Zambon S.p.A., an international pharmaceutical company committed to the central nervous system (CNS) therapeutic area, has 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 U.S. Food and Drug Administration (FDA).
“We are really pleased to have signed this agreement for Xadago® with US WorldMeds” said Maurizio Castorina, CEO of Zambon S.p.A “It will help Zambon to fulfill the promise of bringing Xadago to patients with Parkinson’s disease in the United States and highlights once again our commitment to the CNS therapeutic area”.
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. Newron has been the sponsor of the clinical development for safinamide in all major countries of the world excluding Japan. US WorldMeds plans to focus more than 60 sales representatives launching Xadago in the U.S.
“US WorldMeds is thrilled to partner with Zambon and looks forward to introducing Xadago® in the U.S.” said P. Breckinridge (“Breck”) Jones, CEO of US WorldMeds. “Parkinson’s disease has been a significant area of focus for our company for many years, and we look forward to leveraging our expertise in helping bring an exciting, new treatment option to the more than one million Americans with this condition.”
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.
“With US WorldMeds’ focus on and knowledge of Parkinson’s disease, we are confident that patients in the U.S. will have access to another innovative treatment option rapidly once Xadago® is approved,” said Stefan Weber, CEO of Newron Pharmaceuticals.