Current Status of the Development Programs of New Indications and Formulations for Aricept(R) for Enhancing Pat...( TOKYO and WOODCLIFF LAKE N.J. July 2 ...),Health

TOKYO and WOODCLIFF LAKE, N.J., July 2 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, "Eisai") and Eisai Corporation of North America (Headquarters: Woodcliff Lake, NJ, Chairman and CEO Hajime Shimizu) are currently focusing on three clinical development programs for the company's major product Aricept(R) (donepezil hydrochloride tablets) to further contribute to patients with Alzheimer's disease. As progress in those programs has been made, Eisai announces the status as follows:

1. Sustained Release Tablets

Eisai has completed a Phase III study of Aricept 23 mg sustained release (SR) in patients with moderate to severe Alzheimer's disease. Aricept 23 mg SR is being developed to increase clinical benefits while maintaining a favorable safety profile compared to currently marketed Aricept 10 mg immediate release.

Based on the preliminary review of the data from this Phase III study, Eisai plans to submit a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in August or September 2009.

2. Pediatric Use

Eisai filed a Proposed Pediatric Study Request (PPSR), an application that proposes a rationale and study design for pediatric studies, with the U.S. FDA in February 2009 to evaluate the clinical benefits of donepezil in children with attention impairment following cancer treatment. Eisai received a notice from the U.S. FDA that there were insufficient grounds to issue a Written Request to obtain pediatric exclusivity. Eisai plans to complete the ongoing studies to provide important information on this therapeutic approach for an underserved patient population currently with limited treatment options.

3. Transdermal Patch Formulation

Clinical trials of a once-a-week transdermal patch formulation of donepezil, which include a bioequivalence study compared to the currently markete
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