MILAN--(BUSINESS WIRE)--Nov 30, 2018--Zambon S.p.A., an international pharmaceutical company strongly committed to the central nervous system (CNS) therapeutic area, and its partner Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced the recent approval of Xadago®/safinamide in Australia by the Therapeutic Goods Administration (TGA) of the Australian Government Department of Health for the treatment of adult patients with fluctuating idiopathic Parkinson’s disease (PD) as add-on therapy to a regimen that includes levodopa (L-Dopa).

Xadago has been registered on the Australian Register of Therapeutic Goods (ARTG), which is the formal requirement for supply and marketing of the medicine. Under a partnership agreement with Zambon, Seqirus, a global leader in influenza prevention and a leading provider of essential vaccines and pharmaceuticals in Australia and New Zealand, has undertaken the registration with the Australian authorities and will now work to supply Xadago.

Roberto Tascione, CEO of Zambon, said: “ The approval of safinamide in Australia is a great step forward for patients who need new treatment options for Parkinson’s disease. Our partner Seqirus is committed to launch this product and make this innovative therapy available to patients suffering from Parkinson’s disease in Australia.”

Xadago/safinamide is commercialized by Newron’s partner Zambon; it is approved in Switzerland as well as the European Union (currently available in 13 of its member states). US WorldMeds holds the commercialization rights in the USA, where the compound has been launched in July 2017. Meiji Seika has the rights to develop and commercialize safinamide in Japan and other key Asian territories; Meiji Seika Pharma has filed for marketing approval of safinamide with the Japanese Pharmaceutical and Medical Device Agency in October 2018. Further dossiers for marketing authorization are currently under review in Brazil, Canada, Colombia and Israel. Zambon is also currently leading discussions on additional distribution agreements in Europe and the Middle East.

About safinamide (Xadago®)

Safinamide is a new chemical entity with a unique mode of action including selective and reversible MAO-B-inhibition and blocking of voltage dependent sodium channels which leads to modulation of abnormal glutamate release. Clinical trials have established its efficacy in controlling motor symptoms and motor complications in the short term, maintaining this effect over 2 years. Results from 24-month, double-blind controlled studies suggest that safinamide shows statistically significant effects on motor fluctuations (ON/OFF time) without increasing the risk of developing troublesome dyskinesia. This effect may be related to its dual mechanism acting on both the dopaminergic and the glutamatergic pathways. Safinamide is a once-daily dose and has no diet restrictions due to its high MAO-B/MAO-A selectivity. Zambon has the rights to develop and commercialize Xadago® globally, excluding Japan and other key Asian territories where Meiji Seika has the rights to develop and commercialize safinamide. The rights to develop and commercialize Xadago® in the USA have been granted to US WorldMeds, by Zambon.

References:

Two-year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson's disease. Borgohain, Rupam; Szasz, Jozsef; Stanzione, Paolo; Meshram, Chandrashekhar; Bhatt, Mohit H et al. (2014)

Movement disorders : official journal of the Movement Disorder Society vol. 29 (10) p. 1273-80.

Anand R: Safinamide is associated with clinically important improvement in motor symptoms in fluctuating PD patients as add-on to levodopa (SETTLE). 17th International Congress of Parkinson’s Disease and Movement Disorders, Sydney, Australia, June 16-20, 2013.

About Parkinson’s disease

PD is the second most common chronic progressive neurodegenerative disorder in the elderly after Alzheimer’s disease, affecting 1-2% of individuals aged ≥ 65 years worldwide. The prevalence of the PD market is expected to grow in the next years due to the increase in the global population and advancements in healthcare that contribute to an aging population at increased risk for PD. The diagnosis of PD is mainly based on observational criteria of muscular rigidity, resting tremor, or postural instability in combination with bradykinesia. As the disease progresses, symptoms become more severe. Early-stage patients are more easily managed on L-dopa. L-dopa remains as the most effective treatment for PD, and over 75% of the patients with PD receive L-dopa. However, long term treatment with L-dopa leads to seriously debilitating motor fluctuations, i.e. phases of normal functioning (ON-time) and decreased functioning (OFF-time). Furthermore, as a result of the use of high doses of L-dopa with increasing severity of the disease, many patients experience involuntary movements known as L-dopa-Induced Dyskinesia (LID). As the disease progresses, more drugs are used as an add-on to what the patient already takes, and the focus is to treat symptoms while managing LID and the “off-time” effects of L-dopa. Most current therapies target the dopaminergic system that is implicated in the pathogenesis of PD, and most current treatments act by increasing dopaminergic transmission that leads to amelioration of motor symptoms.

References:

BMC Oertel. European Handbook of Neurological Management, Vol 1, Chapter 14 & 15, 2011.

NICE PD guideline, 2006.

About Zambon

Zambon is a multinational pharmaceutical and fine-chemical company that focuses on innovation and development with the aim to improve the quality of people’s health and patients’ lives. Based on a valuable heritage but strongly focused on the future, its goal is to improve people’s health through the development of innovative and quality medicines. Zambon products are commercialized in 86 countries. The company has 20 subsidiaries in three different Continents – Europe, America and Asia – and owns manufacturing units in Italy, Switzerland, France, China and Brazil. The company today has a strong focus on the treatment of rare diseases and specialties, such as Parkinson’s disease and Cystic Fibrosis, and it’s well-established in 3 therapeutic areas: respiratory, pain and women’s care. Zambon was established in 1906 in Italy and today counts around 2,700 employees all over the world. For details on Zambon please visit

About Newron Pharmaceuticals

Newron (SIX: NWRN) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The Company is headquartered in Bresso near Milan, Italy. Xadago®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland and the USA, and is commercialized by Newron’s Partner Zambon. US WorldMeds holds the commercialization rights in the USA. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. In addition to Xadago®/safinamide for Parkinson’s disease, Newron has a strong pipeline of promising treatments for rare disease patients at various stages of clinical development, including Sarizotan for patients with Rett syndrome and ralfinamide for patients with specific rare pain indications. Newron is also developing Evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia. For more information, please visit:

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 update 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 announcement is not an offer for sale of securities in the United States, Canada, Australia or Japan or any other jurisdiction where such an offer or solicitation would otherwise be unlawful. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended. Newron does not intend to register any of its securities in the United States or to conduct a public offering of its securities in the United States. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of this document shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.

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CONTACT: Zambon

Valentina Saffioti -Global Head of Pharma Communication

+39 0266524508 -valentina.saffioti@zambongroup.com

Newron

Stefan Weber – CEO

+39 02 6103 46 26 -pr@newron.com

UK/Europe: Julia Phillips / Natalie Garland-Collins, FTI Consulting –

+44 20 3727 1000 -SCnewron@fticonsulting.com

Switzerland:Martin Meier-Pfister, IRF Communications

+41 43 244 81 40 -martin.meier-pfister@irfcom.ch

Germany/Europe: Anne Hennecke, MC Services

+49 211 52925222 -anne.hennecke@mc-services.eu

USA- Paul Sagan, LaVoieHealthScience

+1 617 374 8800, Ext. 112 -psagan@lavoiehealthscience.com

KEYWORD: AUSTRALIA UNITED STATES EUROPE NORTH AMERICA AUSTRALIA/OCEANIA ITALY

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY PHARMACEUTICAL OTHER SCIENCE SCIENCE

SOURCE: Newron Pharmaceuticals S.p.A.

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PUB: 11/30/2018 07:00 AM/DISC: 11/30/2018 07:01 AM

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