Therapy Areas: Respiratory
Onstryv Approved as Parkinson's Treatment in Canada
16 January 2019 - - Onstryv (safinamide) has been approved for the treatment of Parkinson's Disease in Canada, Italian pharmaceutical company Zambon S.p.A. and Canadian specialty pharmaceutical company Valeo Pharma Inc said.

Under the terms of the agreement with Zambon, Valeo Pharma is responsible for all regulatory, quality, sales and marketing, and distribution activities in Canada.

Valeo Pharma expects the Canadian launch of safinamide to occur during the first half of 2019.

Parkinson's Disease is a progressive neurological disease involving the loss of dopamine-producing neurons in the brain. While tremors are the best known symptom, Parkinson's Disease also causes slowed movement, rigid muscles, impaired posture and balance, and speech and writing difficulties.

An estimated 100,000 Canadians are affected, and the number of patients is expected to grow significantly over the next thirty years as the population continues to age.

Safinamide (known as Onstryv in Canada and Xadago in the rest of the world) is a new chemical entity with a mode of action including selective and reversible MAO-B-inhibition.

Clinical trials have established its efficacy in controlling motor symptoms and motor complications in the short term, and data suggest this effect is maintained over two years.

Results from 24 month double-blind controlled studies suggest that safinamide shows effects on motor fluctuations (ON/OFF time) without increasing the risk of developing troublesome dyskinesia.

Safinamide is a once-daily dose and has no diet restrictions due to its high MAO-B/MAO-A selectivity.

Zambon acquired rights from Newron Pharmaceuticals to develop and commercialise Xadago globally, excluding Japan and other key Asian territories where Meiji Seika has the rights to develop and commercialise safinamide.

The rights to develop and commercialise Xadago in the USA have been granted to US WorldMeds, by Zambon.

Two-year, randomised, controlled study of safinamide as add-on to levodopa in mid to late Parkinson's Disease.Borgohain, Rupam; Szasz, Jozsef; Stanzione, Paolo; Meshram, Chandrashekhar; Bhatt, Mohit H et al.

Valeo Pharma is a specialty pharmaceutical company dedicated to the commercialisation of innovative prescription products in Canada.

With a focus on neurodegenerative diseases, woman's health, and oncology and supportive care, Valeo Pharma has a growing portfolio of innovative products and a platform to properly manage these products through all stages of commercialization.

Headquartered in Kirkland, Quebec, Valeo Pharma has all capabilities internally to register and market health care solutions for Canadian patients.

Zambon is a multinational pharmaceutical and fine-chemical company that focuses on innovation and development with the aim to improve the quality of people's health and patients' lives.

Based on a valuable heritage but strongly focused on the future, its goal is to improve people's health through the development of innovative and quality medicines.

Zambon products are commercialised in 86 countries. The company has 20 subsidiaries in three different Continents Europe, America and Asia and owns manufacturing units in Italy, Switzerland, France, China and Brazil.

The company TODAY has a strong focus on the treatment of rare diseases and specialties, such as Parkinson's disease and Cystic Fibrosis, and it's well-established in 3 therapeutic areas: respiratory, pain and women's care.

Zambon was established in 1906 in Italy and TODAY counts around 2,700 employees all over the world.
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