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 and peripheral nervous system, today provides an end of year market update.
Significant progress has been made in 2017 with the approval and launch of Xadago for the treatment of patients with Parkinson’s disease (PD) in the U.S. in July, and its commercialization in 12 European countries. A study with Xadago to demonstrate the reduction of dyskinesia in PD patients with Levodopa Induced Dyskinesia (LID), scheduled to start in 2018, is in planning together with our partner Zambon.
The “Sarizotan Treatment of Apneas in Rett Syndrome” (STARS) study, a potentially pivotal study, now includes patients as young as six years, following approval by the US FDA and health authorities in Italy, Australia, the UK and India. Newron expects to announce the results of this study in 2018. As previously stated, Newron plans to commercialize Sarizotan for Rett syndrome directly in key markets.
Preclinical results indicating glutamate antagonism mechanism of Evenamide, together with clinical results indicating a benefit in patients not responding to atypical antipsychotics as well as plans to evaluate Evenamide in patients with schizophrenia in two studies, have been discussed with a number of European and the Canadian health authorities, with meetings with CHMP and FDA planned for early 2018. Newron intends to initiate one study each in patients with schizophrenia experiencing worsening of psychosis on atypical antipsychotics, and in treatment resistant patients not responding to clozapine. It is estimated that this latter condition affects approximately 20,000 patients in the U.S., thus allowing Newron and/or other mid-sized companies the opportunity to commercialize Evenamide directly.
Newron’s current cash position after completing a private placement in September 2017 is approximately €60m, enabling Newron to fund its planned clinical trials into 2020, well beyond the key inflection points, as well as current and future research and development and other general corporate activities.
About Newron Pharmaceuticals
Newron (SIX: NWRN) is a
biopharmaceutical company focused on the development of novel therapies
for patients with diseases of the central and peripheral nervous system.
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, Switzerland and the USA, and
is commercialized by Newron’s Partner Zambon. US WorldMeds holds the
commercialization rights in the USA. 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 Evenamide as the potential first
add-on therapy for the treatment of patients with positive symptoms of
schizophrenia. For more information, please visit: 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 update 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 announcement is not an offer for sale of securities in the
United States, Canada, Australia or Japan or any other jurisdiction
where such an offer or solicitation would otherwise be unlawful. The
securities referred to herein may not be sold in the United States
absent registration or an exemption from registration under the U.S.
Securities Act of 1933, as amended. Newron does not intend to register
any of its securities in the United States or to conduct a public
offering of its securities in the United States. This document does not
contain or constitute an offer or invitation to purchase or subscribe
for any securities of Newron and no part of this document shall form the
basis of or be relied upon in connection with any contract or commitment
whatsoever.
