Newron and Zambon file for EU approval of Parkinson's drug safinamide

Italian drug developer Newron Pharmaceuticals (SIX: NWRN) and its partner, family-owned Italian drugmaker Zambon have filed Marketing Authorization Application (MAA) for safinamide with the European Medicines Agency.

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 based on completion of activities agreed on during meetings with a number of European national health authorities, the rapporteur and co-rapporteur for safinamide (Netherlands and the UK) as well as the Committee for Medicinal Products for Human Use (CHMP).

Under the terms of a licensing deal last year (The Pharma Letter April 9, 2012), Zambon will be the Marketing Authorization holder. The company has exclusive rights to develop and commercialize the drug worldwide, excluding certain Asian territories that have been granted to Meiji Seika Pharma.