Zambon announces approval and ARTG listing of Safinamide in Australia for treatment of patients with Parkinson’s disease

FURTHER REGULATORY SUBMISSIONS ONGOING WITH AUTHORITIES WORLDWIDE

Milan, Italy – November 30, 2018 – 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 Australia and 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.”