KIRKLAND, QC, Jan. 15, 2019 /CNW Telbec/ - Manitex Capital
Inc. (TSXV: MNX) announces that its affiliate, Valeo Pharma Inc.,
has received approval from Health Canada for a new Parkinson's
Disease product ONSTRY® (safinamide) in Canada. Valeo Pharma
plans to launch ONSTRYV® in Canada
in the first half of 2019. Already launched in Europe and the U.S.A., ONSTRYV® will provide an important new
option to the estimated 100,000 Canadians living with Parkinson's
Disease.
The full text of the press release from Zambon and Valeo
Pharma is as follows:
Valeo Pharma and Zambon announce the approval of Onstryv®
(safinamide) for Canada
- Valeo Pharma and Zambon previously announced a partnership
which grants Valeo Pharma exclusive Canadian rights to
commercialize safinamide (known as Onstryv® in Canada and Xadago® in the rest of the
world).
- New treatment option for estimated 100,000
Canadians living with Parkinson's Disease.
- Safinamide
has been launched in 13 European countries, Switzerland and the U.S.A., and has recently been approved in
Australia.
Montréal, Qc /CNW Telbec/ January 15,
2019 –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 commercializing innovative
prescription products in Canada,
today announce the approval of Onstryv® (safinamide) for the
treatment of Parkinson's Disease in Canada.
Under the terms of the agreement with Zambon, Valeo Pharma is
responsible for all regulatory, quality, sales and marketing, and
distribution activities in Canada.
"There is a growing need for new treatments to manage
Parkinson's Disease and Onstryv® provides an important option for
patients that require better control of their symptoms. We look
forward to launching the first new oral treatment for Parkinson's
Disease in over a decade to Canadian patients in need of a new
therapeutic choice," said Steve
Saviuk, Chief Executive Officer of Valeo.
Valeo Pharma expects the Canadian launch of safinamide to occur
during the first half of 2019.
Roberto Tascione, CEO of Zambon
said "The approval of safinamide in Canada is a step forward for patients who need
new treatment options for Parkinson's Disease. Our mission
is to make this medication available to as many PD patients
worldwide as possible."
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.
About safinamide
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 2 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
(www.newron.com) to develop and commercialize Xadago®
globally, excluding Japan and
other key Asian territories where Meiji
Seika has the rights to develop and commercialize
safinamide. The rights to develop and commercialize Xadago® in the
USA have been granted to US
WorldMeds, by Zambon.
References:
Two-year, randomized, 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. (2014).
Movement disorders: official journal of the Movement Disorder
Society vol. 29 (10) p. 1273-80.
Anand R: Safinamide is associated with clinically important
improvement in motor symptoms in fluctuating PD patients as add-on
to levodopa (SETTLE). 17th International Congress of Parkinson's
Disease and Movement Disorders, Sydney,
Australia, June 16-20,
2013.
About Valeo Pharma
Valeo Pharma is a specialty
pharmaceutical company dedicated to the commercialization 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. For more information, please visit
www.valeopharma.com
About Zambon
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 commercialized 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. For details on Zambon please visit
www.zambon.com
About Manitex Capital Inc.
Manitex Capital Inc. invests in promising emerging companies in
diversified sectors including life sciences, cleantech and
sustainable products/technologies. Manitex provides its portfolio
companies with specialized corporate finance and advisory services
including corporate strategy, mergers and acquisitions, public
markets access and financing. Common shares of the company are
listed on the TSX Venture Exchange, trading symbol MNX.V.
Neither the TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this news release.
SOURCE Manitex Capital Inc.