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Newron Pharmaceuticals

Xadago launched; eyes now on pipeline assets

Outlook | Pharmaceutical & healthcare | 13 Oct 2017

Following an encouraging year to date we have upgraded our forecasts for Xadago (Parkinson’s disease [PD] therapy), and key CNS pipeline assets sarizotan (Rett syndrome) and Evenamide (schizophrenia). Sublicensee partner US WorldMeds launched Xadago into the US market in July 2017; Xadago is now available in the majority of key markets worldwide through partners. Importantly Newron’s CNS R&D pipeline is progressing; clinical data and commercial opportunity details presented on Evenamide and sarizotan at the R&D day in May have prompted upgrades to our peak sales forecasts and valuation. Our updated valuation is CHF754m.

Newron Pharmaceuticals

Xadago receives FDA approval in PD

Flash note | Pharmaceutical & healthcare | 22 Mar 2017

Newron and its partners Zambon and US WorldMeds have announced that the FDA has approved Xadago (safinamide) for Parkinson's disease (PD) patients as an add-on therapy to levodopa/carbidopa. While we had expected approval (following the revised PDUFA date of 21 March), the certainty of approval removes a major overhang on the stock, and as such we expect a positive share price reaction. We expect launch in the US market in H217 by sub licensee US WorldMeds. Our valuation of Newron remains unchanged at CHF530m.

Newron Pharmaceuticals

Marching into 2017

Update | Pharmaceutical & healthcare | 13 Mar 2017

We anticipate that the sales and pipeline progression made by Newron in 2016 will be cemented further in 2017/18. A critical catalyst remains the US Xadago (Parkinson's disease (PD) therapy) approval which is imminent (revised PDUFA date is 21 March); this will materially impact the share price performance. We anticipate US launch in H217 by sub licensee, US WorldMeds. Data from pipeline assets sarizotan (Rett's syndrome, RS) and evenamide (schizophrenia) in the upcoming 18 months will highlight Newron's diverse, innovative CNS-based R&D portfolio. We value the company at CHF530m.

Newron Pharmaceuticals

Back on track

QuickView | Pharmaceutical & healthcare | 09 Nov 2016

Xadago (safinamide) for Parkinson's disease (PD) is back on track in theUS as the FDA has informed the company and its partners, Zambon andUS WorldMeds, that no further clinical studies will be required followingthe 29 March complete response letter. Newron resubmitted Xadago's NDAin September; US PDUFA date is set for 21 March 2017. In Europe theXadago roll-out is ongoing, with commercial partner Zambon havinglaunched the product in multiple European countries. We value Newron atCHF494m or CHF34.7/share.

Newron Pharmaceuticals

Back on track

Outlook | Pharmaceutical & healthcare | 02 Sep 2016

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 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.

Newron Pharmaceuticals

Xadago US approval slips out further

Flash note | Pharmaceutical & healthcare | 31 Mar 2016

Newron has received a complete response letter from the FDA for its Parkinson's disease drug Xadago (safinamide). Specifically, the FDA has requested clinical data on the potential effect of Xadago relating to abuse liability and dependence/withdrawal effects. No further efficacy or safety data for Xadago in patients with Parkinson's disease has been requested. In next steps Newron will meet with Controlled Substance Staff (CSS) of the FDA to discuss exact requirements to address the issue. We anticipate that Newron will need to provide data relating to abuse liability and dependence in healthy subjects, and thus additional trials may be required. As such, we place our financial forecasts and valuation under review until we receive clarity on next steps and the potential impact on regulatory approval and market launch in the US.

Newron Pharmaceuticals

US partner on board ahead of PDUFA date

Flash note | Pharmaceutical & healthcare | 18 Mar 2016

Commercial partner, Zambon, has announced a sublicence agreement with US WorldMeds for the US commercialisation of Parkinson's disease (PD) therapy Xadago (safinamide). Under the agreement's terms Zambon will give Newron a share of undisclosed, upfront milestone and royalty payments made by US WorldMeds, in addition to a milestone payment on FDA approval (we estimate €9m, not included in our forecasts). Importantly Xadago's US PDUFA date is looming (29 March 2016) and a positive decision will clearly bode well for Newron's share price. Our valuation of Newron remains unchanged at CHF504m or CHF35.5/share.

Newron Pharmaceuticals

Xadago European roll-out continues

Update | Pharmaceutical & healthcare | 15 Mar 2016

At its FY15 results Newron reported €0.5m (vs our €0.8m estimate) in royalties from commercial partner, Zambon after seven months of Xadago (Parkinson's disease therapy) sales in Germany. So far in 2016 Zambon has also launched Xadago in Italy, Switzerland and Spain. The Xadago US PDUFA date is 29 March 2016, and a Xadago sublicensing deal in the US and a potential partnership for NW-3509 are on the cards. We have lowered our valuation slightly to CHF504m (vs CHF522m) primarily to reflect an increase in R&D expenses to support the mid-stage pipeline.

Newron Pharmaceuticals

Plans for sarizotan to enter pivotal development

Update | Pharmaceutical & healthcare | 18 Dec 2015

Newron Pharmaceuticals is an Italian CNS-focused biotechnology company. Safinamide/Xadago for Parkinson's disease has been approved in mid-late PD in Europe and launched in Germany; the US PDUFA date is 29 March 2016. Safinamide is partnered with Zambon and Meiji Seika.

Newron Pharmaceuticals

First Xadago sales; US decision by end Q116

QuickView | Pharmaceutical & healthcare | 09 Nov 2015

Xadago for the treatment of Parkinson's disease is now generating initial sales in Europe following first launch in Germany, leading to royalty income to Newron from partner Zambon. The US regulatory review was recently extended by three months to end March 2016. Beyond Xadago, Newron has prioritised development of orphan drug sarizotan for Rett syndrome (a rare genetic condition) with a pivotal trial planned to start in Q415. Partnering candidate NW-3509 for schizophrenia is also advancing.

Newron Pharmaceuticals

Xadago launches in Germany

Update | Pharmaceutical & healthcare | 20 May 2015

Xadago has been launched in Germany as expected by commercial partner Zambon, which should lead to Newron's first recurring royalty income. Xadago has been priced at a premium to Azilect in Germany, which if replicated in other countries and regions, could suggest upside potential to our current forecasts and valuation. We continue to expect a Xadago US approval decision by YE15. Our valuation and forecasts have been updated to reflect the CHF24.3m fund-raise, with our valuation CHF526m.

Newron Pharmaceuticals

Progression, partnering and prioritisation

Outlook | Pharmaceutical & healthcare | 26 Mar 2015

With Xadago (safinamide) now formally approved in Europe this should trigger first royalty income from commercial partner Zambon upon launch, which is initially targeted in Germany. Safinamide in the US is now back on track with an approval decision expected by YE15. A safinamide sub-licensing deal in the US, in addition to partnering NW-3509 are both on the cards. Our valuation is increased to CHF496m (€466m) with a higher safinamide royalty in addition to a risk-adjusted contribution in dyskinesia.