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Nov 14, 2012

Fixed-Dosed Drug Combination for Alzheimer's

  • Forest Laboratories and Adamas Pharmaceuticals entered into an agreement for the development and commercialization of a fixed-dosed combination (FDC) of Namenda XR® (memantine HCl extended release) and donepezil HCl as a once-daily therapy for the treatment of moderate to severe dementia of the Alzheimer’s type in the United States. Under the agreement, Forest and Adamas will collaborate on the development of the FDC, and Forest will have exclusive U.S. commercialization rights. Forest is responsible for all development and commercialization activities.

    Forest will pay Adamas $65 million upfront and up to $95 million in future development and FDA approval milestones. Adamas will receive royalties on U.S. net sales beginning five years after launch for FDC products and any additional memantine products for which Adamas’ patents are listed in the FDA’s Orange Book.

    Namenda XR is Forest’s FDA approved, once-daily formulation of its Alzheimer’s therapy Namenda®. Based on a development plan agreed to by Adamas and the FDA, the FDC is expected to launch in 2015 following FDA approval. The product will be covered by multiple Adamas patents that extend to 2029. Forest sells Namenda in the U.S. under a 2000 license from Merz & Co.

    Adamas was founded in 2004 to develop new therapeutics for CNS disorders based on improvements to a class of drugs called aminoadamantanes, including amantadine and memantine. Adamas is currently advancing two programs through Phase III clinical studies: Arimenda™ (ADS-8704; memantine ER and donepezil) for Alzheimer’s disease, and Nurelin™ (ADS-5102; amantadine ER), initially for Levodopa-induced dyskinesia (LID).

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