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Newron Pharmaceuticals (NWRN) Release: Safinamide Marketing Authorization Application (MAA) Submitted To The European Medicines Agency


12/5/2013 10:54:12 AM

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Milan, Italy, December 5, 2013 – Newron Pharmaceuticals S.p.A. (“Newron”), 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, announce that the Marketing Authorization Application (MAA) for safinamide was submitted today 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 program.”

About safinamide

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.

About Newron Pharmaceuticals

Newron (SIX: NWRN) is a biopharmaceutical company focused on novel therapies for diseases of the Central Nervous System (CNS) and pain. The Company is headquartered in Bresso near Milan, Italy. Based on the phase III results of safinamide for treatment of Parkinson’s disease, Newron is working to expedite the global filing of the compound, together with its partners. Zambon Group has the rights to commercialise safinamide globally, excluding Japan and other key Asian territories, and Meiji Seika has the rights to develop and commercialise safinamide in Japan and other key Asian territories. Newron’s additional projects are primarily addressed towards highly promising treatments for rare diseases and are at various stages of preclinical and clinical development, including sNN0031 for Parkinson’s disease, sarizotan for Rett’s syndrome, sNN0029 for ALS, ralfinamide for specific pain indications, and NW-3509 as potential first add-on therapy for the treatment of schizophrenia. www.newron.com

About Zambon

Zambon is a leading Italian pharmaceutical and fine-chemical multinational company, that has earned a strong reputation over the years for high quality products and services. Zambon is well-established in 3 therapeutic areas: respiratory, pain and woman care, and is very strongly committed to its entry into the CNS space. Zambon SpA produces high quality products thanks to the management of the whole production chain which involves Zach (Zambon chemical), a privileged partner for API, custom synthesis and generic products. The Group is strongly working on the treatment of the chronic respiratory diseases as BPCO and on the CNS therapeutic area with safinamide for the Parkinson treatment. Zambon is headquartered in Milan and was established in 1906 in Vicenza. Zambon is present in 15 countries with more than 2,600 employees with manufacturing units in Italy, Switzerland, France, China and Brazil. For details on Zambon please see: www.zambongroup.com

For more information, contact:

Media

Italy

Stefan Weber - CEO

Phone: +39 02 6103 46 26

E-mail: pr@newron.com

UK/Global media

Julia Phillips

FTI Consulting

Phone: +44 (0) 20 7269 7187

Zambon Company

Luca Primavera

Phone: +39 02 66524491

Mobile: +39 335 7247417

Email: luca.primavera@zambongroup.com

Switzerland

Martin Meier-Pfister

IRF Communications

Phone: +41 43 244 81 40

Investors and analysts

Stefan Weber - CEO

Phone: +39 02 6103 46 30

E-mail: ir@newron.com

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