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Press Release

Newron Provides End of Year Corporate Update

Newron
Posted on: 11 Dec 17

Significant progress in 2017 including US Xadago approval, STARS initiation, Evenamide results

 

Milan, Italy – December 11, 2017 – 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 provides an end of year market update.

 

Significant progress has been made in 2017 with the approval and launch of Xadago for the treatment of patients with Parkinson’s disease (PD) in the US in July, and its commercialization in twelve European countries. A study with Xadago to demonstrate the reduction of dyskinesia in PD patients with Levodopa Induced Dyskinesia (LID), scheduled to start in 2018, is in planning together with our partner Zambon.

 

The “Sarizotan Treatment of Apneas in Rett Syndrome” (STARS) study, a potentially pivotal study, now includes patients as young as six years, following approval by the US FDA and health authorities in Italy, Australia, the UK and India. Newron expects to announce the results of this study in 2018. As previously stated, Newron plans to commercialize Sarizotan for Rett syndrome directly in key markets.

 

Preclinical results indicating glutamate antagonism mechanism of Evenamide, together with clinical results indicating a benefit in patients not responding to atypical antipsychotics as well as plans to evaluate Evenamide in patients with schizophrenia in two studies, have been discussed with a number of European and the Canadian health authorities, with meetings with CHMP and FDA planned for early 2018. Newron intends to initiate one study each in patients with schizophrenia experiencing worsening of psychosis on atypical antipsychotics, and in treatment resistant patients not responding to clozapine. It is estimated that this latter condition affects approximately 20,000 patients in the US, thus allowing Newron and/or other mid-sized companies the opportunity to commercialize Evenamide directly.

 

Newron’s current cash position after completing a private placement in September 2017 is approximately €60m, enabling Newron to fund its planned clinical trials into 2020, well beyond the key inflection points, as well as current and future research and development and other general corporate activities.

 

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: www.newron.com

 

For more information, please contact

 

Media

Investors and Analysts

 

Newron
Stefan Weber – CEO
+39 02 6103 46 26
pr@newron.com

 

Newron
Stefan Weber – CEO
+39 02 6103 46 26
ir@newron.com

UK/Europe
Julia Phillips, FTI Consulting
+44 20 3727 1000
julia.phillips@FTIConsulting.com

UK/Europe
Julia Phillips, FTI Consulting
+44 20 3727 1000
julia.phillips@FTIConsulting.com

Switzerland
Martin Meier-Pfister, IRF Communications
+41 43 244 81 40
martin.meier-pfister@irfcom.ch  

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

Germany/Europe
Anne Hennecke, MC Services
+49 211 52925222
anne.hennecke@mc-services.eu

USA
Alison Chen, LaVoieHealthScience
+1 617 374 8800, Ext. 104
achen@lavoiehealthscience.com

USA
Beth Kurth, LaVoieHealthScience
+1 617 374 8800, Ext. 106
bkurth@lavoiehealthscience.com

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 11/12/2017

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