[April 28, 2016] |
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Zambon Launches Xadago® (Safinamide) in Denmark and Sweden for Patients with Mid- to Late-Stage Parkinson's Disease
Zambon S.p.A., an international pharmaceutical company strongly
committed to the central nervous system (CNS) therapeutic area, and its
partner 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,
today announced the launch of Xadago® (safinamide) in Denmark and Sweden
for the treatment of mid- to late-stage Parkinson's disease (PD).
Safinamide is a new chemical entity with a unique mechanism of action
(MoA), dopaminergic and non-dopaminergic, providing a balanced control
of motor symptoms and motor complications. It is now available in
Denmark and Sweden as an add-on therapy to a stable dose of levodopa
(L-dopa) alone or in combination with other PD therapies for mid- to
late-stage fluctuating patients.
Associate Prof. M.D. Helle Thagensen from the Neurological Department,
Roskilde University Hospital (Denmark), commented: "Safinamide is a
safe and effective first adjunct therapy in levodopa-treated patients,
improving both major symptoms of PD and providing benefits to mild and
non-mild fluctuating patients who are receiving other concomitant
dopaminergic therapies."
Maurizio Castorina, CEO of Zambon S.p.A. said: "We are pleased that
Xadago® is now available in Denmark and Sweden. This is another
significant milestone for PD patients across the world now able to
benefit from this novel therapy."
With the addition of Denmark and Sweden, Xadago® is now available in
seven countries including Germany, Switzerland, Spain, Italy and Belgium.
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 (News - Alert)/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 territories where Meiji Seika
has the rights to develop and commercialize the compound. 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, Australi, 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 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 woman
care, and is very strongly committed to its entry into the CNS space.
Zambon SpA produces high quality products thanks to the management of
the whole production chain which involves Zach (Zambon chemical), a
privileged partner for API, custom synthesis and generic products. The
Group is strongly working on the treatment of the chronic respiratory
diseases as asthma and BPCO and on the CNS therapeutic area with Xadago®
(safinamide) for the Parkinson treatment. Zambon is headquartered in
Milan and was established in 1906 in Vicenza. Zambon is present in 19
countries with subsidiaries and almost 2,700 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. 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. For more information, please visit: 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",
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herein regarding Newron's strategy, goals, plans, future financial
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View source version on businesswire.com: http://www.businesswire.com/news/home/20160427006404/en/
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