Italian CNS-focused drug developer Newron Pharmaceuticals’ (SIX: NWRN) key value driver is safinamide (branded Xadago), a once daily oral add-on therapy for all stages of Parkinson's disease with a unique dual mechanism of action, according to a new report on the company from ValuationLAB.
Xadago was first launched in the European Union in the second quarter of 2015.
On March 29, the drug unexpectedly received a US Food and Drug Administration Complete Response Letter (CRL), pushing back US approval by an estimated 12-18 months. Xadago was licensed to Meiji Seika (Japan & Asian markets) and Zambon (worldwide excluding Meiji Seika territories) in 2012. Substantial revenues are expected from sub-licensing, milestone and royalty payments from Xadago sales.
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