Industry Press Releases

Valeo Pharma and Zambon Form Partnership for Parkinson’s Disease Treatment Xadago® (safinamide) in Canada

Tuesday, Apr 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, Vol. 1, 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.

Important Notices
This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates and current and future collaborations for the development and commercialisation of its product candidates and reduce costs (including staff costs), (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s anticipated future revenues, capital expenditures and financial resources, and (4) assumptions underlying any such statements. In some cases these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron's strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements.

By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions.

Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron's research programmes, development activities, commercialisation plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions.

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Contacts
Media

Newron
Stefan Weber, +39 02 6103 46 26
CEO
pr@newron.com
or
Zambon
Luca Primavera, +39 02 66524491
Mobile: +39 335 7247417
CCO
luca.primavera@zambongroup.com
or
Italy
Milva Naguib, +39 02 66524095
Mobile: +39 3459215675
milva.naguib@zambongroup.com
or
Valeo Pharma
Steve Saviuk, +1 514-693-8830
President and CEO
saviuk@valeopharma.com
or
UK/Europe
FTI Consulting
Julia Phillips, +44 (0)20 3727 1000
or
Switzerland
IRF Communications
Martin Meier-Pfister, +41 43 244 81 40
or
Germany
MC Services AG
Anne Hennecke, + 49 211 52925222
anne.hennecke@mc-services.eu
or
U.S.
LaVoieHealthScience
Alison Chen, +1 617-374-8800, Ext. 104
achen@lavoiehealthscience.com
or
Investors and Analysts
Newron
Stefan Weber, +39 02 6103 46 26
CEO
pr@newron.com
UK/Europe
FTI Consulting
Julia Phillips, +44 (0)20 3727 1000
Germany/Europe
MC Services AG
Anne Hennecke, + 49 211 52925222
anne.hennecke@mc-services.eu
U.S.
LaVoieHealthScience
Beth Kurth, +1 617-374-8800, Ext. 106
bkurth@lavoiehealthscience.com

 

Source: businesswire.com

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