Forest Laboratories Inc. (Active Pharmaceutical Ingredient Watch).(Alzheimer's disease drug application with FDA voluntarily withdrawn after Phase III trial)(Government Activity)(Product Development)(Brief Article)

Chemical Market Reporter, September, 2002

FOREST Laboratories Inc. has voluntarily withdrawn its new drug application (NDA) with the Food and Drug Administra-tion (FDA) to market memantine for moderate-to-severe Alzheimer's disease. Forest expects a refiling and submission of new study data by year's end. Of note is new data from a recent Phase III trial of memantine in combination with Pfizer Inc.'s Aricept (donepezil).

"The data provide a significant opportunity for the product-combo therapy with all three acetylcholinesterase inhibitors on the market at a minimum," says Morgan Stanley analyst Marc Goodman. He raised memantine forecasts by $65 million to $315 million in 2007.