Eisai Submits MAA for New Formulation of ARICEPT (donepezil hydrochloride), Liquid Formulation in the European Union
Eisai Co., Ltd. (Headquarters: Tokyo, President: Haruo Naito) announced that on May 28, 2004, its U.K. subsidiary, Eisai Ltd. (Headquarters: London, Managing Director: Paul Hooper), submitted a Marketing Authorization Application (MAA) for a liquid formulation of ARICEPT to the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA will act as the Reference Member State for the European Union's (EU) Mutual Recognition procedure.
The new form of ARICEPT is designed to make administration easier for patients who have difficulty swallowing tablets and will contribute to improved compliance for more patients suffering from Alzheimer's disease. Eisai submitted a New Drug Application (NDA) for a liquid formulation in the U.S. in December 2003.
ARICEPT , an acetylcholinesterase inhibitor developed by Eisai Co., Ltd. in Japan, increases the concentration of acetylcholine, a neurotransmitter in the brain. ARICEPT is currently indicated for the treatment of mild to moderately severe Alzheimer's disease and is marketed in 76 countries worldwide. Eisai markets ARICEPT through copromotion with Pfizer in Japan, the United States, the United Kingdom, Germany, France and Spain, and markets solely in Asian countries.
Eisai Co., Ltd.
Corporate Communications Department
Phone 03-3817-5120 (Tokyo)