Milan, Italy, April 7, 2014 – 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 Application for Authorization for safinamide has been submitted to Swissmedic.
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, who will be the Authorization holder.
About safinamide
Safinamide, an alpha-aminoamide, is 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 the development of novel therapies for patients with diseases of the Central Nervous System (CNS) and pain. The Company is headquartered in Bresso near Milan, Italy. Following the submission of the Marketing Authorization Application (MAA) for safinamide for the treatment of Parkinson’s disease to the European Medicines Agency (EMA) in December 2013, Newron is working to complete the global filing of the compound, together with its partners. Zambon Group 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. Newron’s additional projects are based on highly promising treatments for rare disease patients and are at various stages of clinical development, including sNN0031 for patients with Parkinson’s disease, non-responsive to oral drug treatments, sarizotan for patients with Rett syndrome, sNN0029 for patients with ALS and ralfinamide for patients with specific rare pain indications. Newron is concurrently developing NW-3509 as the potential first add-on therapy for the treatment of patients with positive symptoms 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 Investors and analysts
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 3727 1000
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
Stefan Weber - CEO
Phone: +39 02 6103 46 30
E-mail: ir@newron.com
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