Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical company, and Adamas Pharmaceuticals, Inc. announced today that they have 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 US commercialization rights. Forest is responsible for all development and commercialization activities. Namenda XR® is Forest’s FDA approved, once daily formulation of its successful 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. GmbH & Co.
Pursuant to the agreement, Forest will pay Adamas $65 million upfront and up to $95 million in future development and FDA approval milestones. Adamas will receive royalties on US net sales beginning 5 years after launch for FDC products and any additional memantine products for which Adamas’ patents are listed in the FDA’s Orange Book.
“We are pleased to enter into this partnership with Adamas, which will enable us to enhance our life cycle program for Namenda,” said Howard Solomon, Chairman, Chief Executive Officer and President of Forest. “Adamas has made impressive progress with its combination extended release memantine and donepezil program. Forest is the ideal company to complete the development of this product and commercialize it in the US, in light of our successful track record in the field of Alzheimer’s disease with Namenda. Over 60% of Namenda patients already take Namenda together with an acetylcholinesterase inhibitor like donepezil, which creates a substantial market opportunity for this fixed dose combination product. Namenda and donepezil work in different ways and studies support that when used together they improve cognition, function, and behavior in some patients with moderate to severe Alzheimer’s disease. This new fixed combination, which reduces the pill requirement from three tablets to one and the dosing frequency from two times per day to once per day, can benefit physicians, caregivers, and patients.”