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¾«¶«Ó°Òµ. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that its partner Teikoku Pharma USA, Inc. (Headquarters: California, President & CEO Masahisa Kitagawa, “Teikoku USA”) has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) concerning the New Drug Application (NDA) it submitted for a transdermal patch formulation of Aricept® (donepezil hydrochloride).

The FDA issues a Complete Response Letter to indicate the review cycle of an application is complete and there are still requirements to be fulfilled. The requirements of FDA are mainly formulation and usage ¾«¶«Ó°Òµand Teikoku USA will work with FDA to assess the Complete Response Letter and determine next steps.

The Aricept® transdermal patch formulation was developed in the United States by Teikoku USA based on license agreements concluded between ¾«¶«Ó°Òµand its parent company Teikoku Seiyaku Co., Ltd. (Headquarters: Kagawa, President & CEO: Misako Fujioka) in February 2009. In June 2010, Teikoku USA submitted an NDA to the FDA seeking approval to use Aricept® transdermal patch in the treatment of mild, moderate and severe stages of Alzheimer's disease.

¾«¶«Ó°Òµhas been working proactively to enhance value for Alzheimer's disease patients by adding new indications and formulations of Aricept®. In August 2010, the Company launched a new higher dose Aricept® 23 mg tablet in the Unites States as an additional dosing option for patients with moderate-to-severe Alzheimer's, adding to its already established line-up comprising Aricept® 5 mg and 10 mg tablets and Aricept® 5 mg and 10 mg orally disintegrating tablets.