Eisai Receives FDA Marketing Clearance for ARICEPT(TM)(donepezil hydrochloride), A New Treatment for Alzheimer's Disease - Improves Cognition and Patient Function; is Well Tolerated -
New York (November 25, 1996) -- Eisai Co., Ltd. of Tokyo (TSE/4523) and Pfizer Inc (NYSE/Pfizer) today announced that Eisai America, Inc. has received marketing clearance from the U.S. Food and Drug Administration for ARICEPT(TM) (donepezil hydrochloride) or E2020, a new drug for the symptomatic treatment of mild to moderate Alzheimer's disease. ARICEPT(TM) is effective in improving cognition and patient function in people with mild to moderate Alzheimer's disease.
"Eisai's dedication to the needs of patients and their families and our commitment to human health care and Alzheimer's disease research have fostered the development of this important new therapy," said Haruo Naito, president and chief executive officer of Eisai. According to William C. Steere, Jr., chairman and chief executive officer of Pfizer, "Alzheimer's disease is a family tragedy. ARICEPT(TM) will benefit patients and families alike by improving or maintaining patient function, which in turn may help ease the burden for caregivers and help maintain personal dignity."
Controlled clinical trials in over 900 patients demonstrated that more than 80 percent of patients taking ARICEPT(TM) either improved or exhibited no further deterioration in tests of cognition over the course of the studies. In an assessment of patient function, which includes general function, cognition, behavior and activities of daily living, clinicians rated approximately 2 times as many patients on ARICEPT(TM) as improved in comparison to placebo after 24 weeks of treatment.
"While improvement in cognition obviously represents the most desirable outcome, due to the degenerative nature of Alzheimer's disease, patients who did not decline in cognition while taking ARICEPT(TM) are also considered to have received significant benefit from treatment," said David S. Geldmacher, M.D., clinical director, Alzheimer Center, University Hospitals of Cleveland and Case Western Reserve University.
ARICEPT(TM) is a new reversible inhibitor of the enzyme acetylcholinesterase. Acetylcholinesterase is an enzyme which breaks down the neurotransmitter acetylcholine ARICEPT(TM) may allow a greater concentration of acetylcholine in the brain, there by improving cholinergic function. Acetylcholine, associated with memory and learning, is in short supply in patients with Alzheimer's disease.
"ARICEPT(TM) is the first effective and well tolerated once daily treatment for patients with mild to moderate Alzheimer's disease," said Lawrence T. Friedhoff, M.D., Ph.D., executive vice president for research and development at Eisai America.
"ARICEPT(TM) represents a significant step forward in addressing the therapeutic needs of the Alzheimer's disease community," noted Sharon L. Rogers, Ph.D., vice president for research and development at Eisai America. "This therapy will help to change the approach to the management of Alzheimer's disease."
ARICEPT(TM) Efficacy and Tolerability
The efficacy and tolerability of ARICEPT(TM) was established by two double-blind, placebo controlled Phase III clinical trials. In the trials, patients diagnosed with mild to moderate Alzheimer's disease were randomized to receive single daily doses of placebo or either 5 mg once daily or 10 mg once daily of ARICEPT(TM) for 12 or 24 weeks.
Two tests were used to measure the effectiveness of treatment with ARICEPT(TM). The first, the Alzheimer's Disease Assessment Sale - Cognitive Subscale (ADAS-cog), a psychometric scale, was used to measure cognition. The Clinician's Interview Based Impression of Change, or ClBlC-Plus, was used to assess change in patient function through comprehensive interviews with patients and caregivers. Results achieved a high level of statistical significance comparing ARICEPT(TM) to placebo.
ARICEPT(TM) is well tolerated. Approximately 83 percent of patients enrolled in controlled trials completed their scheduled participation. The most common signs and symptoms leading to discontinuation were nausea, diarrhea and vomiting occurring in 3 percent or fewer patients. The incidence of side effects was low and when side effects did occur, they were usually mild and transient. Furthermore, there is no need for liver function monitoring with ARICEPT(TM).
The initial dose of 5 mg is a clinically proven effective dose. However, a comparison of group mean data suggests that some patients may receive even greater benefit from increasing to 10 mg after four to six weeks on 5 mg.
ARICEPT(TM) will be available shortly by prescription in 5 mg and 10 mg tablets with once-daily dose administration.
Eisai Co., Ltd. and Pfizer Inc
In November 1994, Eisai Co., Ltd. and Pfizer Inc announced 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 co-promoted by Eisai Inc. and Pfizer sales forces in the U.S.
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 system. The company reported sales of $2.6 billion in 1995 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 expects to spend about $1.7 billion on research and development this year.
ARICEPT(TM) is a trademark of Eisai Co., Ltd.