N8W hat am 11.01.2016 - 10:47 folgendes geschrieben:
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Safinamide (Xadago®) has been approved and launched in Europe
Safinamide is a once a day, oral, adjunctive therapy for the treatment of PD. The drug has demonstrated benefit as an add-on treatment to dopamine agonists used in early PD and also when used in combination with levodopa (without increasing dyskinesias) in late-stage PD. On 26 February 2015, safinamide (branded Xadago®) gained marketing approval in Europe as an add-on to L-dopa alone or in combination with dopamine agonists, entacapone, amantadine, and/or anticholinergics, for the treatment of mid-late stage PD patients experiencing motor fluctuations despite being stabilised on standard of care. In May 2015, Newron’s partner Zambon launched Xadago® in Germany and this was followed in November by approval of the drug in Switzerland. In the US, the FDA is currently reviewing the NDA for safinamide and has set a PDUFA date of 29 March 2016. Partner, Meiji Seika pharma commenced a Phase II/III trial of safinamide in Japan in October 2015.
Newron Pharmaceuticals - BUY
Newron is entitled to a significant share of Zambon sublicensing income
Safinamide is partnered with Zambon, an Italian chemical and pharmaceutical company that has global (ex-Japan and Asia) rights to the product and with Meiji Seika Pharma (Japan and other key Asian markets). While Zambon has marketing infrastructure in Europe, the company will need to find a partner to market safinamide in the US. Our forecasts assume an estimated $150 million in upfront and launch milestones paid to Zambon on US sublicensing – we have not assumed any additional sales milestones in Europe or the US, or any milestone income for Japan – a conservative approach in our view. We estimate that Newron is entitled to approximately one third of any milestone income that Zambon receives from sublicensing safinamide as well as a 50% share of royalties. We note that Zambon is a significant shareholder of Newron (owning 9.2%).
We estimate year 6 sales post launch of safinamide exceeding $450 million
We estimate there are approximately 800,000 Parkinson’s patients on dopamine agonists in the US and approximately 400,000 taking some form of levodopa. Our forecasts assume only late-stage use in Europe, but both early- and late-stage use in the US and Japan. We believe our assumptions are conservative as they assume a modest penetration of the market and conservative pricing assumptions. We believe our sales estimates could be significantly enhanced should a successful Phase III trial of safinamide be completed demonstrating a reduction in dyskinesias and adding weight to the differentiated dual mechanism of action of the drug.
Sarizotan and NW-3509 could generate significant value
Beyond safinamide Newron has a number of drugs in its pipeline that we consider have significant potential, however have generated limited data to date. Sarizotan was inlicensed from Merck KGaA and came with a substantial clinical data package. Targeting the Orphan indication of Rett syndrome, sarizotan could reach the market relatively quickly (potentially 2018) and could be the first product Newron directly markets. NW-3509 is targeting the blockbuster indication of schizophrenia and we believe Newron could execute a significant licensing deal for the drug on positive Phase II results. As these additional pipeline programmes progress they have the potential to generate significant value for the Company.
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