Date: 2016-03-17
Type of information: Commercialisation agreement
Compound: Xadago™ (safinamide)
Company: Zambon (Italy) US WorldMeds (USA - KY)
Therapeutic area: Neurodegenerative diseases
Type agreement: commercialisation
Action mechanism: Monoamine oxidase inhibitor. Safinamide has a novel dual mechanism of action based on the enhancement of the dopaminergic function (through potent reversible inhibition of MAO-B and of dopamine uptake) and inhibition of excessive release of glutamate.
Disease: add-on therapy to a stable dose of a single dopamine agonist in early Parkinson’s disease patients add-on therapy to levodopa alone or in combination with other Parkinson’s disease treatments in mid-to late stage Parkinson’s disease patients
Details: * On March 17, 2016, Zambon announced a strategic agreement with US WorldMeds to commercialize Newron’s lead compound, Xadago® (safinamide), for the treatment of Parkinson’s disease in the U.S. Zambon S.p.A. holds the global marketing rights for safinamide with the exception of Japan/Asia and has recently begun the commercialization of safinamide under the trade name Xadago® in the EU and Switzerland. The New Drug Application (NDA) for safinamide has been accepted for review by the FDA. US WorldMeds plans to focus more than 60 sales representatives launching Xadago in the U.S.
Marketing authorization in the EU for safinamide was granted by the EU Commission in February 2015, and by Swissmedic in November 2015. Xadago® has been launched by Zambon in Germany, Spain and Italy, as well as in Switzerland. The New Drug Application (NDA) for safinamide has been accepted for review by the FDA with a PDUFA date of March 29, 2016.
Financial terms: Under the terms of the U.S. sub-licensing agreement, US WorldMeds will pay Zambon upfront, regulatory and commercial milestone payments as well as royalties on product sales. Newron Pharmaceuticals will receive from Zambon a milestone payment upon FDA approval and a share of upfront, milestones and royalty payments made by US WorldMeds to Zambon.
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