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Executive Summary

WARNER-LAMBERT INTENDS TO CHARGE FOR COGNEX UNDER TREATMENT IND following the first six weeks of therapy, according to information sent out to physicians by the company. Cognex (tacrine) will be provided free of charge for the first six weeks to Alzheimer's patients enrolled in the Treatment IND program. After that, patients will be charged $100 per month. Warner-Lambert has sent letters to approximately 1,500 neurologists, geriatricians, and psychiatrists announcing the availability of Cognex under a Treatment IND program okayed by FDA on Dec. 2 ("The Pink Sheet" Dec. 9, p. 7). Each of the physicians is being asked to recruit 10-15 patients with mild to moderate Alzheimer's disease. Warner-Lambert has said that it hopes to enroll a total of 15,000 patients and to collect data on about 3,000 at the maximum Cognex dose ("The Pink Sheet" Jan. 13, T&G- 3). The cost to patients who have completed the first stage of Cognex dosing will be between $3-$4 per day plus about $20 per week for a weekly blood test. Warner-Lambert plans to distribute Cognex directly to physicians through parcel delivery services. Physicians may order the product by calling Warner-Lambert directly via an 800 number. The Treatment IND protocol calls for patients to receive 40 mg/day for six weeks, 80 mg/day for six weeks and 120 mg/day for twelve weeks. The treatment protocol excludes patients who have liver dysfunction or gastroduodenal ulcers, who are hypersensitive to cholinomimetics, or who have been previously terminated from a Cognex trial. The company expects to begin enrolling patients in the beginning of March. Meanwhile, Warner-Lambert will continue to recruit patients in a 500-person higher-dose (up to 160 mg/day), double-blind, placebo-controlled efficacy trial. Warner-Lambert said enrollment in that study is progressing at a fast rate. The study, to be conducted at 33 sites in the U.S., is expected to be completed in early 1993. Hoechst-Roussel Pharmaceuticals, which has been projecting imminent filing of a Treatment IND for its Alzheimer's treatment Mentane (velnacrine) for the past six months, reportedly will not submit a treatment protocol to FDA for another three to four months. On Feb. 19, Baker Cummins Pharmaceuticals parent Ivax announced that the firm is beginning double-blind, placebo- controlled Phase II studies in the U.S. of a new Alzheimer's drug called Alzene. The trials will be conducted at the New York University Medical Center and the Miami Jewish Home and Hospital for the Aged. Alzene is believed to improve neuronal cell membrane fluidity by modifying the fatty acid composition of the neuronal cell membrane, Ivax said. The agent has been studied in Israel at Bar Ilan University, where the company reports that nearly 70% of patients taking the drug "experienced significant reductions in the signs and symptoms related to the disease." However, the duration of those studies is reportedly only several weeks long.

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