Eisai has entered into a license agreement with Meiji Seika Pharma, a Tokyo-headquartered pharmaceutical company, for the commercialization of safinamide for treating Parkinson’s disease in Japan and Asia. Safinamide is currently under clinical development by Meiji in Japan.

Under the agreement, Eisai will obtain exclusive rights to safinamide to market in Japan and to develop and market in seven countries in Asia: South Korea, Taiwan, Brunei, Cambodia, Laos, Malaysia, and the Philippines. Meiji will continue clinical trials that it is currently conducting and will submit a manufacturing and marketing authorization application for the drug in Japan. Eisai will conduct clinical trials for seeking regulatory approval and make the applications in Asia. Meiji will manufacture and supply safinamide to Eisai for Japan and Asia. 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 inhibitor that reduces the degradation of excreted dopamine, according to Eisai. The drug was discovered and developed by Newron Pharmaceuticals, headquartered in Milan, Italy. In 2011, Newron entered into a licensing agreement with Meiji, granting Meiji exclusive rights to develop, manufacture, and commercialize the drug in Japan and Asia.

Safinamide is marketed under the brand name Xadago in 11 countries in Europe and was approved by the US Food and Drug Administration in March 2017. In Japan, Meiji is currently conducting Phase II/III trials for safinamide in combination with levodopa, a drug widely used to treat Parkinson’s disease.

Source: Eisai