Board approves agenda for AGM on 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, announces its financial results for the year-ended December 31, 2015, reiterates material events and presents the outlook for 2016.

Key facts and events

Stefan Weber, CEO of Newron, said: "It is very rewarding to see Xadago® now available to patients suffering from Parkinson's disease. Xadago® has been approved and launched in several territories across Europe and is continuing to progress towards approval in both the U.S. and Japan. We are delighted to have made such major achievements in 2015."

Ravi Anand, Newron's CMO, added: "While Xadago® remained the main focus of 2015, sarizotan has made significant progress, too. In summer, both the European Commission and the U.S. FDA granted Orphan Drug Designation for sarizotan for the treatment of patients with Rett syndrome. We have carried out advanced and extensive discussions with regulatory authorities in Europe, the U.S. and Canada, and we are planning a pivotal, 24-week, double-blind, placebo-controlled efficacy study to start in Q2 2016. Previous studies indicate that sarizotan has the potential to reduce apneas and hyperventilation episodes significantly, therefore having the potential to improve the quality of life of patients with Rett syndrome and their carers. If approved, sarizotan is likely to be the first product approved for this devastating disease and the first product that Newron commercializes on its own."

Xadago® (safinamide) launched in Germany Early in the year, the European Commission approved the use of Xadago® for patients with mid-to-late-stage Parkinson's disease. Xadago® was approved as add-on therapy to levodopa alone or in combination with other Parkinson's disease treatments, making it the first new chemical entity in 10 years to receive approval for this indication. Most importantly, the label clearly lists the unique features of the product. In May, Newron's partner Zambon launched Xadago® in Germany and, following November's Swissmedic approval of Xadago® for use in Parkinson's disease patients in Switzerland, Zambon and Newron announced in early 2016 that Xadago® has been launched in Switzerland, Spain and Italy. The reception in Germany has been positive.

Further to this, in September the U.S. FDA New Drug Application late-cycle review meeting for Xadago® was completed with a PDUFA date of March 29, 2016. In October, the Japanese partner, Meiji Seika Pharma initiated Phase II/III confirmatory and Phase III long-term trials of safinamide as add-on therapy to levodopa for patients with Parkinson's disease in Japan who are experiencing the "wearing-off" phenomenon of their standard therapies. Xadago® has thus been approved and launched in several territories across Europe and is continuing to progress towards approval in both the U.S. and Japan.

Progress with sarizotan This new chemical entity is being developed for the treatment of Rett syndrome, a rare neurodevelopmental disorder. Mid-year, the Committee for Orphan Medicinal Products (COMP) adopted a positive opinion, recommending sarizotan as an orphan medicinal product to the European Commission for the treatment of patients with Rett syndrome. This was followed by both the European Commission and the U.S. FDA granting Orphan Drug Designation to sarizotan for the indication. Newron believes sarizotan has the ability to reduce apneas and hyperventilation episodes significantly, therefore having the potential to improve the quality of life of patients with Rett syndrome and, by reducing secondary cardio-respiratory complications, to extend the lives of girls and women with Rett syndrome. Following advanced discussions with regulatory authorities in Europe, the U.S. and Canada a pivotal, 24-week, double-blind, placebo-controlled efficacy study for sarizotan is currently being planned.

Secured financing of pipeline projects Newron's shareholders have been supportive and approved capital increases of up to 1.3 million additional shares to raise funds for developing the Company's pipeline assets. In April, institutional investors from Europe and the U.S. demonstrated their confidence in Newron by subscribing to 843,072 newly issued shares raising gross proceeds of EUR 23.4 million. Further to this, in November, Newron completed a private placement of 209,364 shares with a leading U.S. biotechnology and healthcare specialist fund, raising gross proceeds of EUR 4.9 million. These funds will be used to accelerate the development of the innovative product pipeline, namely the lead clinical programs, sarizotan in Rett syndrome and NW-3509, a novel add-on therapy for schizophrenia.

Financial Highlights

Group's liquidity, including available for sale financial assets and cash and cash equivalents, was EUR 41 million at year-end.

Newron's full annual report 2015 is available on http://www.newron.com/financial-report

Outlook Xadago® is now commercially available in Germany, Spain, Italy and Switzerland. The FDA has given a PDUFA date for Xadago® of March 29, 2016. The key pipeline projects sarizotan and NW-3509 are progressing well. The pivotal efficacy study with sarizotan is expected to start in Q2 2016 and results from the Phase II study of NW-3509 are anticipated in Q4 2016. On the basis of higher expected royalties on net sales of Xadago® in various European territories over the full-year period 2016 plus additional milestone payments and potential income from further licensing of Safinamide due from Zambon, 2016 revenue is expected to notably increase over 2015. R&D expenses will be higher compared to 2015, due to clinical development cost for the efficacy studies for sarizotan and NW-3509. The Group's liquidity will take Newron well into 2017, beyond expected key value inflexion points.

AGM/EGM 2016 Agenda Newron's Board of Directors has approved the below agenda for the March 22, 2016, 10:30 am CET, ordinary and extraordinary Shareholders' meeting, which will take place at the Company's registered office in Bresso (Mi), Italy. The formal invitation to shareholders will be issued and disclosed in the statutory papers on March 1. The full invitation and supporting material will be made available on the Company's website on the same date.

Dial-in to media / analyst conference on 1 March 2016, 9:15 - 10:15 am CET The Newron management team will present the full year results and provide an update and guidance for the development of Newron's R&D pipeline.

The slide deck used in the presentation is available at http://www.newron.com/downloads

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. Marketing authorization in the EU for Xadago® (safinamide) for the treatment of Parkinson's disease was granted by the EU Commission in February 2015, followed by Swissmedic's marketing authorization for Switzerland in November 2015. The drug has been launched by Newron's partner Zambon in the first key EU countries Germany, Spain and Italy, as well as in Switzerland. The New Drug Application (NDA) has been accepted for review by the FDA, PDUFA date March 29, 2016. Zambon has the rights to develop and 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. 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.

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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Media: Newron Stefan Weber, +39 02 6103 46 26 CEO pr@newron.com or UK/Europe FTI Consulting Julia Phillips, +44 (0)20 3727 1000 or Switzerland IRF Communications Martin Meier-Pfister, +41 43 244 81 40 or Germany MC Services AG Anne Hennecke, +49 211 52925222 anne.hennecke@mc-services.eu or U.S. LaVoieHealthScience David Connolly, +1-617-374-8800, Ext. 108 dconnolly@lavoiehealthscience.com or Investors and Analysts Newron Stefan Weber, +39 02 6103 46 30 CEO ir@newron.com or Germany MC Services AG Anne Hennecke, +49 211 52925222 anne.hennecke@mc-services.eu or U.S. LaVoieHealthScience Beth Kurth, +1-617-374-8800, Ext. 109 bkurth@lavoiehealthscience.com