Italian pharmaceutical conglomerate Zambon has partnered with Montreal-based Valeo Pharma to bring Xadago (safinamide) to Canada, where 100,000 patients living with Parkinson’s disease (PD) will now have access to this recently approved drug.
Xadago was developed by Italy’s Newron Pharmaceuticals and approved by the U.S. Food and Drug Administration (FDA) last month for use as an add-on therapy to boost the effectiveness of levodopa/carbidopa in Parkinson’s patients.
“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,” Zambon CEO Roberto Tascione said in a press release.
Xadago works by selectively and reversibly inhibiting MAO-B, a form of the MAO enzyme that can degrade several neurotransmitters including dopamine. Lack of dopamine is thought to be a potential cause of Parkinson’s. By halting dopamine degradation in the brain, MAO-B inhibitors help control the disease’s motor symptoms. Xadago can be used as a stand-alone therapy or as an add-on to improve the effects of other drugs such as levodopa, a dopamine precursor.
In clinical trials, Xadago effectively controlled motor symptoms and complications in the short term, with that effect maintained over a two-year period. Results from a 24-month, double-blind study suggest that Xadago shows significant effects on motor fluctuations (ON/OFF time) without increasing the risk of dyskinesia, or involuntary muscle movements.
Researchers associate this effect with its dual mechanism of action, affecting both the dopaminergic and the glutamatergic pathways. And thanks to its high MAO-B/MAO-A selectivity, Xadago can be taken once a day with no diet restrictions.
“On approval, Xadago will be the first new oral treatment in almost 15 years to address this serious condition in Canada,” said Valeo’s president, Steve Saviuk. “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.”
Under terms of the agreement, Valeo will handle all regulatory, sales, marketing, quality and distribution activities in Canada. It will pay Zambon upfront, regulatory and commercial milestone payments and royalties on sales.
Zambon launched Xadago in 11 European countries after the European Medicines Agency authorized its marketing in February 2015; Switzerland’s Swissmedic followed suit in November 2015. Meiji Seika Pharma has the rights to develop and commercialize the compound in Japan and other key Asian markets, while US WorldMeds, based in Louisville, Ky., will commercialize Xadago in the U.S. market.