- The primary endpoint, the modified Motor Score, mMS, measuring
voluntary
motor function, showed an improvement of 1.2 points (p= 0.078) 

-
The secondary endpoint, the Total Motor Score, TMS, measuring all
motor
symptoms of the disease, showed an improvement of 2.8 points (p= 0.039)


- A statistically significant dose-response relationship was shown
for
Huntexil® on both the primary (mMS) and the secondary endpoint (TMS) 

-
The results support the good safety and tolerability profile of Huntexil®

-
Results are consistent with the results from the MermaiHD study

-
NeuroSearch will consult with regulatory authorities to define the
best
strategy for obtaining marketing approval for Huntexil® 


Copenhagen,
14 October 2010 - Today, NeuroSearch A/S (NEUR) announced the first
results
from the 12-week randomised, double-blinded, placebo-controlled Phase
II HART
study with Huntexil® (pridopidine), a novel treatment for
Huntington's
disease. 

The HART study was conducted in 28 centres across
the United States and Canada
and enrolled a total of 227 patients, who were
randomised to treatment with
three different doses of Huntexil® (10 mg, 22.5
mg or 45 mg - all twice daily)
or placebo. 

The primary endpoint of the
HART study was the change from baseline at 12-weeks
on the modified Motor
Score, mMS, a subscale of the UHDRS (the Unified
Huntington's Disease Rating
Scale) Total Motor Score, TMS. For the Huntexil® 45
mg twice daily dose group,
the effect versus placebo on the mMS did not reach
significance, but on the
secondary endpoint, the TMS, the change from baseline
at week 12 was
statistically significant. For both the mMS and the TMS, a
statistically
significant improvement in the change from baseline was seen with
increasing
dose, thus demonstrating an important dose-response relationship
for
Huntexil®. 

Importantly, the effect sizes for both the mMS and the TMS
seen in the HART
study are consistent with those seen in the MermaiHD study
(see table): 
 
Table: 	Huntexil® (45 mg twice daily) - effect on mMS and TMS
(mean change
versus placebo; p-value) 

	The HART study*	The MermaiHD study 
at 12 weeks**	The MermaiHD study at 26
weeks*** 
mMS	-1.2 (p= 0.078)	-0.6 (p=
0.2)	-1.0 (p= 0.042)
TMS	-2.8  (p= 0.039)	-2.0 (p= 0.032)	-3.0 (p= 0.004)
*
	ANCOVA (ITT, LOCF) adjustment for baseline score, age, treatment 
** 	MMRM
(ITT, OC) adjustment for baseline score, neuroleptics (yes/no),
gender,
treatment, week and interaction between treatment and week 
***	ANCOVA (ITT,
LOCF) adjustment for baseline score, neuroleptics (yes/no),
gender, treatment


In the HART study, Huntexil® 45 mg twice daily also showed significant
effects
on the patients' balance and gait as well as hand movements. For the
TMS motor
domains for eye movements, dystonia and chorea, positive trends were
observed.
In general, these results also show consistency with the
observations in the
MermaiHD study. 

The endpoints for cognition, affective
symptoms and generalised
function/well-being did not show any statistically
significant changes. 

In the HART study, Huntexil® was found safe and well
tolerated, and the most
frequently reported adverse events across all
treatment groups were falls,
headache, diarrhoea and nausea with no apparent
pattern related to active
treatment. The adverse event findings were
consistent with the observations in
the MermaiHD study. Compliance with study
medication was high across the study. 

Treatment was discontinued due to
adverse events for 7% of patients, and nine
serious adverse events (recurrent
breast cancer, suicidal ideation, depression,
bipolar disorder, adjustment
disorder, testicular torsion and three episodes of
convulsions) were reported
in six patients. No dose-dependent clinical patterns
related to active
treatment were observed. 

Dr. Karl Kieburtz, University of Rochester Medical
Center, Rochester, New York,
the US, Primary Investigator on the HART study,
commented: 

"I find the results of the HART study encouraging as they
provide additional
support for the efficacy of pridopidine (Huntexil®) while
helping also to
demonstrate its benign safety profile in patients with
Huntington's disease.
Pridopidine is the first drug ever to target both the
voluntary and involuntary
motor features of this disease." 

Patrik Dahlen,
CEO of NeuroSearch, added:

"We are highly encouraged by the supportive HART
study outcome and we look
forward to taking the next steps towards our goal of
establishing Huntexil® as
a new and better treatment option for patients with
Huntington's disease." 

NeuroSearch is very encouraged by the strong trend
in improvement on mMS, as
well as the significant improvement on TMS and other
secondary motor endpoints
seen with Huntexil® in the HART study. This,
together with the significant
dose-response relationship on both endpoints
provide strong support to previous
clinical findings, demonstrating that the
drug has beneficial and relevant
effects on core motor functions in patients
with Huntington's disease. Further,
the efficacy of Huntexil has been shown to
be associated with a good safety
profile. 

In the coming weeks, additional
study analyses will be undertaken, including
meta-analyses of data from both
the HART and the MermaiHD studies. When the
evaluation of all available
clinical data is completed, NeuroSearch plans to
engage in dialogue with
regulatory authorities in North America and in Europe
with a view to
discussing the best way forward to obtaining marketing approvals
for Huntexil®
as a novel treatment for Huntington's disease. 
 
NeuroSearch holds all
commercial rights to Huntexil®, and the company is on a
continuous basis
evaluating the best commercial options for the drug in North
America, Europe
and the rest of the world. 

The HART results do not change the company's
financial guidance for 2010 of a
loss before financials and other shares of
results of approximately DKK 350
million. 



Patrik Dahlen	Thomas
Hofman-Bang
CEO		Chairman of the Board



Contact persons
Patrik Dahlen,
CEO, telephone: +45 2629 7296
Hanne Leth Hillman, Vice President, Director of
IR & Corporate Communications,
telephone: +45 4017 5103 


Conference
call
NeuroSearch will host a conference call tomorrow, Friday 15 October,
11:30 am
to 12:00 local time (10:30 to 11:00 am UK time/5:30 to 6:00 am EST)
to further
present and discuss the HART results. Participating in the call
will be CEO
Patrik Dahlen, Dr. Nicholas Waters, CEO of NeuroSearch Sweden AB
and Hanne Leth
Hillman, VP and Director of IR & Capital Market Relations. The
telephone
conference will be conducted in English and the dial-in numbers are:
UK and
International +44 207 509 5139, US +1 718 354 1226 and DK +45 3271
4767. 



About Huntexil® (pridopidine) 
Pridopidine acts as a
dopaminergic stabiliser and is the first compound in a
new class of
pharmaceutical agents, dopidines to have demonstrated clinical
effect.
Dopidines have the unique ability to stabilise the dopaminergic system,
i.e.,
to either enhance or inhibit dopamine dependent functions in the
brain,
depending on the initial level of dopaminergic activity.


Pridopidine inhibits dopamine activation of the D2 receptor with a
preference
towards the high affinity (activated) receptor state and has no
detectable
agonist activity on this receptor. In vivo, pridopidine strengthens
glutamate
function in the frontal cortex, which may add to the agent's
powerful
behavioural effects in states of excessively high dopamine activity
or
excessively low glutamate activity, while not affecting behaviour under
normal
conditions. Together, these findings suggest that pridopidine
stabilises
psychomotor activity in states of hypo- and hyperactivity by means
of
functional D2 antagonism and strengthening of cortical glutamate functions.



About Huntington's disease
Huntington's disease is a highly disabling,
fatal and incurable genetic
disorder, which leads to damage of the nerve cells
in certain areas of the
brain including the basal ganglia and the cerebral
cortex. The disease is
hereditary and every child of someone with Huntington's
disease has a 50%
chance of inheriting the disease. 

Patients with
Huntington's disease experience a wide variety of symptoms, which
typically
can be grouped into three categories: motor dysfunction includes loss
of
muscle co-ordination, parkinsonism, chorea, dystonia, and abnormal gait
and
posture, which can markedly impair patients' daily functioning.
Impaired
executive and cognitive functions lead to loss of organizational and
planning
skills, and psychiatric changes, such as depression and anxiety, are
typical;
manic and psychotic symptoms can also be present. The onset of
symptoms is
typically around 35-45 years of age, after which patients
deteriorate gradually
and have a life expectancy of 10-20 years. 
 
Patients
with Huntington's disease will eventually require full-time care, and
the
therapy area has high unmet medical needs. No cure or effective treatment
is
available and only a limited number of novel drugs are in development.
The
prevalence of Huntington's disease is about 1: 10 000 in most
western
countries, corresponding to an estimated 70 000 affected patients in
North
America and Europe combined. In other parts of the world, the prevalence
varies
substantially and is generally lower. 


About NeuroSearch

NeuroSearch A/S is a leading CNS focused and European based
biopharmaceutical
company listed on NASDAQ OMX Copenhagen A/S (NEUR). The
company's core business
is development of novel drugs to treat diseases of the
central nervous system,
and the pipeline comprises eight products in clinical
development (Phase
I-III). These include Huntexil® (pridopidine), a unique
orphan drug in Phase
III development for the treatment of Huntington's
disease, and tesofensine
ready for Phase III development as a novel drug to
treat obesity. 

NeuroSearch is founded on a well-established drug discovery
platform in the
field of ion channels and monoamine transporters, ensuring the
continuous
production of novel preclinical development candidates. The company
has
strategic drug discovery and development alliances with Janssen
Pharmaceutica
and Eli Lilly as well as a licence collaboration with Abbott.
Further,
NeuroSearch has equity interests in a number of private companies in
the Life
Science industry.