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, and its partner Zambon S.p.A., an international pharmaceutical company strongly committed to the central nervous system (CNS) therapeutic area, today acknowledge and support World Parkinson’s Disease Awareness Day. In addition, the companies re-state their commitment to the ongoing approvals and launches of Xadago® (safinamide) for the treatment of Parkinson’s disease in the EU, the US and, through Newron’s partner Meiji Seika, in Japan and certain Asian countries. In Switzerland, Germany, Spain, Italy and Belgium, Xadago® (safinamide) is available as add-on therapy to levodopa (L-dopa) alone or in combination with other PD therapies for mid-to late-stage fluctuating patients.
Maurizio Castorina, CEO of Zambon S.p.A., said: “Our efforts in bringing to patients with PD an innovative treatment like Xadago® (safinamide) are being rewarded by the positive feedback that we have received from clinicians and patients in the countries where we have launched to date. We look forward making Xadago® available to more patients in need of a new therapeutic option.”
“With an estimated 6.3 million* people with Parkinson’s disease worldwide, it is truly rewarding to have developed the first New Chemical Entity (NCE) in 10 years to receive a Marketing Authorization from the EU Commission for the treatment of Parkinson’s disease. We look forward to patients around the world with Parkinson’s disease having access to this important therapeutic option,” said Stefan Weber, CEO of Newron Pharmaceuticals.
Lizzie Graham, Executive Director of the European Parkinson’s Disease Association (EPDA), commented: “The EPDA welcomes the work being done by Newron and others in bringing new treatments to improve the lives of people with Parkinson’s disease and their families.”
*European Parkinson’s Disease Association (EPDA) www.epda.eu.com
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 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), Bresso /
Italy, is a biopharmaceutical company focused on the development of
novel therapies for patients with diseases of the central nervous system
(CNS) and pain. Xadago® (safinamide) has received marketing
authorization for the treatment of Parkinson’s disease in the European
Union and Switzerland and is commercialized by Newron’s Partner
Zambon. US WorldMeds holds the commercialization rights in the US. Meiji
Seika has the rights to develop and commercialize the compound in Japan
and other key Asian territories. 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.
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.
