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Newron Pharmaceuticals (NWRN) Establishes U.S. Operations

7/8/2014 9:03:09 AM

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Milan, Italy – July 8, 2014 – Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel CNS and pain therapies, today announces the start of its operations in the United States. Newron Pharmaceuticals US, Inc. is located in Morristown, New Jersey, USA.

Newron recently submitted a New Drug Application for safinamide to the US Food and Drug Administration (FDA) for the use of safinamide as an add-on therapy at any stage of Parkinson’s disease. The Company is developing a portfolio of compounds in advanced clinical stages for orphan diseases of the Central Nervous System (CNS) as well as an innovative add-on therapy for positive symptoms in schizophrenia. Newron Pharmaceuticals US, Inc. will be responsible for interactions with the FDA and the conduct of clinical investigations of its compounds in the US.

Newron has recruited two senior industry executives who will be operating from the US office:

Stephen M. Graham, PhD, Executive Director Clinical Development, formerly Senior Director Clinical Development at Forest Research Institute, with over 20 years of experience in CNS clinical development including previous employment at Novartis and Boots.

William Leong, PhD, Senior Director Chemistry/Manufacturing/Controls (CMC), formerly Senior Director and Head of Process Chemistry at Celgene, also with over 20 years of experience at Celgene and Schering-Plough.

Stefan Weber, Newron’s CEO, commented: “Newron’s US operations in Morristown will play a key role in broadening our in-house resources in clinical development of CNS therapies, and in expanding our interactions with the FDA. Furthermore, the subsidiary will serve as the site for the future commercial operations of Newron for our clinical-stage portfolio of orphan compounds.”

About Newron Pharmaceuticals

Newron (SIX: NWRN) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the Central Nervous System (CNS) and pain. The Company is headquartered in Bresso near Milan, Italy. Following the submission of the Marketing Authorization Application (MAA) for safinamide for the treatment of Parkinson’s disease to the European Medicines Agency (EMA) in December 2013, to Swissmedic in March, 2014 as well as the New Drug Application NDA to the US FDA, Newron is working towards global approval of the compound, together with its partners. Zambon Group has the rights to commercialize safinamide globally, excluding Japan and other key Asian territories where Meiji Seika has the rights to develop and commercialize the compound. Newron’s additional projects are based on highly promising treatments for rare disease patients and are at various stages of clinical development, including sarizotan for patients with Rett syndrome, sNN0031 for patients with Parkinson’s disease, non-responsive to oral drug treatments, sNN0029 for patients with ALS and ralfinamide for patients with specific rare pain indications. Newron is also developing NW-3509 as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.

Stefan Weber - CEO
Phone: +39 02 6103 46 26

UK/Global media
Julia Phillips
FTI Consulting
Phone: +44 (0)20 3727 1000

Martin Meier-Pfister IRF Communications
Phone: +41 43 244 81 40

Investors and analysts
Stefan Weber - CEO
Phone: +39 02 6103 46 30

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