Newron Pharma Supports Rett Syndrome Awareness Month This October

Published: Oct 06, 2017

MILAN & MORRISTOWN, N.J.--(BUSINESS WIRE)--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, is pleased to support Rett Syndrome Awareness Month. October is dedicated to raising awareness for Rett syndrome through research initiatives, family empowerment and other advocacy events.

Stefan Weber, CEO of Newron, commented, “There are an estimated 36,000 girls living with Rett syndrome in the U.S. and the EU, with no approved treatments available. It is heartening to see the dedicated work advocacy groups such as rettsyndrome.org have done to improve the lives of these girls. Newron is proud to support Rett syndrome awareness month and we look forward to further contributing to the Rett syndrome community.”

As Newron continues to advance its efforts for the Rett community, the Company is sponsoring the largest and most comprehensive qualitative study to examine the burden of Rett syndrome on individuals and their caregivers. A poster entitled “Burden of Disease in Rett Syndrome: A Qualitative Analysis” was presented at the ISPOR 22nd Annual International Meeting in May (International Society for Pharmacoeconomics and Outcomes Research) in the U.S. This poster presented the results of a targeted literature search and preliminary findings from a qualitative interview study aimed at describing the burden of Rett syndrome on individuals and their families.

Earlier this year the FDA approved the amendment of Newron’s ongoing Sarizotan Treatment of Apneas in Rett Syndrome (STARS) study to include Rett syndrome patients as young as six years of age. The potential benefits of sarizotan will now also be evaluated in these younger patients prior to the significant worsening that occurs as these patients age. STARS is a randomized, double blind, placebo-controlled study, designed to evaluate the efficacy, safety and tolerability of sarizotan in patients with Rett syndrome suffering from respiratory symptoms. Among the core symptoms of Rett, breathing disturbances may affect the whole body; they can have a marked effect on biochemistry, influence emotions, circulation and digestive function as well as musculoskeletal structures in the respiratory process.

About Rett Syndrome

Rett syndrome is a severe neurodevelopmental disorder primarily affecting females, with an estimated prevalence ranging from one in 10,000 females. There are no approved treatments available. Rett syndrome is characterized by a loss of acquired fine and gross motor skills and the development of neurological, cognitive and autonomic dysfunction, which leads to loss of ability to conduct daily life activities, walk or communicate. Rett syndrome also is associated with a reduced life expectancy. Approximately 25 percent of the deaths in patients with Rett syndrome are possibly related to multiple cardio-respiratory dysrhythmias that result from brain stem immaturity and autonomic failure. More than 95 percent of these patients have a random mutation in the MeCP2 gene. Episodes of apnea, hyperventilation and disordered breathing are found in approximately 70 percent of patients with Rett syndrome at some stage of their life. For more information on Rett Syndrome, visit http://www.rettsyndrome.org.

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® 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 http://www.newron.com/en.

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.

Media
Newron
Stefan Weber, +39 02 6103 46 26
CEO
pr@newron.com
or
UK/Europe
FTI Consulting
Julia Phillips, +44 20 3727 1000
julia.phillips@FTIConsulting.com
or
Switzerland
IRF Communications
Martin Meier-Pfister, +41 43 244 81 40
martin.meier-pfister@irfcom.ch
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Germany/Europe
MC Services
Anne Hennecke, +49 211 52925222
anne.hennecke@mc-services.eu
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USA
LaVoieHealthScience
Alison Chen, +1 617-374-8800, Ext. 104
achen@lavoiehealthscience.com
or
Investors and Analysts
Newron
Stefan Weber, +39 02 6103 46 26
CEO
ir@newron.com
or
UK/Europe
FTI Consulting
Julia Phillips, +44 20 3727 1000
julia.phillips@FTIConsulting.com
or
Switzerland
IRF Communications
Martin Meier-Pfister, +41 43 244 81 40
martin.meier-pfister@irfcom.ch
or
Germany/Europe
MC Services
Anne Hennecke, +49 211 52925222
anne.hennecke@mc-services.eu
or
USA
LaVoieHealthScience
Beth Kurth, +1 617-374-8800, Ext. 106
bkurth@lavoiehealthscience.com

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