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Xadago

Generic name: safinamide
Treatment for: Parkinson's Disease

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

Safinamide New Drug Application (NDA) Submitted to the U.S. Food and Drug Administration (FDA)

Milan, Italy, May 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 the New Drug Application (NDA) for safinamide was submitted today to the US Food and Drug Administration (FDA).

The submission covers the indications “safinamide as add-on therapy to a stable dose of a single dopamine agonist” in early Parkinson’s disease patients and “safinamide as add-on therapy to levodopa alone or in combination with other Parkinson’s disease treatments” in mid-to late stage Parkinson’s disease patients. The submission was based on completion of activities agreed upon during meetings with the FDA.

The submission was made by Newron, which is the NDA holder until completion of the sublicense process for the US rights to safinamide, by Zambon.

Stefan Weber, Newron’s CEO, commented: “We are both proud and excited to be submitting the Company’s first ever NDA, for safinamide. Parkinson's disease is a debilitating condition and this brings us one crucial step closer to providing an innovative treatment to improve the quality of life for these patients.”

Ravi Anand, Newron’s CMO, commented: “Following the usual review periods, we are optimistic that safinamide will receive approval within Europe by end of this year, and in the US within 12 months. After submission of the filings in the European Union, the US and Switzerland, we will now support filings in additional territories based on the US and EU documentation, as planned by our partners.”

Maurizio Castorina, Zambon Pharma CEO, stated: “Zambon is strongly commit- ted to preparing the launch of safinamide in territories core to its strategy, and to advancing and completing the licensing process for additional territories, includ- ing the US. We are convinced that safinamide will bring benefits to both patients and Health Authorities alike.”

Marco Sardina, Zambon Pharma CSO, added: “There is still a strong medical need for new, safer therapies to effectively treat motor symptoms and motor complications of Parkinson’s disease patients. Zambon and its sublicencees will take the actions required to fully exploit the innovative therapeutic potential of safinamide.”

About Parkinson’s disease

Parkinson’s disease is a degenerative disorder of the central nervous system that often impairs the patient’s motor skills and speech. Parkinson's disease belongs to a group of conditions called movement disorders. It is characterized by muscle rigidity, tremor, a slowing of physical movement (bradykinesia) and, in extreme cases, a loss of physical movement (akinesia). The primary symptoms are the results of decreased stimula- tion of the motor cortex by the basal ganglia, normally caused by the insufficient formation and action of dopamine, which is produced in the dopaminergic neurons of the brain. Secondary symptoms may include high-level cognitive dysfunction and subtle language problems. Parkinson’s disease is both chronic and progressive. It is estimated that more than 3 million people in the industrialized countries suffer from Parkin- son’s disease.

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) (December 2013) as well as to Swissmedic (March, 2014 by Zambon), Newron is working to complete the global filing of the compound, together with its partners. Zambon Group has the rights to commercialize safinamide global- ly, excluding Japan and other key Asian territories where Meiji Seika has the rights to develop and commer- cialize the compound. Newron’s additional projects are based on highly promising treatments for rare dis- ease patients and are at various stages of clinical development, including sNN0031 for patients with Parkin- son’s disease, non-responsive to oral drug treatments, sarizotan for patients with Rett syndrome, sNN0029 for patients with ALS and ralfinamide for patients with specific rare pain indications. Newron is concurrently developing NW-3509 as the potential first add-on therapy for the treatment of patients with positive symp- toms 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: May 2014

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