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Safinamide Phase III Study Results Presented at 2013 MDS Meeting
Date:6/18/2013

MILAN, June 19, 2013 /PRNewswire/ --


Safinamide significantly improves responder rates in fluctuating Parkinson's disease (PD) patients as add-on to levodopa

Safinamide is associated with clinically important improvement in motor symptoms in fluctuating PD patients as add-on to levodopa

 

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, presented results from SETTLE Phase III study with safinamide at the 17th International Congress of Parkinson's disease and Movement Disorders, taking place from June 16 to 20, 2013, at the Sydney Convention and Exhibition Centre, Sydney, Australia.

Results presented showed that in the SETTLE study safinamide significantly improved "super responder" rates in fluctuating PD patients as add-on to levodopa and other dopaminergic therapies. Safinamide was also associated with clinically important improvement in motor symptoms in fluctuating PD patients as add-on to levodopa and other dopaminergic therapies.

Ravi Anand, Newron's CMO, stated: "The results presented indicate a magnitude of benefit with safinamide which is of clinical relevance, i.e. improvements of more than one hour in the patient and caregiver-rated ON and OFF time plus 30 per cent or greater improvement in motor symptoms (UPDRS Part III, as rated by a neurologist) in a significantly (p=0.018) larger proportion of patients than standard of care. These results demonstrate that safinamide produces clinically important improvements even in the more severe patients treated with numerous drugs. Patients who improve by such magnitude in these domains can be referred to as "super responders" and have not been observed with other treatments to date. In addition, safinamide shows a very rapid onset of efficacy with significant improvements being observed in ON-time (p=0.0003) and OFF-time (p<.0001) from week two onwards. These results will be part of the regulatory submission planned to be filed in Europe and USA in QIV/2013."

"The responder rate analysis using multiple and combined criteria show compelling evidence that a substantial proportion of Parkinson's disease patients, even in advanced stage treated with safinamide obtain significant clinical benefits in all major motor symptoms thus significantly improving their quality of life", said Marco Sardina, Zambon's CSO.

SETTLE study was a six-month (24-week), randomized, double-blind, placebo-controlled international Phase III trial. It enrolled 549 patients with mid-to late-stage idiopathic Parkinson's disease (more than three years of disease duration) treated with optimized, stable doses of levodopa and standard of care (dopamine agonist, COMT inhibitor, anticholinergic and/or amantadine) for at least four weeks. Patients who were experiencing a minimum of one and a half hours of "OFF" time during the day were randomized equally to treatment with once a day safinamide (50-100mg) or placebo (standard of care including levodopa), as adjunctive treatment. Based on discussions with the regulatory authorities, the primary endpoint of the trial was the change in daily "ON" time, as assessed by the patient completed daily diary cards (18 hours/day).

Safinamide was very well tolerated. 484 patients completed the trial; the drop-out rate was similar in both treatment groups (approx. 12%). The most commonly reported adverse events were nausea, urinary tract infections, falls, back pain and dyskinesia. Transient dyskinesia occurred more frequently with safinamide, but was mainly mild, and was not associated with treatment discontinuation. Similarly, the incidence of treatment emergent abnormalities in laboratory results, ophthalmological examinations, vital signs and ECG was similar in all groups.

Analyses (On treatment, ANCOVA-LOCF) performed in the ITT population showed treatment with safinamide 50-100 mg/day significantly improved ON-Time without troublesome dyskinesia compared to placebo by 0.96 ± 0.21 hours (p<0.01) in the ITT. Significant benefits of safinamide 50-100 mg/day were also reported in OFF-time, Motor symptoms (UPDRS III), PDQ39, EQ-5D, clinical global impression of change and severity, and OFF-time post morning dose of levodopa.

The abstract presented at the MDS is available for download at: http://www.newron.com/ENG/Default.aspx?SEZ=5&PAG=122 and

http://http://www.zambonpharma.com

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. http://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: http://www.zambongroup.com

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. In some cases these statements and assumptions can be identified by the fact that they use words such as "will", "anticipate", "estimate", "expect", "project", "intend", "plan", "believe", "target", and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron's strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron's research programmes, development activities, commercialisation plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions.

Newron does not undertake any obligation to publicly up-date or revise forward looking statements except as may be required by applicable regulations of the SIX Swiss Exchange where the shares of Newron are listed.

This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.


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