Zambon S.p.A., an international pharmaceutical company strongly committed to the CNS therapeutic area, and its partner Newron Pharmaceuticals S.p.A. (Newron), a research and development company focused on novel CNS and pain therapies, announced the launch of Xadago (safinamide) in Germany for the treatment of mid- to late-stage Parkinson’s disease (PD). Germany is the first country in which Xadago, which has been approved as 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, is launched.

Prof. Heinz Reichmann, Chair Dept. Neurology University of Dresden stated: “When a Parkinson's disease patient is no longer optimally controlled with levodopa, Xadago may become the first choice as add-on to levodopa, because it has shown a balanced control of motor symptoms and motor complications. These benefits have been proved at six months and maintained over two years. The reason why is its unique mechanism of action, dopaminergic and non dopaminergic targets. Xadago uniquely combines the modulation of the dopamine and glutamate systems, which in add-on therapy may maximise motor symptom control in Parkinson’s disease without worsening motor complications. In due course, most Parkinson’s disease patients worldwide could benefit from the advantages of Xadago."

Maurizio Castorina, CEO of Zambon SpA said: “The launch of Xadago in Germany represents a significant milestone in Zambon’s pharmaceutical business and in particular our increased commitment to R&D innovation. The launch of Xadago is a major step forward in the treatment of Parkinson's disease, and Zambon is fully committed to invest further for the benefit of all Parkinson’s disease patients.”

Stefan Weber, CEO of Newron commented: “We are pleased that patients with Parkinson’s disease in Germany now have access to a much needed innovative add-on treatment option. Xadago has shown meaningful improvements in ‘ON and OFF time’, without any increase in symptoms such as dyskinesia. As Newron and partner Zambon continue to pursue additional marketing authorizations, we look forward to seeing access of Xadago expanded to patients in other regions in Europe and the US.”

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 unequivocally established its efficacy in controlling motor symptoms and motor complications in the short term, maintaining this effect also in the long term (over 2 years). Results from long-term (24 months) double-blind controlled studies suggest that Safinamide shows significant effects on motor fluctuations (ON/OFF time) without increasing the risk of developing troublesome dyskinesia. This positive effect may be related to its dual mechanism acting on both the dopaminergic and the glutamatergic pathways. Safinamide is well tolerated with a favorable side-effect profile and is easy to use: once-daily dose, no need of LD adjustment, no major drug–drug interactions, no diet restrictions due to its high MAO-B/MAO-A selectivity.

The New Drug Application (NDA) for Xadago to the US FDA was accepted for filing by the US FDA, PDUFA date is Dec. 29, 2015. In March 2014, Zambon submitted an MAA to Swissmedic. 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.