MDX-8704, a fixed-dosed combination (FDC) of memantine HCl extended release capsules and donepezil HCl, is being developed as a once daily therapy for the treatment of moderate-to-severe dementia of the Alzheimer’s type in the United States.
The $25m milestone payment was paid to Adamas as a result of the Food and Drug Administration’s (FDA) acceptance of the New Drug Application for MDX-8704. Pursuant to the license agreement between Forest and Adamas, Forest paid Adamas a $65m upfront payment in November 2012 and $40m in the fourth quarter of 2013 for work related to the development of MDX-8704.
Subsequent to this most recent $25 m payment, there is up to a $30m milestone payable upon FDA approval. Also under the terms of the license agreement, Adamas will receive royalties on US net sales of Namenda XR and MDX-8704 beginning five years after their launches.
Leveraging Adamas’ know-how and intellectual property, the companies are collaborating on the development of MDX-8704, for which Forest has exclusive US commercialization rights. Forest is also responsible for all US regulatory-related activities. Adamas retains exclusive commercialization rights outside the US. MDX-8704 is covered by a Forest patent and multiple Adamas patents that extend up to 2029.