- In two studies in Major Depressive Disorder, NS2359 did not meet the
key
efficacy endpoints 

- The results do not support further development of
NS2359 in depression

NeuroSearch announces that GlaxoSmithKline (GSK) has
evaluated NS2359
(GSK372475), a triple monoamine reuptake inhibitor, in a
Phase II Proof of
Concept (POC) programme for the treatment of Major
Depressive Disorder (MDD).
NS2359 is licensed to GSK under a development
agreement between NeuroSearch and
GSK. 

The Phase II POC programme
consisted of two randomised, double-blinded, placebo
and active controlled
studies, including a total of approximately 900 patients
suffering from Major
Depressive Disorder. Both studies evaluated the efficacy
and safety of
10-weeks treatment with different doses of NS2359 as a novel
anti-depressant.
One study included paroxetine (Paxil®) and the other study
venlafaxine
(Effexor®), both marketed anti-depressants, as active controls.
Both studies
were fully sponsored by GSK. 

Results from the two studies show no
significant difference in efficacy between
NS2359 and placebo based on the key
efficacy endpoints; MADRS (the
Montgomery-Åsberg Depression Rating Scale),
Bech 6-item Scale (subscale of the
HAM-D-17) and IDS-CR (Inventory of
Depressive Symptomatology - Clinicians
Rated). In the studies, both active
controls showed statistically significant
efficacy compared to placebo and in
full consistence with earlier published
efficacy results, demonstrating the
validity of the studies. Further analysis
and evaluation of data from the
studies are ongoing by GSK and the detailed
results are expected to be
published in relevant scientific literature in due
course. 

The Phase II
results do not support further development of NS2359 for the
treatment of
depression. 

NS2359 has been evaluated by NeuroSearch and GSK in a number of
single and
multiple dose Phase I studies and in a Phase II study in adult ADHD
patients
(Attention Deficit Hyperactivity Disorder). GSK will now consider
other
potential developmental options to pursue for NS2359. 

Flemming
Pedersen, CEO of NeuroSearch, comments;
“GSK has designed and conducted the
NS2359 POC programme in Major Depressive
Disorder in a highly professional
way. It was based on a well-established
scientific rationale with a supportive
and extensive preclinical and Phase I
clinical data package, so the negative
outcome is disappointing for both
NeuroSearch and GSK. The outcome backs our
strategy of having a broad pipeline
and to partner with large pharmaceutical
companies to share the risk. Until
final decision has been made as to the
developmental route forward for NS2359,
we have decided to exclude the
compound from our drug pipeline.” 

NeuroSearch will disclose financial
guidance for 2009 in connection with the
company's 2008 full year announcement
on 4 March 2009. 


Flemming Pedersen
CEO


Contact persons:
Flemming
Pedersen, CEO, telephone: +45 2148 0118
Hanne Leth Hillman, Vice President,
Director of Investor Relations & Corporate
Communications, telephone: +45 4017
5103 



NeuroSearch  -  Company profile
NeuroSearch (NEUR) is a
Scandinavian biopharmaceutical company listed on Nasdaq
OMX Copenhagen. The
company's core business covers the development of novel
drugs, based on a
broad and well-established drug discovery platform focusing
on ion channels
and CNS disorders. A substantial share of NeuroSearch's
activities is partner
financed through an alliance with Eli Lilly and Company
and collaborations
with GlaxoSmithKline (GSK), Abbott and Astellas. The drug
pipeline comprises
10 clinical (Phase I-III) development programmes: ACR16 for
Huntington's
disease (Phase III), tesofensine for obesity and type 2 diabetes
(Phase III
ready), ABT-894 for ADHD (Phase II) in partnership with Abbott,
ACR16 for
schizophrenia (Phase I) in partnership with Astellas, ACR325 for
Parkinson's
disease (Phase II in preparation) and bipolar disorder (Phase II
in
preparation), ABT-107 and ABT-560 for the treatment of various CNS
disorders -
both (Phase I) in collaboration with Abbott, ACR343 for
Parkinson's disease
(Phase I) 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.