Newron reports SERENA trial top-line results for ralfinamide

Newron reports SERENA trial top-line results for ralfinamide

Milan, Italy - May 6, 2010 - Newron Pharmaceuticals S.p.A. ("Newron" SIX:
NWRN), a research and development company focused on novel CNS and pain
therapies, today announced top-line results of its SERENA* study, a phase
IIb/III study of ralfinamide in patients with at least moderate Neuropathic
Low Back Pain (NLBP).

The 12-week SERENA study enrolled 411 patients with chronic NLBP of at least
moderate severity and evaluated the safety and efficacy of two dose regimens
of ralfinamide compared to placebo.

Available results on the primary endpoint of the study, the change from
baseline for the 11-point Likert Scale, did not detect any significant
difference between ralfinamide and placebo. Ralfinamide was well tolerated,
with no clinically significant differences from placebo on safety measures.

Further analyses of the additional endpoints (VAS, PGI, CGI etc.)** are
currently ongoing and will be reviewed with Newron's external advisors. Based
on the multiple CNS effects seen in animal pharmacology models, and the
excellent human safety data, Newron will decide how to proceed further with
the compound.

Luca Benatti, Newron´s Chief Executive Officer, commented: "We are extremely
surprised and disappointed by the results, based on the statistically
significant benefits shown in a phase II placebo-controlled trial, as well as
the results from a large number of preclinical studies. We shall be working
with our external advisors to make a complete assessment of the data prior to
determining our next steps, including a review of our development resource
needs going forward. We have a broad portfolio of products in various stages
of development, addressing substantial market opportunities and this, combined
with our existing cash resources and SEDA equity line, gives Newron continued
potential for growth and value generation".

In addition to ralfinamide, Newron has an advanced pipeline of innovative
compounds, that include safinamide, currently in phase III development for the
treatment of Parkinson's disease (add-on treatment for all stages of PD)
together with Merck Serono; NW-3509, an novel treatment for schizophrenia
expected to enter human trials later this year, and HF0220, a potential
disease-modifying therapy for neurodegenerative disorders, currently in phase
II.

* SERENA: Safety and Efficacy of Ralfinamide in nEuropathic low back paiN
pAtients.

** VAS - Visual Analog Scale, PGI - Patient global impression of change, CGI -
Clinical global impression of severity and change

About Newron Pharmaceuticals

Newron Pharmaceuticals S.p.A. (www.newron.com) is a biopharmaceutical company
focused on novel therapies for diseases of the Central Nervous System and
pain. Newron is undertaking phase III trials with safinamide for the treatment
of Parkinson's disease (PD) in conjunction with its partner, Merck Serono,
which has exclusive worldwide rights to develop, manufacture and commercialize
the compound in PD, Alzheimer's disease, and other therapeutic applications.
Newron's additional projects are in various stages of preclinical and clinical
development, including NW-3509 for the treatment of schizophrenia and HF0220
for neuroprotection. Newron is headquartered in Bresso, near Milan, Italy. The
company is listed at SIX Swiss Exchange, trading symbol NWRN.

For more information, contact:

Media                                    Investors and analysts
Italy

Luca Benatti - CEO

Phone: +39 02 6103 4 626

E-mail: pr@newron.com

UK/Global media
                                         Stefan Weber - CFO
Julia Phillips
                                         Phone: +39 02 6103 46 30
Financial Dynamics
                                         E-mail: ir@newron.com
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.

Media release (PDF)

Provider                  Channel         Contact
Tensid Ltd., Switzerland  newsbox.ch      Provider/Channel related enquiries
www.tensid.ch             www.newsbox.ch  marco@tensid.ch
                                          +41 41 763 00 50