Newron Re-Submits US NDA for Xadago® (Safinamide)

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, LLC, announced today that Newron has re-submitted the New Drug Application (NDA) for Xadago® (safinamide) to the US Food and Drug Administration FDA.
As previously reported, the FDA communicated to Newron in a meeting in
July that clinical studies to evaluate the potential abuse liability or
dependence/withdrawal effects of Xadago® were no longer required. The
meeting had been scheduled following the March 29, 2016 Complete
Response Letter (CRL) by the FDA. The FDA agreed that the re-submission
did not require any new data/studies/analyses for efficacy or safety in
patients with Parkinson’s disease. As a class 2 resubmission, the FDA is
expected to complete its review of the re-submission within 6 months of
acceptance.
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, LLC
US WorldMeds is a specialty
pharmaceutical company dedicated to developing, licensing and
commercializing unique 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, APOKYN^® (apomorphine hydrochloride injection) for
the acute, intermittent treatment of hypomobility, “off” episodes
associated with advancing Parkinson’s disease and CORGARD (nadolol) for
the long-term management of patients with angina pectoris and for the
management of hypertension. In addition, US WorldMeds has a full
pipeline of products under development including the 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 SpA 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
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