Safinamide marketing application submitted to Swissmedic

Italian drug developer Newron Pharmaceuticals (SIX: NWRN) and its partner, family-owned Italian drugmaker Zambon say that the Application for Authorization for safinamide has been submitted to Swissmedic, Switzerland’s medicines regulator.

The submission covers the indications “safinamide as add-on therapy to a stable dose of a single dopamine agonist” in early Parkinson’s disease patients and “safinamide as add-on therapy to levodopa alone or in combination with other Parkinson’s disease treatments” in mid-to late stage Parkinson’s disease patients. The submission was made by Zambon, which will be the Authorization holder.

Following the submission of the Marketing Authorization Application for safinamide for the treatment of Parkinson’s disease to the European Medicines Agency last year (The Pharma Letter December 9,2013), Newron is working to complete the global filing of the compound, together with its partners. Zambon has the rights to commercialize safinamide globally, excluding Japan and other key Asian territories where Meiji Seika has the rights to develop and commercialize the compound (TPL April 9, 2012).