMATION

ARICEPT 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.

People at risk for certain heart conditions should tell their doctor before starting ARICEPT because they may experience fainting. People with serious lung conditions and difficulty breathing, bladder problems or seizures should tell their doctor before using ARICEPT. ARICEPT 23 mg is associated with weight loss. Check with the doctor if this is a concern. Inform the doctor if the patient needs surgery requiring anesthesia while taking ARICEPT.

Some people may have nausea, diarrhea, difficulty sleeping, vomiting or muscle cramps. Incidence of nausea and vomiting were markedly greater in patients taking ARICEPT 23 mg/day versus patients taking ARICEPT 10 mg/day. Some people may feel tired or may have loss of appetite. If they persist, please talk to the doctor.

For Full Prescribing and Patient Information, please visit www.eisai.com.

About Eisai Inc.

Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion. Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd.

Eisai has a global product creation organization that includes U.S.-based R&D facilities in Maryland, Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com.

About Eisai Co., Ltd.

Eisai Co., Ltd. is a research-based human health care (hhc) 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 healthcare system. Eisai employs approximately 11,000 employees worldwide.

About Teikoku

Teikoku Pharma USA, Inc., a wholly-owned subsidiary of Teikoku Seiyaku Co., Ltd. that is a leading supplier of the topical analgesic transdermal patch, Lidoderm, in the world, is a specialty pharmaceutical company that develops and manufactures enhanced pharmaceutical products with its transdermal drug delivery technology. Teikoku focuses its efforts on two therapeutic areas: chronic and acute pain, and the central nervous system (CNS). The company is very pleased to explore a new field of CNS with the systemic transdermal patch. Teikoku's commitment is to expand transdermal technology for the benefit of patients and partners. For more information, please visit www.teikokuusa.com.

 

Contact: Eisai Inc.
Media Inquiries
Judee Shuler, 201-746-2241
or
Investor Inquiries
David Melin, 908-255-6378

 

 

Posted: September 2010


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