FDA Accepts Aricept® Patch (Donepezil Transdermal System) NDA for Review
San Jose, California, September 17, 2010—Teikoku Pharma USA, Inc., an international specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for a new weekly transdermal patch of Aricept®, a leading medication for the treatment of Alzheimer’s disease.
The company developed the weekly Aricept® patch based on a license agreement executed between Teikoku Pharma USA, Inc. and Eisai Co., Ltd. (Eisai) in February 2009. The acceptance of the NDA indicates that the FDA deems the company’s submission to be sufficient to review. The NDA was submitted to the FDA by Teikoku Pharma USA, Inc. on June 30, 2010. If approved, Eisai’s subsidiary, Eisai Inc., will hold marketing rights in the U.S.
The Aricept® transdermal patch formulation employs a unique drug delivery system, making it the world’s first weekly transdermal patch for the treatment of Alzheimer’s disease. It was developed to provide a potential new treatment option to Alzheimer’s disease patients who have trouble swallowing, as well as to reduce the burden on caregivers and family members who administer medication to patients.
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 looks forward to exploring a new field of CNS with the systemic transdermal patch. Teikoku is committed to applying its transdermal technology for the benefit of patients and partners.
Eisai Co., Ltd. is a research-based human health care (hhc) company that discovered and developed Aricept® (Donepezil HCl tablets), the number-one prescribed Alzheimer’s medication worldwide. It is sold in approximately 75 countries. In the United States, the product is co-promoted by Eisai Inc. and Pfizer Inc. and distributed by Eisai Inc. Aricept® continues to be studied for various potential new indications and formulations. Eisai focuses its efforts on three therapeutic areas: integrative neuroscience, integrative oncology, and vascular and immunology reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system.