Meiji Seika Pharma granted Eisai exclusive rights to commercialize the Parkinson’s disease drug, safinaminde, in Japan, South Korea, Taiwan, Brunei, Cambodia, Laos, Malaysia, and the Philippines. Meiji is developing the selective monoamine oxidase B (MAO-B) inhibitor in Japan and key Asian territories under a 2012 agreement with Italian firm Newron Pharmaceuticals, which originally discovered safinamide.
Under terms of the deal between Meiji and Eisai, Meiji will receive an undisclosed upfront payment, plus future development milestones and sales royalties. The firm will continue to conduct ongoing clinical Phase II/III trials in Japan, which are evaluating safinamide in combination with levodopa. Meiji will also be responsible for regulatory filing in Japan. Eisai will shoulder clinical development of safinamide and related regulatory activities for the Asian markets. Meiji will manufacture and supply the drug for both clinical programs.
Newron’s first partner for safinamide, Merck Serono, announced in 2011 that it would hand the then Phase III-stage drug back to the Italian firm, citing reasons including pipeline review and more limited market potential for safinamide than originally anticipated. Newron subsequently partnered with Zambon in May 2012 to develop safinamide globally, except in Meiji’s territories of Japan and specified Asian geographies. Zambon subsequently granted the rights to develop and commercialize Xadago in the U.S., to US WorldMeds. The FDA approved Xadago last month as add-on therapy to levodopa/carbidopa.
The drug was approved by the European Commission in February 2015 as add-on therapy to levodoa alone or in combination with other Parkinson’s disease drugs. Swiss approval followed in November 2015. Xadago has been launched in 11 European countries.