Japanese firms file for safinamide approval in Japan

Japanese pharma company Eisai (TYO: 4523) saw its shares fall 4.06% to 10,155 yen despite announcing, with partner Meiji Seika, that an application seeking manufacturing and marketing approval in Japan was submitted as of today by Meiji for the Parkinson’s disease treatment ME2125 (safinamide mesylate).

This application is primarily based on a double-blind, placebo-controlled Phase II/III study to evaluate the efficacy and safety of safinamide as add-on therapy, as well as an open label Phase III study to evaluate the safety and efficacy of long-term administration of safinamide in Japanese patients with Parkinson's disease with wearing-off phenomenon who are currently receiving levodopa.

Under the license agreement signed between Eisai and Meiji in March 2017, Eisai has the exclusive rights to market safinamide in Japan, as well as to develop and market safinamide in Asia. Meiji conducted clinical trials, and then submitted a manufacturing and marketing authorization application for the drug in Japan. Eisai will submit applications for manufacturing and marketing approval for the drug in Asia.