Newron provides update on submission plans for safinamide Milan, Italy, November 14, 2012 - Newron Pharmaceuticals S.p.A. ("Newron"), a research and development company focused on Central Nervous System (CNS) and pain therapies, reports today that it has completed its initial series of meetings with European health authorities relating to the results of the preclinical, CMC, and clinical studies to support registration of safinamide as add-on therapy for the treatment of both early (non-fluctuating) and advanced (fluctuating) patients with idiopathic Parkinson's disease (PD). Safinamide is being developed by Newron and its partners Zambon Pharma S.p.A. and Meiji Seika Pharma Co. Ltd. The health authorities agreed with the adequacy of the safinamide program for preclinical toxicology, CMC, DMPK, and the size of the clinical safety data base that will be part of the submission. In addition, they provided feedback on the results of the studies demonstrating statistically significant efficacy of safinamide as add-on therapy in patients taking a stable dose of a single dopamine agonist in early PD patients, as measured by the UPDRS Part III (primary efficacy measure), and on motor fluctuations (measured by ON time; primary efficacy measure) in patients with advanced PD on levodopa and other PD treatments. Based on this feedback, Newron will proceed to meet with additional European health authorities, EMA and FDA to discuss its plans for global regulatory submission currently expected in second half of 2013. The efficacy and safety of safinamide as add-on to a stable dose of a single dopamine agonist was evaluated in patients with early PD in three placebo-controlled studies (009*, 015*, MOTION), while its therapeutic benefits as add-on to levodopa and other PD treatments in patients with advanced PD were studied in two placebo-controlled studies (016*, SETTLE). The presentation of the results of the recently completed MOTION and SETTLE studies has been scheduled for the 2013 AAN Annual Meeting, San Diego, USA, March 16-23, 2013. * previously reported About safinamide Safinamide is 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 Parkinson's disease Parkinson's disease is a degenerative disorder of the central nervous system that often impairs the patient's motor skills and speech. Parkinson's disease belongs to a group of conditions called movement disorders. It is characterized by muscle rigidity, tremor, a slowing of physical movement (bradykinesia) and, in extreme cases, a loss of physical movement (akinesia). The primary symptoms are the results of decreased stimulation of the motor cortex by the basal ganglia, normally caused by the insufficient formation and action of dopamine, which is produced in the dopaminergic neurons of the brain. Secondary symptoms may include high-level cognitive dysfunction and subtle language problems. Parkinson's disease is both chronic and progressive. It is estimated that more than 3 million people in the industrialized countries suffer from Parkinson's disease. 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. Phase III trials of safinamide for the treatment of Parkinson's disease (PD) have recently been completed. Based on the phase III results of safinamide, 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 rare diseases and are at various stages of preclinical and clinical development, including sarizotan for Rett's syndrome, 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 an Italian pharmaceutical and fine-chemical multinational company, earning a strong reputation over the years for high-quality products and services. Zambon was established in 1906 in Vicenza, where are based the Italian fine chemical and pharma plants. The other manufacturing units are in Switzerland, France, China and Brazil. Zambon is present in 15 countries with more than 2,500 employees. Zambon Company S.p.A. is the industrial holding of the group, with Zach (Zambon Chemicals) which is a preferred partner for API, Custom synthesis and generics products for big pharma companies; with Zambon S.p.A., the pharma business, which mainly operates in respiratory, pain and women healthcare; with Z-Cube, the corporate research venture, scouting new technologies and drug delivery system opportunities. Thanks to privileged relations with the scientific international community, Zambon is creating "Open Zone", a research and innovation Scientific Campus in Bresso (Milan). For details on Zambon see http://www.zamboncompany.com. For more information, contact: Media Investors and analysts Italy Stefan Weber - CEO Stefan Weber - CEO Phone: +39 02 6103 46 26 Phone: +39 02 6103 46 30 E-mail: email@example.com E-mail: firstname.lastname@example.org UK/Global media Julia Phillips FTI Consulting Phone: +44 (0) 20 7269 7187 Switzerland Martin Meier-Pfister IRF Communications Phone: +41 43 244 81 40 Important Notices This document contains forward-looking statements, including (without limitation) about (1) Newron's ability to develop and expand its business, successfully complete development of its current product candidates and current and future collaborations for the development and commercialisation of its product candidates and reduce costs (including staff costs), (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron's anticipated future revenues, capital expenditures and financial resources, and (4) assumptions underlying any such statements. 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Newron provides update on submission plans for safinamide
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