Xadago (safinamide) for Parkinson’s disease (PD) is back on track in the US as the FDA has informed the company and its partners, Zambon and US WorldMeds, that no further clinical studies will be required following the 29 March complete response letter. Newron Pharmaceuticals SpA (SIX:NWRN) will re-submit Xadago’s NDA by end November and now anticipates US approval mid-2017. In Europe the Xadago roll-out is ongoing, with commercial partner Zambon having launched the product in multiple European countries. We value Newron at CHF494m or CHF34.7/share.
Xadago US back on track for NDA resubmission
The FDA no longer requires any extra clinical studies on Xadago’s potential abuse liability or dependence/withdrawal effects; thus Newron will expedite the NDA resubmission. This removes uncertainty surrounding Xadago’s US future filing. We have re-instated our forecasts and now anticipate US launch in H217. Importantly, partner Zambon continues its roll-out of the drug across Europe; it is now available in 11 European countries and further launches are expected this year.
Evenamide schizophrenia Phase II data due Q416
The US Phase II proof-of-concept trial is ongoing, assessing the novel mechanism of action drug, evenamide (NW-3509) as an add-on to antipsychotics in patients with positive symptoms of schizophrenia. Phase II data are expected in Q416. NW-3509 is a partnering candidate, given the potential size of the indication and its differentiating mode of action. Partnering activities could provide upside.
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