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COGNEX ALZHEIMER’s DRUG HAS "1A" FAST-TRACK RATING AT FDA

Executive Summary

COGNEX ALZHEIMER's DRUG HAS "1A" FAST-TRACK RATING AT FDA, Warner-Lambert Chairman Joseph Williams disclosed during Q-&-A at a meeting with securities analysts in New York City on Oct. 18. In response to an inquiry on the status of Cognex (THA or tacrine), Williams reported that the compound had received a 1A classification from FDA during the week of Oct. 15. The 1A rating designates Cognex as a new chemical entity representing a significant advance over existing therapies. The classification of a compound as 1A usually implies that it will receive special attention from FDA. Warner-Lambert has been predicting a rapid review for Cognex since an interim analysis of the drug's Phase III clinical trials was completed in late July 1989 ("The Pink Sheet" July 24, 1989, "In Brief"). Principal investigator Kenneth Davis, MD, Mt. Sinai Hospital, stated that the results of this study, which involved 100 patients in 16 Alzheimer's centers, indicated that "continuation of study [of Cognex] is warranted," despite signs of a high incidence of liver toxicity. The company filed the NDA for the product on June 4 of this year based on data from some 200 patients. The NDA is supplemented by data from U.K.-based Shire Pharmaceutical's three month double-blind, placebo-controlled crossover trial. Warner-Lambert acquired the data in April. Cognex may get to an advisory committee within the next two or three months, the company believes. FDA's Peripheral and Central Nervous System Drugs Advisory Committee already has met to discuss Cognex twice. The last meeting was a closed session held immediately before the release of the interim analysis in July 1989.
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