Published: 2009-02-23 16:14:38 CET
NeuroSearch A/S - Company Announcement
NeuroSearch announces the results of Phase II Proof of Concept studies with NS2359 in depression
- 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

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

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

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.

fonds.04-09 - ns2359 phase iib results in depression - uk_final.pdf