Eisai and Meiji Seika Pharma have entered into a license agreement for the development and commercialization of safinamide for the treatment of Parkinson’s disease in Japan and Asia. Safinamide is currently under clinical development by Meiji in Japan.
Eisai will obtain exclusive rights to safinamide to market in Japan and to develop and market in seven other Asian countries. Meiji will continue the clinical trials that it is currently conducting and submit a manufacturing and marketing authorization application for the drug in Japan. Meanwhile, Eisai will conduct clinical trials for seeking regulatory approval, and make the applications in Asia. Meiji will manufacture and supply the product of safinamide to Eisai for Japan and Asia. In addition, Meiji will receive an upfront payment from Eisai, as well as developmental milestone and sales royalty payments under the agreement.
Safinamide is a selective monoamine oxidase B (MAO-B) inhibitor, which reduces the degradation of excreted dopamine, helping to maintain the density of dopamine in the brain. Additionally, safinamide blocks sodium ion channels and inhibits glutamate release, and as such, has potential as a new Parkinson’s disease treatment, which possesses both dopaminergic and non-dopaminergic mechanisms. Global clinical trials of safinamide in combination with levodopa for the treatment of mid- to late-stage Parkinson’s disease showed extended “on” time, and an improvement in motor function.