KIRKLAND, QC, April 11, 2017 /CNW Telbec/ - Manitex
Capital Inc. (TSXV: MNX) announces that its affiliate, Valeo Pharma
Inc,. has entered into a partnership with Zambon S.p.A. for the
exclusive Canadian rights to commercialize the new Parkinson's
disease product Xadago® (safinamide) in Canada. World Parkinson's Day is observed
every year on April 11 to commemorate
the birthday of Dr. James Parkinson,
the English physician who first described the symptoms of the
disease. Today marks 200 years since
the publication of his seminal 1817 work "An Essay on the
Shaking Palsy".
The full text of the press release from Zambon and Valeo
Pharma is as follows:
Valeo Pharma and Zambon form partnership for
Parkinson's Disease Treatment Xadago® (safinamide) in Canada
- Valeo Pharma and Zambon announce a partnership in Canada which grants Valeo Pharma exclusive
rights to commercialise Zambon's Parkinson's disease product,
licensed from Newron
- New treatment option for estimated 100,000 Canadians living
with Parkinson's disease
- Xadago® (safinamide) has been launched in the European Union,
Switzerland, and it has recently
been approved by the U.S. Food and Drug Administration in the
U.S.A.
- Valeo Pharma to be responsible for registering and launching
Xadago® in Canada
April 11, 2017 – 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,
today 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 to 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 Parkinson's disease
PD is the second most common
chronic progressive neurodegenerative disorder in the elderly after
Alzheimer's disease, affecting 1-2% of individuals aged ≥ 65 years
worldwide. The prevalence of the PD market is expected to grow in
the next years due to the increase in the global population and
advancements in healthcare that contribute to an aging population
at increased risk for PD. The diagnosis of PD is mainly based on
observational criteria of muscular rigidity, resting tremor, or
postural instability in combination with bradykinesia. As the
disease progresses, symptoms become more severe. Early-stage
patients are more easily managed on L-dopa. L-dopa remains as the
most effective treatment for PD, and over 75% of the patients with
PD receive L-dopa. However, long term treatment with L-dopa leads
to seriously debilitating motor fluctuations, i.e. phases of normal
functioning (ON-time) and decreased functioning (OFF-time).
Furthermore, as a result of the use of high doses of L-dopa with
increasing severity of the disease, many patients experience
involuntary movements known as L-dopa-Induced Dyskinesia (LID). As
the disease progresses, more drugs are used as an add-on to what
the patient already takes, and the focus is to treat symptoms while
managing LID and the "off-time" effects of L-dopa. Most current
therapies target the dopaminergic system that is implicated in the
pathogenesis of PD, and most current treatments act by increasing
dopaminergic transmission that leads to amelioration of motor
symptoms.
References:
BMC Oertel. European Handbook of Neurological Management, Vol1,
Chapter 14 & 15, 2011.
NICE PD guideline, 2006.
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
About Newron Pharmaceuticals
Newron (SIX: NWRN) is a
biopharmaceutical company focused on the development of novel
therapies for patients with diseases of the central nervous system
(CNS) and pain. The Company is headquartered in Bresso near
Milan, Italy, with a subsidiary in
Morristown, NJ, USA. Xadago®
(safinamide) has received marketing authorization for the treatment
of Parkinson's disease in the European Union, Switzerland and the USA, and is commercialized by Newron's partner
Zambon. US WorldMeds holds the commercialization rights in the
USA. In addition to Xadago® for
Parkinson's disease, Newron has a strong pipeline of promising
treatments for rare disease patients at various stages of clinical
development, including sarizotan for patients with Rett syndrome
and ralfinamide for patients with specific rare pain indications.
Newron is also developing Evenamide as the potential first add-on
therapy for the treatment of patients with positive symptoms of
schizophrenia. www.newron.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.