NEW YORK—Forest Laboratories Inc. and Adamas PharmaceuticalsInc. have announced the signing of a licensing agreement to develop andcommercialize a fixed dose combination of Namenda XR (memantine HCl extendedrelease) and donepezil HCl as a once-daily therapy for the treatment ofmoderate to severe dementia of the Alzheimer's disease type in the United States.
Per the terms of the agreement, the two companies willcollaborate to develop the fixed-dose combination. Forest will be responsiblefor all development and commercialization activities, and will have exclusiveU.S. commercialization rights. Adamas will receive a $65 million upfrontpayment as well as up to $95 million in future development and U.S. Food andDrug Administration (FDA) approval milestones. In addition, Adamas will also beeligible to receive royalties on U.S. net sales starting five years after thelaunch for fixed dose combination products and any additional memantineproducts for which its patents are listed in the FDA's Orange Book.
"We are pleased to partner with Forest, the market leader inAlzheimer's products, to bring our fixed dose combination of extended releasememantine and donepezil—the first such combination therapy for Alzheimer'sdisease—to the U.S. market," Gregory T. Went, CEO of Adamas, said in a pressrelease. "This collaboration will accelerate this innovative product'sdevelopment towards a 2014 U.S. NDA filing, and allow Adamas to focus ourattention on the ex-U.S. market for the product and to continue the ongoingdevelopment of Nurelin, our late-stage product candidate for the treatment ofCNS disorders, including Parkinson's disease."
Namenda XR is an FDA-approved, once-daily formulation ofNamenda, Forest's successful Alzheimer's therapy, which the company sells inthe 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 FDAapproval. The product will be covered by several Adamas patents that extend to2029.
"We are pleased to enter into this partnership with Adamas,which will enable us to enhance our life cycle program for Namenda," HowardSolomon, chairman, president and CEO of Forest, said in a statement regardingthe deal. "Adamas has made impressive progress with its combination extendedrelease memantine and donepezil program. Forest is the ideal company tocomplete the development of this product and commercialize it in the U.S., inlight of our successful track record in the field of Alzheimer's disease withNamenda.
"Over 60 percent of Namenda patients already take Namendatogether with an acetylcholinesterase inhibitor like donepezil, which creates asubstantial market opportunity for this fixed dose combination product. Namendaand donepezil work in different ways and studies support that when usedtogether, they improve cognition, function and behavior in some patients withmoderate to severe Alzheimer's disease. This new fixed combination, whichreduces the pill requirement from three tablets to one and the dosing frequencyfrom two times per day to once per day, can benefit physicians, caregivers andpatients."