Newron finally secures US approval for Parkinson's drug
- After a lengthy road to market, Newron Pharmaceuticals has secured approval of its Parkinson's disease drug Xadago (safinamide) from the Food and Drug Administration as an add-on therapy to levodopa/carbidopa.
- Newron's initial new drug application for Xadago to the FDA, submitted in May 2014, had been rejected due to organizational problems with the documents. The Italian biopharma subsequently resubmitted the drug later that year.
- Xadago is designed to reduce the duration of "off time", or time with decreased motor functioning, for Parkinson's patients already on optimized standard therapy.
Although Newron won approval, it won't be the company in charge of selling the drug in pretty much any developed jurisdiction.
Specialty pharma US WorldMeds holds commercialization rights to the drug in the U.S., which it secured through an Italian company called Zambon.
Back in 2012, Zambon had invested €20 million in Newron in exchange for an option to license Xadago in all territories except Japan and some other Asian countries. Zambon then turned around and sub-licensed U.S. rights to US WorldMeds in exchange for a milestone and royalty payment stream.
And in Japan and key Asian territories, the Japanese company Meiji Seika holds development and commercialization rights.
Xadago has been approved in the EU since February 2015 but the FDA's refusal-to-file letter in 2014 had kept the drug from the U.S. market until now. With approval now in hand, US WorldMeds plans to staff 60 sales representatives to accelerate the commercialization of Xadago.
Mirroring its convoluted marketing structure, Xadago also has a checkered development history. Merck KGaA had signed an agreement with Newron in 2006 for Xadago but returned the rights in 2011 due to strategic considerations and a re-prioritization of its R&D pipeline. At the time, Merck KGaA saw the drug's market potential as much more limited than originally anticipated.
Last year, Newron earned €1.7 million in royalties from Zambon for sales of Xadago in European countries, as well as €3 million in license income. According to Newron, Xadago is the first new chemical entity approved for Parkinson's patients with motor fluctuations in over a decade.
- Newron Pharmaceuticals Press release
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