Newron Pharmaceuticals - Long-term generic challenge to Xadago

The FDA has notified Newron that an application for a generic safinamide (Xadago) has been filed. Xadago has new chemical entity (NCE) exclusivity until 27 March 2022. Xadago is then protected to December 2028 by three patents that have potential extensions to 2031. If Newron files to enforce its patents before mid-June 2021, as we expect, the FDA will not authorise a generic for up to 30 months (to September 2024) while the legal situation is clarified. However, if a generic is launched in the next few years, it might reduce our expectations of Xadago’s US sales potential. We retain our indicative value of CHF121m until the Xadago legal situation is clarified and the evenamide study 008A completes in late 2021.