Zambon S.p.A., an international pharmaceutical company strongly committed to the CNS therapeutic area, and Valeo Pharma, a specialty pharmaceutical company dedicated to registering and launching innovative prescription products in Canada, have announced a strategic agreement to commercialize Xadago (safinamide) for the treatment of Parkinson's disease in Canada.
Under the terms of the agreement, Valeo Pharma will be responsible for all regulatory, sales and marketing, quality, and distribution activities in Canada. Valeo Pharma will pay Zambon upfront, regulatory and commercial milestone payments as well as royalties on product sales.
"On approval, Xadago will be the first new oral treatment in almost 15 years to address this serious condition in Canada," said Steve Saviuk, president of Valeo Pharma. "We look forward to bringing this important new treatment option to more than 100,000 Canadians living with Parkinson's, and adding to our growing portfolio of prescription medications addressing major neurodegenerative diseases."
Roberto Tascione, chief executive officer of Zambon said "We are very pleased to have signed our agreement with Valeo Pharma, a company with an excellent track record in bringing innovative products to market. Entering Canada is an important step forward in the acceptance of safinamide for patients with PD already treated with L-dopa or other therapeutic combinations".
Xadago (safinamide) has been launched by Zambon in Germany, Switzerland, Spain, Italy, Belgium, Denmark, Sweden, UK, Luxembourg, the Netherlands and Norway. Zambon S.p.A. holds the global marketing rights for safinamide with the exception of Japan/Asia. Marketing authorization in the EU for safinamide was granted by the EU Commission in February 2015, and by Swissmedic in November 2015. On March 21, 2017 the Food and Drug Administration (FDA) has approved the use of Xadago (safinamide) for the treatment of Parkinson's disease as add-on therapy to levodopa/carbidopa.
Safinamide is a new chemical entity with a unique mode of action including selective and reversible MAO-B-inhibition and blocking of voltage dependent sodium channels which leads to modulation of abnormal glutamate release. Clinical trials have established its efficacy in controlling motor symptoms and motor complications in the short term, maintaining this effect over 2 years. Results from 24 month double-blind controlled studies suggest that safinamide shows statistically significant effects on motor fluctuations (ON/OFF time) without increasing the risk of developing troublesome dyskinesia. This effect may be related to its dual mechanism acting on both the dopaminergic and the glutamatergic pathways. Safinamide is a once-daily dose and has no diet restrictions due to its high MAO-B/MAO-A selectivity. Zambon has the rights to develop and commercialize Xadago globally, excluding Japan and other key Asian territories where Meiji Seika Pharma has the rights to develop and commercialize the compound. The rights tocommercialize Xadago in the USA have been granted to US WorldMeds, by Zambon.