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Wednesday, March 18, 2009

NeuroSearch announces the results of Phase II Proof of Concept studies with NS2359 in depression

Source - Pipeline Review

"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."

– 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

Ballerup, Denmark February 23, 2009 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.

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