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Executive Summary

WARNER-LAMBERT's COGNEX EXPANDED AVAILABILITY VIA TREATMENT IND will be proposed by the company at FDA's Peripheral and Central Nervous System Drugs Advisory Committee on July 15. Warner-Lambert said it will present for review by the committee "a protocol for expanded access" of the Alzheimer's drug Cognex (tacrine) "through a Treatment IND" mechanism that will employ a large number of patients to collect safety data. Warner-Lambert has discussed the expanded availability protocol with FDA but will await the committee's yea or nay recommendation before formally filing for Treatment IND status, the company said. There currently are a few hundred patients receiving Cognex cognition therapy through ongoing clinical trials in the U.S., Canada and France. A positive recommendation of the proposed protocol would allow Warner-Lambert to provide tacrine to a large Alzheimer's patient population while FDA's review of the NDA continues. However, the request to distribute the product under a Treatment IND indicates that FDA approval may not be imminent. Expanded availability could yield data to provide more complete information concerning Cognex' potential for liver toxicities beyond the two small pivotal trials included in the NDA. Warner-Lambert said it has not decided whether it will ask for payment under the proposed protocol. The eventual market is considerable: there are an estimated 4 mil. Alzheimer's patients in the U.S., and tacrine would be a chronic treatment for the degenerative disease. FDA announced the advisory committee meeting in the July 3 Federal Register. The Committee reviewed Cognex for the first time on March 15 but was unable to recommend approval of the drug due to unresolved efficacy questions from the two pivotal clinical trials presented at the meeting ("The Pink Sheet" March 25, p. 4). The Federal Register notice states that the committee will discuss "a number of issues affecting the availability and clinical testing" of tacrine. Warner-Lambert's decision to propose expanded availability for Cognex follows a series of discussions between the company and FDA in the aftermath of the March 15 advisory committee meeting. The agency raised the issue of expanded availability in a March 22 letter to Warner-Lambert in which FDA proposed additional studies as "one of a number of steps" the company could take to clarify the status of Cognex. FDA Neuropharmacological Drugs Division Director Paul Leber, MD, suggested in the letter that a "possible design" for expanded access would be "a good-sized, relatively low-tech, parallel design study of several doses of tacrine with provision for occasional blood level sampling." Warner-Lambert submitted supplemental data and other data requested by the advisory committee on April 4. There are no outstanding issues from that data package, the company said. The open advisory committee meeting is scheduled to be held at the Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, Maryland. It is scheduled to last from 8 a.m. to 5 p.m. The March 15 advisory committee meeting turned into a 14-hour marathon.

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