Newron Pharmaceuticals And Zambon Release: Swissmedic Approves Xadago (Safinamide) For Use In Parkinson’s Disease
MILAN--(BUSINESS WIRE)--Zambon S.p.A., an International Pharmaceutical Company with a strong commitment in central nervous system (CNS) diseases, and its partner Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel CNS and pain therapies, today announced that Swissmedic on November 12, 2015, has approved Xadago® (safinamide) as add-on therapy to levodopa (L-dopa) alone or in combination with other PD therapies for patients with Parkinson’s disease in mid-to late-stage and motor fluctuations.
“We are delighted that PD patients in Switzerland will now have access to this innovative treatment offering unique benefits.”
The approval in Switzerland was preceded by the marketing authorization throughout the European Union by the Commission of the EU, in February 2015. Xadago was also accepted for review by the US FDA and has a current PDUFA date of March 29, 2016.
Maurizio Castorina, CEO of Zambon, stated: “This approval by Swissmedic is a further evidence of the acceptance of the benefits offered by Xadago® (safinamide) by another regulatory authority. We keep on working to ensure this new chemical entity will be available to all the patients in need of innovative therapies in Parkinson’s Disease.”
Stefan Weber, CEO of Newron, added: “We are delighted that PD patients in Switzerland will now have access to this innovative treatment offering unique benefits.”
About Xadago® (Safinamide)
Safinamide is a new chemical
entity with a unique mode of action including selective and reversible
MAO-B-inhibition, use-dependent Na channels blockade and Ca channels
modulation which lead to modulation of abnormal glutamate release.
Clinical trials have unequivocally established its efficacy in
controlling motor symptoms and motor complications in the short term,
maintaining this effect also in the long term (over 2 years). Results
from long-term (24 months) double-blind controlled studies suggest that
safinamide shows significant effects on motor fluctuations (ON/OFF time)
without increasing the risk of developing troublesome dyskinesia. This
positive effect may be related to its dual mechanism acting on both the
dopaminergic and the glutamatergic pathways. Safinamide is well
tolerated with a favourable side-effect profile and is easy to use:
once-daily dose, no need of LD adjustment, no major drug–drug
interactions, no diet restrictions due to its higher MAO-B/MAO-A
selectivity.
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 Parkinson’s disease. 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.
There is a growing belief that targeting non-dopaminergic systems may
lead to improvements in PD symptoms such as dyskinesia that are not
improved by current dopaminergic therapies.
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 productes 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. Marketing
authorization in the EU for Xadago® (safinamide) for the
treatment of Parkinson’s disease was granted by the EU Commission in
February 2015, followed by the launch by Zambon in the first key EU
country - Germany - in May 2015. The New Drug Application (NDA) has been
accepted for review by the FDA, as reported in March 2015. In March
2014, Zambon, Newron’s partner, submitted an MAA to Swissmedic. Zambon
has the rights to develop and commercialize safinamide globally,
excluding Japan and other key Asian territories, where Meiji Seika has
the rights to develop and commercialize the compound. Newron’s
additional projects are based on highly promising treatments for rare
disease patients and are at various stages of clinical development. They
include sarizotan for patients with Rett syndrome, for which Newron
received Orphan Drug Designation in both the US and the EU, ralfinamide
for patients with specific rare pain indications, and NW-3509 as
potentially the first add-on therapy for the treatment of patients with
positive symptoms of schizophrenia. For additional information, please
visit http://www.newron.com.
Contacts
Media
Zambon
Luca Primavera, +39 02 66524491
Mobile:
+39 335 7247417
luca.primavera@zambongroup.com
or
Weber
Shandwick
Giovanna Giacalone, +39 3497738681
ggiacalone@webershandwick.com
or
Weber
Shandwick
Germana Mancino, +39 3492625439
Email: gmancino@webershandwick.com
or
Newron
Stefan
Weber, +39 02 6103 46 26
CEO
pr@newron.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
David
Connolly, +1-617-374-8800, Ext. 108
dconnolly@lavoiehealthscience.com
or
Investors
and Analysts
Newron
Stefan Weber, +39 02 6103 46 30
CEO
ir@newron.com
or
Germany
MC
Services AG
Anne Hennecke, +49 211 52925222
anne.hennecke@mc-services.eu
or
U.S.
LaVoieHealthScience
Kristina
Coppola, +1-617-374-8800, Ext. 105
kcoppola@lavoiehealthscience.com