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 nervous system (CNS) and pain, today announced the receipt of milestone payments linked to the approval of its lead compound Xadago® (safinamide) for the treatment of Parkinson’s disease by the US Food and Drug Administration.
The payments were made by Newron’s partner Zambon, who holds 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, and relate to the 2012 “strategic collaboration and license agreement for safinamide” between Newron and Zambon. Payments totaled EUR11.3 million which under the applicable IFRS rules will be recognized as immediate revenue. Newron is also eligible to receive royalty payments on sales as part of the 2012 agreement.
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, 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. 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 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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