Newron Pharmaceuticals S.p.A., a research and development company focused on novel CNS and pain therapies, and its partner Zambon S.p.A., a pharmaceutical company strongly committed to the respiratory, primary care and CNS therapeutic areas, have submitted the Marketing Authorization Application (MAA) for safinamide to the European Medicines Agency (EMA).

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 upon 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). Zambon will be the Marketing Authorization holder.

Stefan Weber, Newron’s CEO, commented: “Parkinson's disease is a debilitating condition and we are excited to be one step closer to providing a new treatment to improve the quality of life for patients. We are proud of this great achievement. This is the first MAA submitted by Newron and is the result of many months of dedicated hard work. We are optimistic that safinamide will receive timely approval from the EMA in 2014.”

Ravi Anand, Newron’s CMO, commented: “The submission was based on a comprehensive evaluation of the safety of safinamide in more than 2000 Parkinson’s disease patients, many of whom were treated for over four years; and efficacy, derived from five placebo controlled studies including assessments performed under double-blind conditions for two years. Newron’s focus will now be directed towards completing the submission of the New Drug Application (NDA) to the US Food and Drug Administration, who did not request any additional pre-clinical or clinical studies at the pre-NDA meeting. Newron expects to complete the remaining activities required to comply with requirements for NDA submission in the first quarter of 2014.”

Maurizio Castorina, Zambon Pharma CEO, stated: “Zambon is strongly committed in preparing the launch of safinamide and will be ready as soon as regulatory authorities will give the green light. I’m personally convinced that safinamide will bring benefits to both patients and Health Authorities, as to Zambon.”

Marco Sardina, Zambon Pharma CSO, added: “There is still a strong medical need for new safer therapies to treat effectively motor symptoms and motor complications of PD patients. Zambon is preparing to fully exploit the new therapeutic potential of safinamide through a top class clinical phase IIIb/IV programme.”

Safinamide, an alpha-aminoamide, is currently being developed by Newron as an add-on therapy to dopamine agonists or to levodopa in patients with early or mid- to late-stage Parkinson’s disease (PD). It is believed to have both dopaminergic and non dopaminergic activities, including selective and reversible inhibition of monoamine oxidase B (MAO-B), activity-dependent sodium channel antagonism and inhibition of glutamate release in vitro.

Newron is a biopharmaceutical company focused on novel therapies for diseases of the Central Nervous System (CNS) and pain.