Eisai Submits NDA for ARICEPT(TM) (donepezil hydrochloride), A New Drug Studied in the Treatment of Alzheimer's Disease
March 29, 1996 (EST) -- Eisai Co., Ltd. of Tokyo today announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ARICEPT(TM), its investigational new drug for the treatment of Alzheimer's disease. The ARICEPT(TM) NDA was submitted by Eisai America, Inc., a US subsidiary of Eisai Co., Ltd.
Eisai and Pfizer Inc. announced in November, 1994 the formation of a strategic alliance for the promotion of ARICEPT(TM) and development of new treatments for Alzheimer's disease and other cognitive disorders. ARICEPT(TM) is the lead compound in this alliance and will be promoted by Eisai and Pfizer sales forces when cleared for US marketing. Under terms of this alliance, Eisai will book all US sales of ARICEPT(TM).
Phase III clinical trial results presented earlier this week by Eisai America, Inc. at the annual American Academy of Neurology meeting showed that administration of ARICEPT(TM) (donepezil hydrochloride) once daily produced statistically significant improvement in cognition and daily functioning for patients with mild to moderately severe Alzheimer's disease.
Eisai America scientists reported that ARICEPT(TM) was well tolerated over the course of the study. Side effects reported were mainly gastrointestinal and were usually mild and transient, lasting only one or two days. There was no evidence of significant adverse effects on physical or laboratory values.
"We believe ARICEPT(TM) can be an important advance in the fight against Alzheimer's disease. It may offer a treatment that is practical for most patients with mild to moderately severe symptoms," said Lawrence T. Friedhoff, M.D., Ph.D., Senior Vice President for Research and Development at Eisai America. Sharon Rogers, Ph.D., Vice President of Clinical Research at Eisai America, further commented that, "We believe ARICEPT(TM) is important for the future treatment of Alzheimer's disease."
The NDA for ARICEPT(TM) contains extensive data from clinical trials including patients who have been on the drug under clinical supervision for over three years.
"Today's NDA submission represents many years of dedicated effort by personnel in the US and Japan." said Mr. Haruo Naito, President and Chief Executive Officer of Eisai Co., Ltd. "We sincerely hope that ARICEPT(TM) will be an important treatment for Alzheimer's patients and contribute to the advancement of human health care worldwide."
ARICEPT(TM) is a novel and selective acetylcholinesterase inhibitor synthesized by Eisai in Japan. The compound is being clinically developed by Eisai in worldwide clinical trials. It is in the last stages of Phase III clinical trials in Europe, Canada, Australia, New Zealand and South Africa and will enter Phase III trials in Japan later this year.
Alzheimer's disease affects the central nervous system. It is a progressive form of dementia with symptoms of memory loss, behavioral changes and, eventually, loss of language and motor skills. According to published reports from the Alzheimer's Association, an estimated four million Americans 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 over $2.9 billion in fiscal year 1994 with approximately 14 % of sales spent for research and development.
Pfizer Inc. is a research-based health care company with global operations. The company reported sales of more than $10 billion for 1995, and spent more than $1.4 billion on research and development last year.