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Xadago

Generic name: safinamide
Treatment for: Parkinson's Disease

Update: Xadago (safinamide) Now FDA Approved - March 21, 2017

Refusal to File Letter Received from US FDA for Safinamide, Based on Organization and Navigation Problems

Milan, Italy, July 29, 2014 – Newron Pharmaceuticals S.p.A. (“Newron”), a re- search and development company focused on novel CNS and pain therapies, and its partner Zambon S.p.A., an international pharmaceutical company strongly committed to the CNS therapeutic area with a long experience in respiratory dis- ease therapies, woman care and primary care, announce that Newron has re- ceived today a Refusal to File (RTF) letter from the FDA for safinamide.

The submission of safinamide to the US FDA, for use as add-on therapy for pa- tients with Parkinson’s disease, was made in May 2014. Upon preliminary review, the FDA identified some organization and navigation problems, relating to the hyperlinking of tables, folders and the organization of the table of contents in the submission, as well as the conformation of the Package Insert to FDA guidelines. The Refusal to File letter does not relate to the acceptability of the clinical data, and no judgment is made on the efficacy or safety of safinamide. Newron be- lieves that the additional information needed to support this filing is available and is working closely with the FDA to resubmit the application as quickly as possible.

Ravi Anand, MD, Newron’s CMO commented “The RTF letter is a disappoint- ment, however, the issues identified are largely technical. Newron has today filed a request with the FDA for a Type A meeting to promptly identify and correct these technical issues. Based on the RTF letter, Newron believes these issues will be addressed expeditiously.”

About Safinamide

Safinamide, an alpha-aminoamide, is currently being developed by Newron as an add-on therapy to dopa- mine agonists or to levodopa in patients with early or mid- to late-stage Parkinson’s disease (PD). It is be- lieved to have both dopaminergic and non dopaminergic activities, including selective and reversible inhibi- tion of monoamine oxidase B (MAO-B), activity-dependent sodium channel antagonism and inhibition of glutamate release in vitro.

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 indi- cations. Newron is also developing NW-3509 as the potential first add-on therapy for the treatment of pa- tients with positive symptoms of schizophrenia. www.newron.com

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 SpA 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 BPCO and on the CNS therapeutic area with safinamide for the Parkinson treatment. Zambon is headquartered in Milan and was established in 1906 in Vicenza. Zambon is present in 15 countries with more than 2,600 employees with manufacturing units in Italy, Switzerland, France, China and Brazil. For details on Zambon please see: www.zambongroup.com

Source: Newron Pharmaceuticals S.p.A.

Posted: July 2014

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