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, and its partners Zambon S.p.A. and US WorldMeds announced today that the US Food and Drug Administration (FDA) and the Controlled Substance Staff (CSS) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration no longer require Newron to perform any studies to clinically evaluate the potential abuse liability or dependence/withdrawal effects of Xadago®. The FDA decision was communicated during a meeting with Newron that was scheduled following the March 29, 2016 Complete Response Letter (CRL).
The CRL did not require submission of any additional new data/studies/analyses for efficacy or safety in patients with Parkinson’s disease, thus Newron will now expedite re-submission of the New Drug Application (NDA) to the FDA.
Ravi Anand, MD, Newron’s CMO, said: “We thank the FDA and CSS for their help over the last months. Newron’s submission of additional pre-clinical abuse liability studies and additional analyses of the clinical data requested by the CSS led the FDA and CSS to conclude that no further evaluation of the abuse liability or dependence/withdrawal effects of Xadago® were required. Newron and the FDA agreed on the contents of the NDA re-submission which Newron expects to complete by November of this year.”
“We appreciate the exciting development which will allow us to advance the introduction of this potential new treatment option to the one million Americans living with Parkinson’s disease,” said P. Breckinridge (“Breck”) Jones, CEO of US WorldMeds.
“We are very pleased that the FDA has allowed the re-submission of Xadago® in the next months. This reinforces once more our commitment in finding innovative therapies for patients suffering from PD and other Central Nervous System diseases,” said Elena Zambon, President of Zambon.
About Xadago® (safinamide)
Safinamide is a
new chemical entity with a unique mode of action, including selective
and reversible MAO-B-inhibition and blocking of voltage dependent sodium
channels, which leads to modulation of abnormal glutamate release.
Clinical trials have established its efficacy in controlling motor
symptoms and motor complications in the short term, maintaining this
effect over 2 years. Results from 24 month double-blind controlled
studies suggest that safinamide shows statistically significant effects
on motor fluctuations (ON/OFF time) without increasing the risk of
developing troublesome dyskinesia. This effect may be related to its
dual mechanism acting on both the dopaminergic and the glutamatergic
pathways. Safinamide is a once-daily dose and has no diet restrictions
due to its high MAO-B/MAO-A selectivity. Zambon has 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. The rights to develop and commercialize
Xadago® in the USA have been granted to US WorldMeds, by
Zambon.
References:
Two-year,
randomized, controlled study of safinamide as add-on to levodopa in mid
to late Parkinson's disease.
Borgohain, Rupam; Szasz, Jozsef;
Stanzione, Paolo; Meshram, Chandrashekhar; Bhatt, Mohit H et al. (2014).
Movement
disorders : official journal of the Movement Disorder Society vol.
29 (10) p. 1273-80.
Anand R: Safinamide is associated with
clinically important improvement in motor symptoms in fluctuating PD
patients as add-on to levodopa (SETTLE). 17th International Congress of
Parkinson’s Disease and Movement Disorders, Sydney, Australia, June
16-20, 2013.
About Parkinson’s disease
PD is the second most common
chronic progressive neurodegenerative disorder in the elderly after
Alzheimer’s disease, affecting 1-2% of individuals aged ≥ 65 years
worldwide. The prevalence of the PD market is expected to grow in the
next years due to the increase in the global population and advancements
in healthcare that contribute to an aging population at increased risk
for PD. The diagnosis of PD is mainly based on observational criteria of
muscular rigidity, resting tremor, or postural instability in
combination with bradykinesia. As the disease progresses, symptoms
become more severe. Early-stage patients are more easily managed on
L-dopa. L-dopa remains as the most effective treatment for PD, and over
75% of the patients with PD receive L-dopa. However, long term treatment
with L-dopa leads to seriously debilitating motor fluctuations, i.e.
phases of normal functioning (ON-time) and decreased functioning
(OFF-time). Furthermore, as a result of the use of high doses of L-dopa
with increasing severity of the disease, many patients experience
involuntary movements known as L-dopa-Induced Dyskinesia (LID). As the
disease progresses, more drugs are used as an add-on to what the patient
already takes, and the focus is to treat symptoms while managing LID and
the “off-time” effects of L-dopa. Most current therapies target the
dopaminergic system that is implicated in the pathogenesis of PD, and
most current treatments act by increasing dopaminergic transmission that
leads to amelioration of motor symptoms.
References:
BMC Oertel. European Handbook of Neurological
Management, Vol1, Chapter 14 & 15, 2011.
NICE PD guideline,
2006.
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 and Switzerland and is
commercialized by Newron’s Partner Zambon. 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. 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 NW-3509 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.
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 woman
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. The
Group is strongly working on the treatment of the chronic respiratory
diseases as asthma and BPCO and on the CNS therapeutic area with Xadago®
(safinamide) for the Parkinson treatment. Zambon is headquartered in
Milan and was established in 1906 in Vicenza. Zambon is present in 19
countries with subsidiaries and almost 2,700 employees with
manufacturing units in Italy, Switzerland, France, China and Brazil.
Zambon products are commercialized in 84 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.