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Newron Pharmaceuticals (NWRN) Submits US IND for NW-3509, a Potential Add-On Treatment for Patients with Schizophrenia


7/13/2011 8:58:58 AM

Milan, Italy – July 13, 2011 - Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel CNS and pain therapies announced today that it has submitted to the US FDA an investigational new drug (IND) application for NW-3509, the first selective, voltage gated sodium channel (VGSC) modulator, being specifically developed for schizophrenia therapy. The application is seeking FDA approval to conduct a first human dosing trial in non-patient volunteers. The IND submission follows prior meetings with the FDA and MHRA (UK) and incorporates their suggestions and recommendations.

NW-3509 has demonstrated activity in numerous models that mimic psychotic disorders, especially schizophrenia, both as monotherapy and as add-on treatment to currently available anti-psychotics. It significantly reduces abnormalities in pre-pulse inhibition (PPI), a measure of information processing and cognition, that has shown to be abnormal in patients with schizophrenia. The addition of NW-3509 to the treatment regimen of patients who are not benefitting adequately from their current medication, has the potential to result in clinical benefits and to allow the use of lower dose anti-psychotic treatments, thus significantly reducing dose-dependent side effects.

NW-3509 is an innovative compound from a new chemical class, stemming from Newron’s ion channel programme. Its mechanism of action involves selective modulation of voltage-gated sodium channels (VGSC) that have been implicated in the pathogenesis of psychiatric and neurological disorders.

Ravi Anand, M.D., Newron’s Chief Medical Officer, said, “NW-3509 provides a unique approach to the treatment of patients with psychosis who are not responding to the currently available treatments, that largely block dopaminergic and serotonergic receptors. NW-3509, instead, targets voltage gated sodium channels, providing the opportunity to normalize aberrant neuronal firing and glutamatergic hyperactivity, that have been implicated in the patho-physiology of schizophrenia. Therefore, the addition of NW-3509 to the current treatments may extend the benefits in symptoms of psychosis and significantly reduce the side effects experienced by patients.”

About Newron Pharmaceuticals

Newron Pharmaceuticals S.p.A. (www.newron.com) is a biopharmaceutical company focused on novel therapies for diseases of the Central Nervous System and pain. Phase III trials of safinamide are currently ongoing for the treatment of Parkinson’s disease (PD). As per the agreement signed with Newron in 2006, Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has exclusive worldwide rights to develop, manufacture and commercialize the compound in PD, Alzheimer’s disease, and other therapeutic applications. Newron is currently evaluating the further clinical development of ralfinamide for pain and psychiatric diseases. Newron’s additional projects are at various stages of preclinical and clinical development, including HF0220 for neuroprotection, NW-3509 for the treatment of schizophrenia, as well as pruvanserin and sarizotan for treatment of CNS diseases. Newron is headquartered in Bresso, near Milan, Italy. The company is listed at SIX Swiss Exchange, trading symbol NWRN.

For more information, contact:

Media

Italy

Luca Benatti - CEO

Phone: +39 02 6103 4 626

E-mail: pr@newron.com

UK/Global media

Julia Phillips

Financial Dynamics

Phone: +44 (0) 20 7269 7187

Switzerland

Martin Meier-Pfister

IRF Communications

Phone: +41 43 244 81 40

Investors and analysts

Stefan Weber - CFO

Phone: +39 02 6103 46 30

E-mail: ir@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.

Mo Noonan

Senior Manager

Financial Dynamics

Holborn Gate, 26 Southampton Buildings

London, WC2A 1PB

D +44 (0)20 7269 7116

M +44 (0)7876 444 977

www.fd.com


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