Forest Alzheimer's drug development

Forest will submit NDA for memantine "around the end of 2001," but the company appears to view approval based on the two completed pivotal trials to be a long shot. FDA has agreed that the U.S. trial of memantine appears to support efficacy of the drug, but the agency "indicated that a second study performed in Europe would likely need to be reviewed by an advisory committee to determine whether the specific endpoints utilized were adequate to qualify it as a second study demonstrating efficacy," Forest said. The company is initiating additional Phase III studies in both mild-to-moderate and moderate-to-severe Alzheimer's in case additional evidence of efficacy is required. Forest hopes to launch the product "by the second half of 2003"; a decision by the advisory committee that the European study is sufficient would allow for an earlier launch