Newron Announces FDA Response to Re-Submitted NDA for Xadago®

- October 21st, 2016

Newron Pharmaceuticals, a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system and pain, and its partners announced today that the FDA considers the September 2016 re-submission of the NDA by Newron to be a complete, Class 2 response to FDA’s March 28, 2016 Complete Response Letter (CRL), and has determined the user fee goal date to be March 21, 2017.

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 partners Zambon S.p.A. and US WorldMeds, LLC, announced today that the US Food and Drug Administration (FDA) considers the September 2016 re-submission of the US NDA by Newron to be a complete, Class 2 response to FDA’s March 28, 2016 Complete Response Letter (CRL), and has determined the user fee goal date (PDUFA date) to be March 21, 2017.
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 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.
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)
disorders : official journal of the Movement Disorder Society
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.
BMC Oertel. European Handbook of Neurological
Management, Vol1, Chapter 14 & 15, 2011.
NICE PD guideline,
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. 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. 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
For more information, please visit:
About US WorldMeds
US WorldMeds is a specialty
pharmaceutical company dedicated to developing, licensing and
commercializing unique and significant specialty pharmaceuticals that
address unmet medical needs or overcome limitations of existing
products. Through sound science and targeted commercialization, the
Kentucky-based company continually strives to identify specialty and
orphan products for diseases with limited patient populations. US
WorldMeds’ portfolio includes Revonto® (dantrolene sodium for
injection) for the treatment of malignant hyperthermia, MYOBLOC®
(rimabotulinumtoxinB) Injection for the treatment of cervical dystonia
in adults and APOKYN® (apomorphine hydrochloride injection)
for the acute, intermittent treatment of hypomobility, “off” episodes
associated with advancing Parkinson’s disease. In addition, US WorldMeds
is working on the development of a non-narcotic drug product
(Lofexidine) for the treatment of opiate withdrawal symptoms. For more
information about US WorldMeds, visit
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’s
health, 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 working on the treatment of the chronic respiratory diseases
such as asthma and COPD and on the CNS therapeutic area with Xadago®
(safinamide) for the treatment of Parkinson’s disease. 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.
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.

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