PRESS RELEASE:
All AGM/EGM Motions Accepted by Vast Majorities of Represented Shareholders
MILAN–(BUSINESS WIRE)–March 22, 2016–
Newron Pharmaceuticals S.p.A. (“Newron”), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain, announced that shareholders approved all motions on the agenda of its shareholders meeting held in Bresso (MI), Italy, today.
Stefan Weber, CEO of Newron commented: “It’s with the greatest satisfaction that Xadago® is being made available to patients suffering from Parkinson’s disease in the European Union and in Switzerland by our partner, Zambon. The US commercialization partner for the product, US WorldMeds, was announced last week. We are now advancing with confidence towards the upcoming decision by the US Food and Drug Administration (FDA) on our New Drug Application (NDA).”
Stefan Weber continued: “We are making great steps towards the initiation of the first potentially pivotal study performed in patients with Rett Syndrome, a debilitating rare disease in girls and women. We expect to begin this study in the second quarter. If successful, Sarizotan could become the first therapy to be commercialized by Newron.”
“Finally, we expect the first efficacy data in patients with positive symptoms of schizophrenia by end of this year with NW-3509, the first voltage-gated sodium channel blocker being developed in that indication, as add-on therapy. We are proud of the support shown by our shareholders on our path forward.”
At the Shareholders’ Meeting held today, 22 March 2016 in Bresso (MI), Italy, shareholders approved all motions on the agenda, including the grant to the Board of Directors of the powers to increase the share capital, allowing the pursuit of the Company’s strategy, and the approval of the Company’s financial statements as of 31 December 2015. Shareholders also appointed the statutory auditors under Italian law and the audit company, both for a three-year term.
About Newron Pharmaceuticals
Newron (SIX: NWRN), Bresso / Italy, is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain. Xadago® (Safinamide) has received marketing authorization for the treatment of Parkinson’s disease in the European Union and Switzerland and is commercialized by Newron’s Partner Zambon. The US New Drug Application (NDA) has been accepted for review by the FDA, PDUFA date March 29, 2016. US WorldMeds holds the commercialization rights in the US. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. Newron’s additional projects are based on highly promising treatments for rare disease patients and are at various stages of clinical development. They include Sarizotan for patients with Rett Syndrome, for which Newron received Orphan Drug Designation in both the US and the EU, ralfinamide for patients with specific rare pain indications, and NW-3509 as potentially the first add-on therapy for the treatment of patients with positive symptoms of schizophrenia. www.newron.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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For Investors and Analysts
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Anne Hennecke, +49 211 52925222
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bkurth@lavoiehealthscience.com
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