Newron provides update on submission plans for safinamide
Milan, Italy, November 14, 2012 - Newron Pharmaceuticals S.p.A. ("Newron"), a
research and development company focused on Central Nervous System (CNS) and
pain therapies, reports today that it has completed its initial series of
meetings with European health authorities relating to the results of the
preclinical, CMC, and clinical studies to support registration of safinamide
as add-on therapy for the treatment of both early (non-fluctuating) and
advanced (fluctuating) patients with idiopathic Parkinson's disease (PD).
Safinamide is being developed by Newron and its partners Zambon Pharma S.p.A.
and Meiji Seika Pharma Co. Ltd.
The health authorities agreed with the adequacy of the safinamide program for
preclinical toxicology, CMC, DMPK, and the size of the clinical safety data
base that will be part of the submission. In addition, they provided feedback
on the results of the studies demonstrating statistically significant efficacy
of safinamide as add-on therapy in patients taking a stable dose of a single
dopamine agonist in early PD patients, as measured by the UPDRS Part III
(primary efficacy measure), and on motor fluctuations (measured by ON time;
primary efficacy measure) in patients with advanced PD on levodopa and other
PD treatments. Based on this feedback, Newron will proceed to meet with
additional European health authorities, EMA and FDA to discuss its plans for
global regulatory submission currently expected in second half of 2013.
The efficacy and safety of safinamide as add-on to a stable dose of a single
dopamine agonist was evaluated in patients with early PD in three
placebo-controlled studies (009*, 015*, MOTION), while its therapeutic
benefits as add-on to levodopa and other PD treatments in patients with
advanced PD were studied in two placebo-controlled studies (016*, SETTLE). The
presentation of the results of the recently completed MOTION and SETTLE
studies has been scheduled for the 2013 AAN Annual Meeting, San Diego, USA,
March 16-23, 2013.
* previously reported
Safinamide is an alpha-aminoamide is currently being developed by Newron as an
add-on therapy to dopamine agonists or to levodopa in patients with early or
mid- to late-stage Parkinson's disease (PD). It is believed to have both
dopaminergic and non-dopaminergic activities, including selective and
reversible inhibition of monoamine oxidase B (MAO-B), activity-dependent
sodium channel antagonism and inhibition of glutamate release in vitro.
About Parkinson's disease
Parkinson's disease is a degenerative disorder of the central nervous system
that often impairs the patient's motor skills and speech. Parkinson's disease
belongs to a group of conditions called movement disorders. It is
characterized by muscle rigidity, tremor, a slowing of physical movement
(bradykinesia) and, in extreme cases, a loss of physical movement (akinesia).
The primary symptoms are the results of decreased stimulation of the motor
cortex by the basal ganglia, normally caused by the insufficient formation and
action of dopamine, which is produced in the dopaminergic neurons of the
brain. Secondary symptoms may include high-level cognitive dysfunction and
subtle language problems. Parkinson's disease is both chronic and progressive.
It is estimated that more than 3 million people in the industrialized
countries suffer from Parkinson's disease.
About Newron Pharmaceuticals
Newron (SIX: NWRN) is a biopharmaceutical company focused on novel therapies
for diseases of the Central Nervous System (CNS) and pain. The Company is
headquartered in Bresso near Milan, Italy. Phase III trials of safinamide for
the treatment of Parkinson's disease (PD) have recently been completed. Based
on the phase III results of safinamide, Newron is working to expedite the
global filing of the compound, together with its partners. Zambon Group has
the rights to commercialise safinamide globally, excluding Japan and other key
Asian territories, and Meiji Seika has the rights to develop and commercialise
safinamide in Japan and other key Asian territories. Newron's additional
projects are primarily addressed towards highly promising rare diseases and
are at various stages of preclinical and clinical development, including
sarizotan for Rett's syndrome, ralfinamide for specific pain indications, and
NW-3509 as potential first add-on therapy for the treatment of schizophrenia.
Zambon is an Italian pharmaceutical and fine-chemical multinational company,
earning a strong reputation over the years for high-quality products and
services. Zambon was established in 1906 in Vicenza, where are based the
Italian fine chemical and pharma plants. The other manufacturing units are in
Switzerland, France, China and Brazil. Zambon is present in 15 countries with
more than 2,500 employees. Zambon Company S.p.A. is the industrial holding of
the group, with Zach (Zambon Chemicals) which is a preferred partner for API,
Custom synthesis and generics products for big pharma companies; with Zambon
S.p.A., the pharma business, which mainly operates in respiratory, pain and
women healthcare; with Z-Cube, the corporate research venture, scouting new
technologies and drug delivery system opportunities. Thanks to privileged
relations with the scientific international community, Zambon is creating
"Open Zone", a research and innovation Scientific Campus in Bresso (Milan).
For details on Zambon see http://www.zamboncompany.com.
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