Newron submits safinamide NDA

Newron Pharmaceuticals S.p.A. (SIX:NWRN) submitted an NDA to FDA for safinamide to treat Parkinson's disease (PD). The application covers the use of safinamide as add-on therapy to a stable dose of a single dopamine agonist for patients with early PD; and as add-on therapy to levodopa alone or in combination with other treatments in patients with mid- to late-stage PD. Zambon Co. S.p.A. (Bresso, Italy) has exclusive rights from Newron to develop and commercialize safinamide worldwide, excluding Asian territories, where Meiji Seika Pharma Co. Ltd. (Tokyo, Japan) has rights. According to Newron, Zambon is sublicensing U.S. rights to safinamide because it lacks a commercial presence in the country. Newron is the holder of the NDA while Zambon is in the process of sublicensing U.S. rights.

Safinamide is also under review in the EU, with a decision expected by year end. Last month, Zambon submitted an application to Swissmedic for the product, an alpha-aminoamide derivative that acts as a reversible monoamine oxidase B (MAO-B) and dopamine reuptake inhibitor while reducing glutamatergic activity. ...