NeuroSearch initiates clinical Phase I study with NSD-644 as a potential new pain treatment

Announcement


NeuroSearch initiates clinical Phase I study with NSD-644 as a potential new
pain treatment 
- and receives milestone payment under the alliance with GlaxoSmithKline  

NeuroSearch has enrolled and dosed the first healthy volunteers in a clinical
Phase I study with NSD-644 with a view to develop this drug candidate as a new
treatment for pain and other disorders of the central nervous system (CNS).
NSD-644 is being developed under an alliance agreement with GlaxoSmithKline
(GSK), and the initiation of Phase I studies releases a milestone payment to
NeuroSearch of EUR 4 million (DKK 30 million). 

The Phase I study is a randomized, double-blind, placebo-controlled and
sequential dose-escalation study to evaluate the safety and tolerability as
well as the pharmacokinetics of NSD-644. The study will be performed in
Germany. 

For more than a decade, NeuroSearch has been engaged in leading preclinical and
clinical drug discovery in the field of the monoamine neurotransmitters
serotonin, noradrenaline and dopamine. These three neuroransmitters are
critically involved in the regulation of mood, pain and anxiety. NSD-644 is a
novel triple monoamine re-uptake inhibitor, increasing the effect of serotonin,
noradrenalin and dopamine with a potential to treat a range of CNS disorders,
including pain. NSD-644 has demonstrated robust effects in several preclinical
chronic neuropathic pain models supporting this drug candidates' potential use
as a novel analgesic. GSK has accepted NSD-644 as the first development
candidate under the terms of the alliance agreement. 

Under the terms of the agreement with GSK, NeuroSearch retains responsibility
for the clinical development of NSD-644 until completion of Proof-of-Concept
(through Phase IIa), while GSK will be responsible for clinical development
hereafter, as well as for production and marketing of the product. GSK will pay
milestones to NeuroSearch through to market launch as well as double-digit
royalties on global sales of the product. 

The initiation of the Phase I study with NSD-644 and the related milestone
payment from GSK of EUR 4 million does not change NeuroSearch's financial
guidance for 2007 of a loss in the range of DKK 230 - 250 million before
recognition of associates and other equity interests. 


Asger Aamund
Chairman of the Board


Contact persons:

Flemming Pedersen, CEO, telephone: +45 4460 8214 or +45 2148 0118

Hanne Leth Hillman, Vice President, Director of Investor Relations & Corporate
Communications, telephone: +45 4460 8212 or +45 4017 5103 

 
NeuroSearch (NEUR) is a Scandinavian biopharmaceutical company listed on the
OMX Nordic Exchange Copenhagen A/S. Our 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 part of the Company's
activities are partner financed through a broad alliance with GlaxoSmithKline
(GSK) and collaborations with among others Abbott and Astellas. The drug
pipeline comprises 11 clinical (Phase I-III) development programmes: ACR16 in
Huntington's disease (Phase III in preparation), tesofensine in obesity (Phase
III in preparation), NS2359 in depression (Phase II) and ADHD (Phase II) in
partnership with GSK, NS1209 in epilepsy and pain (Phase II), ABT-894 in ADHD
(Phase II) and pain (Phase II) in partnership with Abbott, ACR16 in
schizophrenia (Phase I) in partnership with Astellas, ACR325 in bipolar
disorder and Parkinson's disease (Phase I) and ABT-107 as well as ABT-560 for
the treatment of various CNS diseases - both (Phase I) in collaboration with
Abbott as well as well as NSD-644 (fase I) in collaboration with GSK. In
addition, NeuroSearch has a broad portfolio of preclinical drug candidates and
holds equity interests in several biotech companies.