Forest Laboratories and Adamas Pharmaceuticals have signed a licensing deal for the development and commercialisation of a fixed dosed combination (FDC) of Namenda XR and donepezil HCl to treat Alzheimer’s disease in the US.
According to the agreement, the companies will partner to develop the FDC but Forest will hold exclusive US commercialisation rights, and is responsible for all development and commercialisation activities.
The FDC product, which will be patent protected until 2029, is expected to launch in 2015 following FDA approval.
Forest chairman, CEO and president Howard Solomon said studies have shown that Namenda and donepezil used together improve cognition, function and behaviour 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," Solomon said.
Under the agreement, Forest will make a $65m upfront payment to Adamas which is even eligible to receive $95m in future development and FDA approval milestones along with royalties on net sales in the US.
Adamas CEO Gregory Went said; "This collaboration will accelerate this innovative product’s development towards a 2014 US NDA filing, and allow Adamas to focus our attention on the ex-US 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."