Memantine ER/donepezil regulatory update

FDA accepted for review an NDA from Forest for a once-daily, fixed-dose combination of memantine extended release (ER) and donepezil to treat moderate to severe dementia of the Alzheimer's type. The acceptance triggered a $25 million milestone payment from Forest to Adamas under a 2012 deal to develop and commercialize the product. Forest is responsible for regulatory activities and has exclusive U.S. commercialization rights to the product. Adamas retains exclusive rights outside of the U.S. (see BioCentury, Nov. 19, 2012 & Jan. 20, 2014). ...