Zambon S.p.A., an international pharmaceutical company strongly committed to the central nervous system (CNS) therapeutic area, and Valeo Pharma Inc., a specialty pharmaceutical company dedicated to registering and launching innovative prescription products in Canada 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, CEO 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.
About Xadago® (safinamide)
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.
About Valeo Pharma
Valeo Pharma is a specialty pharmaceutical company dedicated to the registration and launch of innovative prescription products in Canada. With a focus on neurodegenerative diseases, kidney diseases, and hospital products, Valeo Pharma has a growing portfolio of innovative products that includes Synacthen (tetracosactide), partnered with Mallinckrodt Pharmaceuticals, and M-Eslon (morphine sulfate), partnered with Ethypharm. Headquartered in Montreal,
Quebec, Valeo Pharma has a full complement of capabilities to license, register, launch, and market innovative medications for Canadian patients. For more information, please visit www.valeopharma.com.
About Zambon
Zambon is a leading Italian pharmaceutical and fine-chemical multinational company that has earned a strong reputation over the years for high quality products and services. Zambon is well-established in 3 therapeutic areas: respiratory, pain and women’s health, and is very strongly committed to its entry into the CNS space with Xadago® (safinamide) for the treatment of Parkinson’s disease and rare diseases with Promixin® in cystic fibrosis. Zambon is headquartered in Milan
and was established in 1906 in Vicenza. Zambon is present in 19 countries with subsidiaries and almost 2,800 employees with manufacturing units in Italy, Switzerland, France, China and Brazil. Zambon products are commercialized in 84 countries. For details on Zambon please see: www.zambongroup.com
Media
Zambon
Luca Primavera – CCO
Phone: +39 02 66524491
Mobile: +39 335 7247417
Email: luca.primavera@zambongroup.com
Italy
Milva Naguib
Phone: +39 02 66524095
Mobile: +39 3459215675
Email: milva.naguib@zambongroup.com
Valeo Pharma
Steve Saviuk – President and CEO
Phone : +1 514 693-8830
Email : saviuk@valeopharma.com
