Zambon Announces Approval And Artg Listing Of Safinamide In Australia For Treatment Of Patients With Parkinson’s Disease

Zambon S.p.A., an international pharmaceutical company strongly committed to the central nervous system (CNS) therapeutic area, and its partner 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 announced the recent approval of Xadago®/safinamide in Australia by the Therapeutic Goods Administration (TGA) of the Australian Government Department of Health for the treatment of adult patients with fluctuating idiopathic Parkinson’s disease (PD) as add-on therapy to a regimen that includes levodopa (L-Dopa).

Xadago has been registered on the Australian Register of Therapeutic Goods (ARTG), which is the formal requirement for supply and marketing of the medicine. Under a partnership agreement with Zambon, Seqirus, a global leader in influenza prevention and a leading provider of essential vaccines and pharmaceuticals in Australiaand New Zealand, has undertaken the registration with the Australian authorities and will now work to supply Xadago.

Roberto Tascione, CEO of Zambon, said: "The approval of safinamide in Australia is a great step forward for patients who need new treatment options for Parkinson’s disease. Our partner Seqirus is committed to launch this product and make this innovative therapy available to patients suffering from Parkinson’s disease in Australia."

Xadago/safinamide is commercialized by Newron’s partner Zambon; it is approved in Switzerland as well as the European Union (currently available in 13 of its member states). US WorldMeds holds the commercialization rights in the USA, where the compound has been launched in July 2017. Meiji Seika has the rights to develop and commercialize safinamide in Japan and other key Asian territories; Meiji Seika Pharma has filed for marketing approval of safinamide with the Japanese Pharmaceutical and Medical Device Agency in October 2018. Further dossiers for marketing authorization are currently under review in Brazil, Canada, Colombia and Israel. Zambon is also currently leading discussions on additional distribution agreements in Europe and the Middle East.

About safinamide (Xadago®)

Safinamide is a new chemical entity with a unique mode of action including selective and reversible MAO-B-inhibition and blocking of voltage dependent sodium channels which leads to modulation of abnormal glutamate release. Clinical trials have established its efficacy in controlling motor symptoms and motor complications in the short term, maintaining this effect over 2 years. Results from 24-month double-blind controlled studies suggest that safinamide shows statistically significant effects on motor fluctuations (ON/OFF time) without increasing the risk of developing troublesome dyskinesia. This effect may be related to its dual mechanism acting on both the dopaminergic and the glutamatergic pathways. Safinamide is a once-daily dose and has no diet restrictions due to its high MAO-B/MAO-A selectivity. Zambon has the rights to develop and commercialize Xadago® globally, excluding Japan and other key Asian territories where Meiji Seika has the rights to develop and commercialize safinamide. The rights to develop and commercialize Xadago® in the USA have been granted to US WorldMeds, by Zambon.