Forest expects to submit an NDA for the Alzheimer's drug memantine in June, the company told analysts at the Deutsche Bank healthcare conference in Baltimore May 7

Forest expects to submit an NDA for the Alzheimer's drug memantine in June, the company told analysts at the Deutsche Bank healthcare conference in Baltimore May 7

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