Zambon – central nervous system therapeutics

  • Zambon is announcing today the availability and reimbursement on
    the Italian market of Xadago® (safinamide) as an add-on to levodopa
    alone or in combination with other Parkinson’s Disease (PD) medications
  • Xadago® (safinamide) is the result of the Italian research
    excellence

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”), a research and
development company focused on novel CNS and pain therapies, today
announced the launch of Xadago® (safinamide) in Italy for the treatment
of mid- to late-stage Parkinson’s disease (PD). Following the launch in
Switzerland, Germany and Spain, Xadago® (safinamide) is now available in
Italy as 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.
Zambon - newron - central nervous system therapeutics

Prof. Fabrizio Stocchi from IRCSS S. Raffaele, Rome, declared that “safinamide
represents an important option for patients with PD already treated with
L-dopa alone or with other therapeutic combinations. Its dopaminergic
and non dopaminergic properties introduce a novelty within the drugs for
PD treatment.”
Prof. Stocchi added: “Safinamide has been
demonstrated to significantly increase on time with no, or
non-troublesome dyskinesias in addition to an improvement of motor
functions (UPDRS III).
Studies performed in patients on L-Dopa
have demonstrated its efficacy in benefiting both short-term (6 months)
and long-term (up to 24 months) quality of life outcomes. Safinamide has
been investigated in double blind, placebo-controlled studies of up to
24 months’ duration, where it showed a good safety profile with
maintenance of the clinical benefits
.”

Maurizio Castorina, CEO of Zambon S.p.A. said: “The launch of
Xadago® in Italy makes us particularly proud because it is the result of
Italian research excellence and a major step forward in the treatment of
this progressive disease. We are committed to developing innovative
therapies for patients suffering from PD and other central nervous
system diseases and we look forward to launching this new chemical
entity in other European countries in the near future.”

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. The New Drug Application (NDA) for Xadago® to the US
FDA was accepted for filing by the US FDA, PDUFA date is March 29, 2016.
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.

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 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 S.p.A. 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, including sarizotan for patients with Rett
syndrome and ralfinamide for patients with specific rare pain
indications. Newron is also developing NW-3509 as the potential first
add-on therapy for the treatment of patients with positive symptoms of
schizophrenia.
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”,
“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.
Contacts – Zambon – central nervous system therapeutics 

Media
Zambon
Luca Primavera – CCO, +39 02
66524491
Mobile: +39 335 7247417
luca.primavera@zambongroup.com
or
Zambon Italy
Milva
Naguib, +39 02 66524095
Mobile: +39 3459215675
milva.naguib@zambongroup.com
or
Zambon Newron
Stefan
Weber – CEO, +39 02 6103 46 30
ir@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
Zambon U.S.
LaVoieHealthScience
David
Connolly, +1-617-374-8800, Ext. 108
dconnolly@lavoiehealthscience.com
or
Investors
and Analysts

Newron
Stefan Weber – CEO, +39 02 6103
46 30
ir@newron.com
or
Zambon 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

Zambon – central nervous system therapeutics