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Forest, Adamas announce licensing agreement for dementia therapy
NEW YORK—Forest Laboratories Inc. and Adamas Pharmaceuticals Inc. have announced the signing of a licensing agreement to develop and commercialize a fixed dose combination 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 disease type in the United States.
Per the terms of the agreement, the two companies will collaborate to develop the fixed-dose combination. Forest will be responsible for all development and commercialization activities, and will have exclusive U.S. commercialization rights. Adamas will receive a $65 million upfront payment as well as up to $95 million in future development and U.S. Food and Drug Administration (FDA) approval milestones. In addition, Adamas will also be eligible to receive royalties on U.S. net sales starting five years after the launch for fixed dose combination products and any additional memantine products for which its patents are listed in the FDA's Orange Book.
"We are pleased to partner with Forest, the market leader in Alzheimer's products, to bring our fixed dose combination of extended release memantine and donepezil—the first such combination therapy for Alzheimer 's disease—to the U.S. market," Gregory T. Went, CEO of Adamas, said in a press release. "This collaboration will accelerate this innovative product's development towards a 2014 U.S. NDA filing, and allow Adamas to focus our attention on the ex-U.S. market for the product and to continue the ongoing development of Nurelin, our late-stage product candidate for the treatment of CNS disorders, including Parkinson's disease."
Namenda XR is an FDA-approved, once-daily formulation of Namenda, Forest's successful Alzheimer's therapy, which the company sells in the United States under a 2000 license from Merz & Co. GmbH & Co. According to a development plan that both Adamas and the FDA have agreed to, the fixed dose combination is expected to launch in 2015 following FDA approval. The product will be covered by several Adamas patents that extend to 2029.
"We are pleased to enter into this partnership with Adamas, which will enable us to enhance our life cycle program for Namenda," Howard Solomon, chairman, president and CEO of Forest, said in a statement regarding the deal. "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 U.S., in light of our successful track record in the field of Alzheimer's disease with Namenda.
"Over 60 percent 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."