NeuroSearch achieves approval for HuntexilTM as brand name for pridopidine - a novel therapeutic approach for Huntington's disease
25-08-09 kl. 25/8 2009 12:16 | NeuroSearch 3,50 (-0,28%)
Copenhagen, 24 August 2009 - NeuroSearch (NEUR) announces today that the
European Medicines Agency (EMEA) has approved HuntexilTM as the new trade name
for pridopidine (previously designated ACR16), an entirely new medical approach
for the treatment of Huntington's disease.
Planned for market launch in 2011, HuntexilTM (pridopidine) is in late stage
clinical development as a novel treatment for Huntington's disease. NeuroSearch
is committed to developing new and effective therapies for speciality disease
areas of significantly unmet medical needs, and developed Huntexil™ to address
the limited treatment options currently available for Huntington's patients and
their treating physicians. To date, clinical studies have shown HuntexilTM to
have promising effect on a number of the serious symptoms associated with
Huntington's disease. This includes, in particular, a significant improvement
in patients' ability to perform voluntary movements and the ability to walk
with fewer incidents of falls, leading to a better daily functioning and
quality of life.
“At NeuroSearch, we are highly committed to our HuntexilTM programme aiming for
registration and marketing of the product in 2011 as one of the first specific
treatments for patients with Huntington's disease. The estimated total number
of Huntington's patients worldwide is approximately 100,000, and no effective
treatment is currently available for this severe disease. HuntexilTM is one of
the only new Huntington's drugs in late-stage development,” commented Flemming
Pedersen, CEO of NeuroSearch.
Joakim Tedroff, Chief Medical Officer of NeuroSearch Sweden, added:
“We are very excited about the prospects for our product. Huntington's disease
is a devastating neurodegenerative disease causing progressive loss of
previously acquired functions. The results NeuroSearch have generated with
HuntexilTM so far indicate that this drug represents a unique therapeutic
principle with the potential to ameliorate some of the most disabling symptoms
of the disease. It is our hope that Huntexil™ will help patients regain
abilities lost by the disease, making their everyday life easier.”
The pivotal development programme for HuntexilTM comprises two ongoing clinical
studies; a six-month European Phase III study, MermaiHD, and a three-month
North American study, HART. Both studies are randomised, double-blind and
placebo-controlled evaluating the efficacy, safety and tolerability of two
different HuntexilTM dosing regimens. NeuroSearch has finished recruiting
patients to MermaiHD which, with more than 430 patients enrolled, is the
largest European Huntington's disease study to date. The HART study is still
recruiting.
Both studies are progressing well, and HuntexilTM appears to be well-tolerated.
To date, approximately 90% of the patients who have completed randomised
treatment in MermaiHD have chosen to continue treatment with HuntexilTM in a
six month, open-label extension study.
Huntexil™ has been registered as a new trademark in Denmark and NeuroSearch is
now seeking registration of HuntexilTM in other relevant jurisdictions,
including the European Union and North America.
Contact persons:
Flemming Pedersen, CEO, telephone +45 4460 8214 or +45 2148 0118
Joakim Tedroff, Chief Medical Officer for NeuroSearch Sweden,
telephone +46 707 601 691
Hanne Leth Hillman, Vice President, Director of Investor & Capital Market
Relations, telephone: +45 4460 8212 or +45 4017 5103
About pridopidine (HuntexilTM)
Pridopidine is a dopaminergic stabiliser and the first product in a novel class
of drug candidates with this unique mechanism of action.
Preliminary studies show that pridopidine acts with a higher affinity for D2
receptors when dopamine is already bound to the receptor, i.e. when the
receptor is in an activated state, differentiating pridopidine from D2 receptor
antagonists. Dopaminergic stabilisers also differ from D2 receptor agonists
(agents that stimulate receptor responses) in that they display no intrinsic
activity at D2 receptors.
Initial findings from in vivo animal studies and Phase II clinical trials
suggest that pridopidine may offer clinical benefits for conditions that arise
from dopaminergic dysfunction, such as Huntington's disease, Parkinson's
disease and schizophrenia. Given its mechanism of action, pridopidine may also
offer the additional benefit of having only little or no physiological effects
when dopamine levels are normal, indicating a superior safety profile compared
to existing neuroleptics.
NeuroSearch holds all rights to HuntexilTM, which has received “Orphan Drug”
designation from the health authorities in both the United States and Europe.
About Huntington's Disease
Huntington's disease is a fatal, hereditary neurodegenerative genetic
disorder, which leads to damage of the nerve cells in certain areas of the
brain including the basal ganglia and the cerebral cortex. Patients suffering
from Huntington's disease experience a wide variety of symptoms, including
severe motor disturbances (both lack of voluntary movements and involuntary
movements), cognitive impairment and psychiatric disorders. Symptoms onset is
typically around 35 and 45 years of age and patients hereafter have a life
expectancy of 10 to 15 years.
The disease occurs at a rate of about one in every 10,000 in most western
countries with an estimated 70,000 affected patients in North America and
Europe. In other parts of the world, Huntington's disease prevalence is lower,
and the total number of patients suffering from Huntington's disease outside
North America and Europe is estimated at 30,000 to 35,000. The rate of diagnose
also varies among geographic regions.
After symptoms onset the disease progresses without remission, and eventually
every person afflicted by Huntington's disease will require full-time care.
There is currently no cure or effective treatment for Huntington's disease and
only a limited number of novel drugs in development.
About NeuroSearch
NeuroSearch (NEUR) is a Scandinavian biopharmaceutical company listed on NASDAQ
OMX Copenhagen. The core business of the company covers the development of
novel pharmaceutical agents, based on a broad and well-established drug
discovery platform focusing on ion channels and central nervous system (CNS)
disorders. A substantial share of the activities is partner financed through
strategic alliances with Eli Lilly and Company, Janssen Pharmaceutica and
GlaxoSmithKline (GSK), and a license collaboration with Abbott. NeuroSearch's
pipeline of drug candidates comprises seven clinical (Phase I-III) development
programmes: Pridopidine (ACR16) for Huntington's disease (Phase III),
tesofensine for obesity (Phase III ready), ABT-894 for ADHD (Phase II) in
partnership with Abbott, ACR343 for schizophrenia (Phase II ready), ACR325 to
treat dyskinesias in Parkinson's disease (Phase Ib), , ABT-560 for the
treatment of various CNS disorders (Phase I) in collaboration with Abbott, and
NSD-788 for anxiety/depression (Phase I). In addition, NeuroSearch has a broad
portfolio of preclinical drug candidates and holds equity interests in several
biotech companies.
Skriv en kommentarer til denne artikel:
Send kommentar

Se flere nyheder om NeuroSearch
presse.09-09 - huntexil trademark - uk - final.pdf 



