Eisai Announces Positive Results of U.S. Phase III Clinical Trials for Drug Studied in the Treatment of Alzheimer's Disease
March 26, 1996 (EST) -- Eisai Co., Ltd. of Tokyo today announced the results of a Phase III clinical trial which demonstrate that its investigational new drug, ARICEPT(TM)(donepezil hydrochloride), improves cognition and daily functioning of patients with mild to moderately severe Alzheimer's disease. The results are being presented today by Eisai America at the 48th annual meeting of the American Academy of Neurology in San Francisco. Eisai confirmed that submission of an ARICEPT(TM)New Drug Application (NDA) to the US Food and Drug Administration (FDA) by Eisai America will occur soon.
The double-blind placebo-controlled trial included 472 patients and lasted 30 weeks. Patients treated once daily with ARICEPT(TM)in the study experienced improvement in their Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) rating, whereas placebo-treated patients' ADAS-cog scores deteriorated. Improvement in daily functioning was also observed in independent physician and caregiver global impressions ratings using the Clinician's Interviewed-based impression of Change, incorporating caregiver input (CIBIC-Plus). The ARICEPT(TM) results achieved the highest level of statistical significance ever reported in any trial of an Alzheimer's drug.
"We believe the Phase III results will change the future treatment of Alzheimer's disease." said Sharon Rogers, Ph.D., Vice President of Clinical Research for Eisai America. ARICEPT(TM)could represent the first well-tolerated treatment for this important unmet medical need."
"We hope ARICEPT(TM)will be the first drug treatment that is practical for most patients with mild to moderately severe symptoms," commented Lawrence T. Friedhoff, M.D., Ph.D., Senior Vice President for Research and Development at Eisai America.
Eisai America reported that ARICEPT(TM)was well tolerated over the course of the trial. Side effects reported were mainly gastrointestinal, usually mild and transient, lasting an average of one or two days. There was no evidence of significant adverse effects on physical or laboratory values.
"The safety profile for ARICEPT(TM) is promising because it was so well tolerated," said Dr. Rachelle Doody, assistant professor at Baylor College of Medicine and an investigator in the Phase III trial. "The vast majority of patients completed the study successfully. The completion rate at our center was over 96 percent."
ARICEPT(TM) is a novel and selective acetylcholinesterase inhibitor synthesized by Eisai in Japan. The compound is being 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 eventual 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 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).
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 percent 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.