- Funding Set to Accelerate Clinical Development of Novel Medicines
for Rare Central Nervous System Disorders -
MILAN--(BUSINESS WIRE)--Newron Pharmaceuticals S.p.A. (“Newron”), a research and development
company focused on novel CNS and pain therapies, announces that it has
completed a capital increase raising gross proceeds of CHF24.3
million/US$ 25.5 million, following the subscription by institutional
investors of 843,072 newly issued shares. The capital increase was
approved at the Company’s Extraordinary Shareholder’s Meeting on March
24, 2015. Once issued, the new shares will be immediately and freely
tradable.
“The funds raised will enable
us to accelerate the development of sarizotan in Rett Syndrome and of
NW-3509, a highly innovative add-on therapy for schizophrenia, for which
we plan to start a Phase II study in Q3 2015.”
The fundraising was supported by current institutional shareholders and
institutional investors from Europe and the U.S., including Aviva, J.P.
Morgan Asset Management, Investor AB, Sphera Global HealthCare Fund and
Nyenburgh. The subscription price was set at CHF 28.80 per share,
slightly below the closing price of Newron’s shares on April 27, 2015,
of CHF29.60. The net proceeds from the fundraising will be used to
accelerate the development of Newron’s pipeline of innovative CNS
therapeutics, primarily sarizotan for patients with Rett Syndrome, as
well as NW-3509, a novel antipsychotic for patients with positive
symptoms of schizophrenia. Additional compounds in development include
sNN0031 for patients with Parkinson’s disease who no longer respond to
oral therapy and sNN0029 for patients with Amyotrophic Lateral Sclerosis
(ALS).
Stefan Weber, CEO of Newron, commented: “With Xadago®
(safinamide) approved in the EU, where it will shortly be launched in
the first member states by our partner Zambon, and with the U.S. NDA
under FDA review for marketing authorization, Newron’s focus is now on
expediting development of its highly promising CNS orphan compounds for
which it holds the commercial rights. We thank existing and new
shareholders for their support of Newron’s strategy for sustainable
growth.”
Roberto Galli, Newron’s VP Finance, added: “The funds raised will enable
us to accelerate the development of sarizotan in Rett Syndrome and of
NW-3509, a highly innovative add-on therapy for schizophrenia, for which
we plan to start a Phase II study in Q3 2015.”
Closing of the transaction will be subject to customary Italian and
Swiss regulatory requirements. The new shares will be listed and traded
on the SIX Swiss Exchange under the same ISIN as the Company’s existing
shares (ISIN: IT0004147952) on or around May 6, 2015.
Bank am Bellevue and WG Partners acted as advisors to Newron in
connection with the transaction.
About Newron PharmaceuticalsNewron (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. Marketing
authorization in the EU for Xadago® (safinamide) was granted by
the EU Commission in February 2015, following the recommendation by the
Committee for Medicinal Products for Human Use (CHMP) to approve the
compound in the EU on Dec. 19, 2014. The New Drug Application NDA to the
U.S. FDA, as informed early March, has been accepted for filing, after
being re-submitted by Newron on Dec. 26, 2014. In March 2014, Zambon, a
partner of Newron, submitted a MAA to Swissmedic. Zambon has the rights
to develop and commercialize safinamide globally, excluding Japan and
other key Asian territories where Meiji Seika has the rights to develop
and commercialize the compound. Newron’s additional projects are based
on highly promising treatments for rare disease patients and are at
various stages of clinical development, including sarizotan for patients
with Rett syndrome, sNN0031 for patients with Parkinson’s disease,
non-responsive to oral drug treatments, sNN0029 for patients with ALS
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.
Important NoticesThis 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
MediaNewron PharmaceuticalsStefan Weber, CEO, +39 02
6103 46 26pr@newron.comorUK/EuropeFTI
ConsultingJulia Phillips, +44 (0)20 3727 1000orSwitzerlandIRF
CommunicationsMartin Meier-Pfister, +41 43 244 81 40orU.S.LaVoieHealthScienceDavid
Connolly, +1 617-374-8800, Ext. 108dconnolly@lavoiehealthscience.comorInvestors
and analystsNewron PharmaceuticalsStefan Weber, CEO, +39
02 6103 46 30ir@newron.comorU.S.LaVoieHealthScienceKristina
Coppola, +1 617-374-8800, Ext. 105kcoppola@lavoiehealthscience.com
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