MILAN--(BUSINESS WIRE)--Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN), a research and development company focused on novel CNS and pain therapies, and its partners Zambon S.p.A. and US WorldMeds announced today that a complete response letter from the FDA has been received for safinamide.
The complete response letter requests clinical evaluation of the potential effect of safinamide on behaviors relating to abuse liability and dependence/withdrawal effects as required by the Controlled Substance Staff (CSS) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration.
Ravi Anand, MD, CMO, said: “The complete response letter does not require submission of any additional new data/studies/analyses for efficacy or safety in patients with Parkinson’s disease. Newron is requesting a meeting with the representatives of the Controlled Substance Staff and Division of Neurological Products to finalize plans for the additional experiments.”
Newron and its partners will provide an update on the potential timelines for approval of safinamide in the near future.
About Newron Pharmaceuticals
Newron (SIX: NWRN), Bresso,
Italy, is a biopharmaceutical company focused on the development of
novel therapies for patients with diseases of the central nervous system
(CNS) and pain. Xadago® (safinamide) has received marketing
authorization for the treatment of Parkinson’s Disease in the European
Union and Switzerland and is commercialized by Newron’s partner Zambon.
The US New Drug Application (NDA) has been accepted for review by the
FDA. US WorldMeds holds the commercialization rights in the US. Meiji
Seika has the rights to develop and commercialize the compound in Japan
and other key Asian territories. Newron’s additional projects are based
on highly promising treatments for rare disease patients and are at
various stages of clinical development. They include Sarizotan for
patients with Rett Syndrome, for which Newron received Orphan Drug
Designation in both the US and the EU, ralfinamide for patients with
specific rare pain indications, and NW-3509 as potentially the first
add-on therapy for the treatment of patients with positive symptoms of
schizophrenia.
About US WorldMeds
US WorldMeds is a specialty
pharmaceutical company dedicated to developing, licensing and
commercializing unique and significant specialty pharmaceuticals that
address unmet medical needs or overcome limitations of existing
products. Through sound science and targeted commercialization, the
Kentucky-based company continually strives to identify specialty and
orphan products for diseases with limited patient populations. US
WorldMeds’ portfolio includes Revonto® (dantrolene sodium for
injection) for the treatment of malignant hyperthermia, MYOBLOC®
(rimabotulinumtoxinB) Injection for the treatment of cervical dystonia
in adults and APOKYN® (apomorphine hydrochloride injection)
for the acute, intermittent treatment of hypomobility, "off" episodes
associated with advancing Parkinson's disease. In addition, US WorldMeds
is working on the development of a non-narcotic drug product
(Lofexidine) for the treatment of opiate withdrawal symptoms. For more
information about US WorldMeds, visit www.usworldmeds.com.
About Zambon
Zambon is a leading Italian pharmaceutical and
fine-chemical multinational company that has earned a strong reputation
over the years for high quality products and services. Zambon is
well-established in 3 therapeutic areas: respiratory, pain and women’s
care, and is very strongly committed to its entry into the CNS space.
Zambon S.p.A produces high quality products thanks to the management of
the whole production chain which involves Zach (Zambon chemical), a
privileged partner for API, custom synthesis and generic products.
Zambon is headquartered in Milan and was established in 1906 in Vicenza.
Zambon is present in 15 countries with subsidiaries and more than 2,600
employees with manufacturing units in Italy, Switzerland, France, China
and Brazil. Zambon products are commercialized in 73 countries. For
details on Zambon please see: www.zambongroup.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.
