Eisai Submits a Marketing Authorization Application (MAA) for ARICEP(TM) (donepezil hydrochloride) - A New Drug Studied in the Treatmentof Alzheimer's Disease in the UK-
October 11, 1996 -- Eisai Co., Ltd. of Tokyo (President and CEO: Haruo Naito) today announced that Eisai Europe Ltd., an Eisai subsidiary, submitted an MAA to the UK Medicines Control Agency (MCA) for ARICEP(TM) (donepezil hydrochloride or E2020), its investigational new drug for mild to moderate Alzheimer disease on September 30.
ARICEP(TM) is a novel and selective acetylcholinesterase inhibitor synthesized by Eisai in Japan. The compound is being developed by Eisai in Japan, Europe and in the US. The US Food and Drug Administration (FDA) issued an approvable letter to Eisai America, Inc. for the ARICEP(TM) New Drug Application (NDA) which was submitted in late March of this year. ARICEP(TM) is in the Phase III clinical trial stage in Japan.
Alzheimer's disease affects the central nervous system. It is a progressive form of dementia with symptoms of memory loss, behavioral changes and eventual loss of language and motor skills. An estimated three million Europeans have Alzheimer's disease.
Eisai Co., Ltd. is a research-based human health care company which discovers, develops and markets products in more than 30 countries. Through its global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care systems. The company reported sales of $2.6 billion in 1995 with approximately 14 percent of sales spent for research and development.