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Executive Summary

WARNER-LAMBERT's COGNEX TO RECEIVE THIRD ADVISORY COMMITTEE REVIEW at a March 18 meeting of FDA's Peripheral & Central Nervous System Drugs Advisory Committee, the agency announced in the Feb. 16 Federal Register. Warner-Lambert will present the committee with results from its 500-patient double-blind, placebo-controlled 30-week trial using Cognex (tacrine) at higher doses (up to 160 mg) than those used in most previous trials. Warner-Lambert believes that the trial, which began enrolling patients in October 1991, "will answer any questions raised" at the committee's March 1991 and July 1991 reviews of the drug. At the March 15, 1991 meeting, the advisory committee decided it could not recommend approval for Cognex based on the two pivotal studies submitted by Warner-Lambert ("The Pink Sheet" March 18, 1991, p. 2). Four months later the committee recommended that FDA should ask the company to initiate additional controlled trials of Cognex before granting a Treatment IND for the drug. The Treatment IND began in December 1991 and has enrolled 5,500 patients receiving doses of up to 120 mg. The results of a 12-week double-blind, placebo-controlled study published in the Nov. 11, 1992 issue of the Journal of the American Medical Association may also be discussed by the committee. That study, which involved 468 mildly to moderately impaired Alzheimer's patients taking up to 80 mg per day of Cognex, found that 51% of patients receiving the highest tacrine dose achieved a four-point improvement on the cognitive component of the Alzheimer's Disease Assessment Scale ("The Pink Sheet" Nov. 30, 1992, T&G-2). A seven point or greater improvement was achieved by 27% of patients. Cognex is vying with Hoechst-Roussel's Mentane (velnacrine) and Forest's Synapton (physostigmine) to become the first approved acetylcholinesterase inhibitor for Alzheimer's. In November 1992, the peripheral & CNS committee voted against a Treatment IND for Mentane until further studies on efficacy and the incidence of agranulocytosis associated with the drug could be conducted ("The Pink Sheet" Nov. 9, 1992, p. 5). Forest, which has maintained that Synapton has a better side effect profile than Cognex or Mentane, plans to file for a Treatment IND for the drug in the first quarter of 1993 ("The Pink Sheet" Nov. 30, 1992, T&G-2). On March 19, the advisory committee will discuss the safety and efficacy of Betaseron (recombinant interferon beta) from Berlex for the treatment of multiple sclerosis. Schering A.G. subsidiary Berlex licenses Betaseron marketing rights from codeveloper Chiron, which will manufacture the product. On March 20, the advisory committee will discuss Burroughs Wellcome's anticonvulsant Lamictal (lamotrigine) for the treatment of epilepsy. In December, the company told analysts that the add-on therapy for partial seizures has a less complicated dosing regimen than current therapies ("The Pink Sheet" Dec. 7, 1992, T&G-3). The advisory committee will convene from 8 a.m. to 5 p.m. on March 18 and 19 in conference rooms D and E of FDA's Parklawn building and from 8:30 a.m. to 5 p.m. on March 20 at the Holiday Inn Crowne Plaza in Rockville, Md.

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