Newron Pharmaceuticals and Partner Zambon Support Parkinson's Disease Awareness Day 2016

MILAN--()--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 nervous system (CNS) and pain, and its partner Zambon S.p.A., an international pharmaceutical company strongly committed to the central nervous system (CNS) therapeutic area, today acknowledge and support World Parkinson’s Disease Awareness Day. In addition, the companies re-state their commitment to the ongoing approvals and launches of Xadago® (safinamide) for the treatment of Parkinson’s disease in the EU, the US and, through Newron’s partner Meiji Seika, in Japan and certain Asian countries. In Switzerland, Germany, Spain, Italy and Belgium, Xadago® (safinamide) is available as add-on therapy to levodopa (L-dopa) alone or in combination with other PD therapies for mid-to late-stage fluctuating patients.

Maurizio Castorina, CEO of Zambon S.p.A., said: “Our efforts in bringing to patients with PD an innovative treatment like Xadago® (safinamide) are being rewarded by the positive feedback that we have received from clinicians and patients in the countries where we have launched to date. We look forward making Xadago® available to more patients in need of a new therapeutic option.”

“With an estimated 6.3 million* people with Parkinson’s disease worldwide, it is truly rewarding to have developed the first New Chemical Entity (NCE) in 10 years to receive a Marketing Authorization from the EU Commission for the treatment of Parkinson’s disease. We look forward to patients around the world with Parkinson’s disease having access to this important therapeutic option,” said Stefan Weber, CEO of Newron Pharmaceuticals.

Lizzie Graham, Executive Director of the European Parkinson’s Disease Association (EPDA), commented: “The EPDA welcomes the work being done by Newron and others in bringing new treatments to improve the lives of people with Parkinson’s disease and their families.”

*European Parkinson’s Disease Association (EPDA) www.epda.eu.com

About Xadago® (safinamide)
Safinamide is a new chemical entity with a unique mode of action including selective and reversible MAO-B-inhibition, use-dependent Na channels blockade and Ca channels’ modulation which lead to modulation of abnormal glutamate release. Clinical trials have unequivocally established its efficacy in controlling motor symptoms and motor complications in the short term, maintaining this effect also in the long term (over 2 years). Results from long-term (24 months) double-blind controlled studies suggest that safinamide shows significant effects on motor fluctuations (ON/OFF time) without increasing the risk of developing troublesome dyskinesia. This positive effect may be related to its dual mechanism acting on both the dopaminergic and the glutamatergic pathways. Safinamide is well tolerated with a favourable side-effect profile and is easy to use: once-daily dose, no need of LD adjustment, no major drug–drug interactions, no diet restrictions due to its higher MAO-B/MAO-A selectivity.

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 Parkinson’s disease. 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. There is a growing belief that targeting non-dopaminergic systems may lead to improvements in PD symptoms such as dyskinesia that are not improved by current dopaminergic therapies.

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 S.p.A. 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 asthma and BPCO and on the CNS therapeutic area with Xadago® (Safinamide) for the Parkinson treatment. Zambon is headquartered in Milan and was established in 1906 in Vicenza. Zambon is present in 19 countries with subsidiaries and almost 2,700 employees with manufacturing units in Italy, Switzerland, France, China and Brazil. Zambon products are commercialized in 84 countries.

For details on Zambon please see: www.zambongroup.com

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. 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. For additional information, please visit http://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.

Contacts

Media
Zambon
Luca Primavera, +39 02 66524491
Mobile: +39 335 7247417
CCO
luca.primavera@zambongroup.com
or
Italy
Milva Naguib, +39 02 66524095
Mobile: +39 3459215675
milva.naguib@zambongroup.com
or
Newron
Stefan Weber, +39 02 6103 46 30
CEO
ir@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
Alison Chen, +1-617-374-8800, Ext. 104
achen@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

Release Summary

Newron and Zambon support World Parkinson's Disease Awareness Day. The companies re-state their commitment to the ongoing approvals and launches of Xadago® (safinamide) to treat Parkinson's disease

Contacts

Media
Zambon
Luca Primavera, +39 02 66524491
Mobile: +39 335 7247417
CCO
luca.primavera@zambongroup.com
or
Italy
Milva Naguib, +39 02 66524095
Mobile: +39 3459215675
milva.naguib@zambongroup.com
or
Newron
Stefan Weber, +39 02 6103 46 30
CEO
ir@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
Alison Chen, +1-617-374-8800, Ext. 104
achen@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