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.
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