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WARNER-LAMBERT ISSUES STATEMENT ON TACRINE STUDY IN NEW ENGLAND JOURNAL

WARNER-LAMBERT ISSUES STATEMENT ON TACRINE STUDY IN NEW ENGLAND JOURNAL
 /ADVANCE/ MORRIS PLAINS, N.J., Oct. 27 /PRNewswire/ Warner-Lambert Company (NYSE: WLA) today issued the following statement on the results of the previously reported clinical trial involving its experimental Alzheimer's disease drug Cognex (tacrine or THA) published in Thursday's New England Journal of Medicine.
 This clinical study (970-1) was conducted at 16 trial centers across the U.S. between 1987 and 1990. The results -- the subject of an article in this week's New England Journal of Medicine -- were presented in full at an open meeting of the FDA's Peripheral and Central Nervous System Drug's Advisory Committee on March 15, 1991.
 The results demonstrate statistical significance on The Alzheimer's Disease Assessment Scale, one of two primary outcome measures. The average size of the treatment effect is comparable to a five-month delay in the progression of the disease. However, the second primary outcome measure, the Clinician's Global Impression of Change (CGIC), failed to reach statistical significance.
 The study was designed in collaboration with the FDA and National Institute on Aging. However, now that the data from this study have been fully analyzed, it is widely believed that the enrichment phase and elaborate crossover design contributed to the equivocal results.
 At a subsequent advisory committee meeting in July 1991, these data were again presented and discussed. The advisory committee recommended that Warner-Lambert conduct a simple, parallel-design study of Cognex at higher doses and over a longer treatment period, believing that doses as high as 120 to 160 mg. per day might be needed to provide sufficient evidence of Cognex's efficacy. In response to that recommendation, Warner-Lambert began a second large, multicenter, double-blind, placebo- controlled, parallel-group study of 30 weeks duration (970-61). This study will be completed early in the first quarter of 1993.
 At the July, 1991 advisory committee meeting, Warner-Lambert requested permission to conduct a treatment IND program. In the case of Cognex, the results of the 970-1 trials proved promising enough to allow the initiation of the Cognex treatment IND. In December, the FDA authorized the program, which could allow as many as 15,000 U.S. patients to receive the drug at doses as high as 120 mg. Currently, some 1,700 physicians and more than 4,000 patients are participating in the program. The purpose of the Cognex treatment IND is to expand access to desperately ill patients -- for whom no approved therapy exists -- and to gather additional safety information. In total, more than 7,000 patients have participated in tacrine studies over the past six years.
 Even before the advisory committee meetings, Warner-Lambert had initiated a simple, parallel-design study (970-26) of Cognex. The results of this study have been reported to the FDA and were presented at the Third International Conference on Alzheimer's Disease and Related Disorders on July 17, 1992, in Padua, Italy. These findings, for the first time, demonstrated statistically significant results favoring Cognex over placebo in both primary outcome measures -- the ADAS- Cognitive (ADAS-Cog) and the investigator rated Global Impressions of Change (CGIC). These data are currently in press at a leading medical journal.
 Warner-Lambert is confident that the ongoing studies will provide definitive answers and solidify the position of Cognex in the treatment of Alzheimer's disease.
 -0- 10/28/92/1800
 /CONTACT: Peter Wolf, 201-540-6696, or Nancy Fitzsimmons, 201-540-2145, both of Warner-Lambert Company/
 (WLA) CO: Warner-Lambert Company ST: New Jersey IN: MTC SU:


AH -- NY087 -- 5464 10/27/92 13:40 EST
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Date:Oct 27, 1992
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