MILAN--(BUSINESS WIRE)--Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain, is pleased to note the news from its partner Zambon, that it has entered into a partnership with Valeo Pharma for the Canadian market to provide the 100,000 patients living with Parkinson’s access to Xadago® (safinamide). Canada represents one of the eight major markets.
*World Parkinson's Day (WPD) is observed every year on April 11, the birthday of Dr. James Parkinson, the English physician who first described the symptoms of the disease, in 1817; thus, the 2017 WPD marks 200 years since publication of “An Essay on the Shaking Palsy”.
The full text of the announcement 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, 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.
Newron does not undertake any obligation to publicly up-date or revise forward looking statements except as may be required by applicable regulations of the SIX Swiss Exchange where the shares of Newron are listed.
This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.
