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Zambon launches Xadago (safinamide) in Denmark and Sweden for patients with mid-to late stage 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., a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain, has announced the launch of Xadago® (safinamide) in Denmark and Sweden for the treatment of mid- to late stage Parkinson’s disease (PD).

Safinamide is a new chemical entity with a unique mechanism of action (MoA), dopaminergic and non-dopaminergic, providing a balanced control of motor symptoms and motor complications. It is now available in Denmark and Sweden as an add-on therapy to a stable dose of levodopa (L-dopa) alone or in combination with other PD therapies for mid-to late-stage fluctuating patients.

Associate Prof. M.D. Helle Thagensen from the Neurological Department, Roskilde University Hospital (Denmark), commented: “Safinamide is a safe and effective first adjunct therapy in levodopa-treated patients, improving both major symptoms of PD and providing benefits to mild and non-mild fluctuating patients who are receiving other concomitant dopaminergic therapies.”

Maurizio Castorina, CEO of Zambon S.p.A. said: “We are pleased that Xadago® is now available in Denmark and Sweden. This is another significant milestone for PD patients across the world now able to benefit from this novel therapy.”

With the addition of Denmark and Sweden, Xadago® is now available in seven countries including Germany, Switzerland, Spain, Italy and Belgium.

About Xadago® (safinamide)

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 territories where Meiji Seika has the rights to develop and commercialize the compound. The rights to develop and commercialize Xadago® in the USA have been granted to US WorldMeds, by Zambon.