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FOREST LABS PHYSOSTIGMINE SR PHASE I STUDY

Executive Summary

FOREST LABS PHYSOSTIGMINE SR PHASE I STUDY for treatment of Alzheimer's disease is expected to begin "within the next month," a company spokesperson said. Forest is working on the project under an R&D partnership with PruBache, which is providing $ 6.7 mil. in financing in exchange for future royalties on sales. The drug will also enter in Phase II/III study at the University of California -- San Diego in April under a National Institute of Aging grant. Forest has been working on the physostigmine sustained release project for almost two years, according to the company's 1988 annual report. Commenting that "in some respects, the compound has been exceedingly difficult to work with," the company said it ran into difficulties making the controlled release product because of the drug's short half life, and because there was no existing technology for manufacturing the product. Forest expects full-scale clinicals on the compound to take at least two years, but says that if early results are promising "we would apply for earlier regulatory approval." The agent is in Phase III studies in the U.K. Controlled release physostigmine is one of a handful of drugs the National Institute on Aging (NIA) has targeted for study in Alzheimer's disease. NIA Director T. Franklin Williams testified at a March 20 hearing of the House Select Committee on Aging that the institute hopes to begin clinical trials in six to 12 months on several drugs,including slow release physostigmine, nimodipine (Miles' Nimotop), a tacrine (THA)/clonidine combination, nerve growth factor, huperzine, acetylcarnitine and high-dose thiamine. Miles is also studying nimodipine in Alzheimer's, with Phase III clinicals under way. Nimodipine was approved last December for treatment of subarachnoid hemorrhage from congenital intracranial aneurysms. A recent survey by the Pharmaceutical Manufacturers Association found that a total of 15 drugs are under investigation for treatment of Alzheimer's ("The Pink Sheet" Feb. 6, T&G-6). A multicenter clinical trial of the safety and efficacy of THA alone "should reach a point at which conclusions can be drawn late in 1989," Williams told the committee. According to NIA staff, results of the first 100 patients of the trial may be announced this summer. The trial is designed for 300 patients and 17 sites nationwide. Legislation to quadruple federal Alzheimer's research funding was introduced by Committee Chairman Roybal (D-Calif.) the day of the hearing. The "Alzheimer's Assistance, Research, and Education Act" is being cosponsored by Reps. Waxman (D-Calif.) and Stark (D-Calif.). The bill, HR 1490, would increase Alzheimer's research funding for NIH and the National Institute of Mental Health (NIMH) over a three year period to a total of $ 500 mil. by 1992. The current level of funding for Alzheimer's research is $ 120 mil. Under the measure, NIH would receive 80% of the proposed funding levels, while NIMH would receive 10%. The remaining 10% would be distributed between NIH and NIMH. Fifteen NIA Alzheimer's disease research centers would be funded under the measure, including three new centers. The bill would also provide $ 50 mil. in 1990, $ 100 mil. in 1991, and $ 125 mil. in 1992 to establish a joint federal and state program to assist victims of Alzehimer's disease and their families. All states and U.S. territories would be eligible for the program, which would make initial grants available for three years at an annual minimum funding rate of $ 250,000 and require matching funds from the states.

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