Newron provides update on submission plans for safinamide

Newron provides update on submission plans for safinamide

Milan, Italy, November 14, 2012 - Newron Pharmaceuticals S.p.A. ("Newron"), a
research and development company focused on Central Nervous System (CNS) and
pain therapies, reports today that it has completed its initial series of
meetings with European health authorities relating to the results of the
preclinical, CMC, and clinical studies to support registration of safinamide
as add-on therapy for the treatment of both early (non-fluctuating) and
advanced (fluctuating) patients with idiopathic Parkinson's disease (PD).
Safinamide is being developed by Newron and its partners Zambon Pharma S.p.A.
and Meiji Seika Pharma Co. Ltd.

The health authorities agreed with the adequacy of the safinamide program for
preclinical toxicology, CMC, DMPK, and the size of the clinical safety data
base that will be part of the submission. In addition, they provided feedback
on the results of the studies demonstrating statistically significant efficacy
of safinamide as add-on therapy in patients taking a stable dose of a single
dopamine agonist in early PD patients, as measured by the UPDRS Part III
(primary efficacy measure), and on motor fluctuations (measured by ON time;
primary efficacy measure) in patients with advanced PD on levodopa and other
PD treatments. Based on this feedback, Newron will proceed to meet with
additional European health authorities, EMA and FDA to discuss its plans for
global regulatory submission currently expected in second half of 2013.

The efficacy and safety of safinamide as add-on to a stable dose of a single
dopamine agonist was evaluated in patients with early PD in three
placebo-controlled studies (009*, 015*, MOTION), while its therapeutic
benefits as add-on to levodopa and other PD treatments in patients with
advanced PD were studied in two placebo-controlled studies (016*, SETTLE). The
presentation of the results of the recently completed MOTION and SETTLE
studies has been scheduled for the 2013 AAN Annual Meeting, San Diego, USA,
March 16-23, 2013.

* previously reported

About safinamide

Safinamide is an alpha-aminoamide is currently being developed by Newron as an
add-on therapy to dopamine agonists or to levodopa in patients with early or
mid- to late-stage Parkinson's disease (PD). It is believed to have both
dopaminergic and non-dopaminergic activities, including selective and
reversible inhibition of monoamine oxidase B (MAO-B), activity-dependent
sodium channel antagonism and inhibition of glutamate release in vitro.

About Parkinson's disease

Parkinson's disease is a degenerative disorder of the central nervous system
that often impairs the patient's motor skills and speech. Parkinson's disease
belongs to a group of conditions called movement disorders. It is
characterized by muscle rigidity, tremor, a slowing of physical movement
(bradykinesia) and, in extreme cases, a loss of physical movement (akinesia).
The primary symptoms are the results of decreased stimulation of the motor
cortex by the basal ganglia, normally caused by the insufficient formation and
action of dopamine, which is produced in the dopaminergic neurons of the
brain. Secondary symptoms may include high-level cognitive dysfunction and
subtle language problems. Parkinson's disease is both chronic and progressive.
It is estimated that more than 3 million people in the industrialized
countries suffer from Parkinson's disease.

About Newron Pharmaceuticals

Newron (SIX: NWRN) is a biopharmaceutical company focused on novel therapies
for diseases of the Central Nervous System (CNS) and pain. The Company is
headquartered in Bresso near Milan, Italy. Phase III trials of safinamide for
the treatment of Parkinson's disease (PD) have recently been completed. Based
on the phase III results of safinamide, Newron is working to expedite the
global filing of the compound, together with its partners. Zambon Group has
the rights to commercialise safinamide globally, excluding Japan and other key
Asian territories, and Meiji Seika has the rights to develop and commercialise
safinamide in Japan and other key Asian territories. Newron's additional
projects are primarily addressed towards highly promising rare diseases and
are at various stages of preclinical and clinical development, including
sarizotan for Rett's syndrome, ralfinamide for specific pain indications, and
NW-3509 as potential first add-on therapy for the treatment of schizophrenia.
www.newron.com

About Zambon

Zambon is an Italian pharmaceutical and fine-chemical multinational company,
earning a strong reputation over the years for high-quality products and
services. Zambon was established in 1906 in Vicenza, where are based the
Italian fine chemical and pharma plants. The other manufacturing units are in
Switzerland, France, China and Brazil. Zambon is present in 15 countries with
more than 2,500 employees. Zambon Company S.p.A. is the industrial holding of
the group, with Zach (Zambon Chemicals) which is a preferred partner for API,
Custom synthesis and generics products for big pharma companies; with Zambon
S.p.A., the pharma business, which mainly operates in respiratory, pain and
women healthcare; with Z-Cube, the corporate research venture, scouting new
technologies and drug delivery system opportunities. Thanks to privileged
relations with the scientific international community, Zambon is creating
"Open Zone", a research and innovation Scientific Campus in Bresso (Milan).
For details on Zambon see http://www.zamboncompany.com.

For more information, contact:

Media                       Investors and analysts
Italy
Stefan Weber - CEO          Stefan Weber - CEO
Phone: +39 02 6103 46 26    Phone: +39 02 6103 46 30
E-mail: pr@newron.com       E-mail: ir@newron.com
UK/Global media
Julia Phillips
FTI Consulting
Phone: +44 (0) 20 7269 7187
Switzerland
Martin Meier-Pfister
IRF Communications
Phone: +41 43 244 81 40

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.

Press release (PDF)

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