NeuroSearch updates on pipeline progress and status


Announcement


NeuroSearch updates on pipeline progress and status

NeuroSearch has a comprehensive and broad development pipeline, counting 19
development programmes with 16 novel drug candidates. All our drug candidates
originate from our in-house drug discovery and represent potentially new and
improved treatment options for a large number of disease indications where
significant unmet medical needs exist - mainly in the field of central nervous
system (CNS) disorders. 

Drug
candidate	
Indication	
Phase	
Partner
ACR16 	Huntington's disease	Phase II/III	Own programme
NS2359	Depression	Phase II	GSK
Tesofensine	Obesity/type 2 diabetes	Phase II	Own programme
NS2359	ADHD	Phase II	GSK
NS1209	Epilepsy, pain	Phase II	Own programme
ABT-894	ADHD	Phase II	Abbott 
ACR16	Schizophrenia	Phase I	Astellas
ABT-894	Neuropathic pain	Phase I	Abbott 
ACR325	Bipolar disorder	Phase I	Own programme
ABT-107	Schizophrenia a.o.	Phase I	Abbott 
ABT-560	Dementia	Preclinical	Abbott
NSD-503	COPD	Preclinical	Own programme
ACR343	Parkinson's disease	Preclinical	Own programme
NSD-551	Brain cancer	Preclinical	TopoTarget
NSD-644	Pain, psychiatric diseases	Preclinical	GSK option
NSD-708	Anxiety	Preclinical	GSK option
NSD-788	Anxiety a.o.	Preclinical	GSK option
NSD-683	CNS diseases	Preclinical	Abbott 
NSD-726	Autoimmune diseases	Preclinical	GSK option

Especially over the past 12-18 months, we have succeeded in growing and
building value to the pipeline, and our drug development programmes continue to
progress in accordance with plans. 

Below is an update on relevant programmes: 

	ACR16 (Huntington's disease) - Ready for Phase III application
With the lead drug candidate ACR16 which is a dopaminergic stabiliser ready for
Phase III application within Huntington's disease, we have concluded six
months' toxicology studies. The results from these studies are satisfactory,
confirming earlier tolerability and safety data, and thus allowing us to
conduct clinical Phase III studies. 

At the beginning of June, we have held a pre-IND meeting with the FDA (the US
regulatory authorities). The outcome encourages us to submit an IND and to
pursue clinical development of ACR16 for Huntington's disease in the US. Also,
we have supportive discussions ongoing with EMEA (the European regulatory
authorities) in preparation for Phase III initiation in Europe. 

We expect to file for the necessary regulatory approvals during the summer
period with a view to initiating a clinical Phase III programme with ACR16 in
Huntington's disease in the second half of 2007. Further, we maintain our
expectations to apply for market registration of ACR16 in 2009. 

	Tesofensine for Obesity/type 2 diabetes - Clinical Phase II extension study 
NeuroSearch has received regulatory approval and initiated patient dosing in
TIPO-4, an open-label, clinical study with the drug candidate, tesofensine as
an extension to the ongoing clinical Phase II Proof-of-Concept study in obesity
(TIPO-1). In TIPO-4, all patients having concluded six months' treatment in
TIPO-1 with either tesofensine or placebo will be offered another six months of
treatment. The dosing of tesofensine will be 0.5 mg daily for all patients with
the possibility to increase to 1 mg daily according to tolerance and efficacy.
The aim of TIPO-4 is to evaluate tesofensine's continued safety and
tolerability as well as to generate additional observations on maintenance of
effect (weight reduction) for a total of up to 12 months. The patients in
TIPO-4 will follow the same diet and exercise programme as in TIPO-1. 

Results from both our TIPO-1 clinical Phase II Proof-of-Concept study and from
our TIPO-2 metabolic evaluation study are still expected in the second half of
2007. 12 month's data on tesofensine based on the TIPO-4 extension study is
expected in the first half of 2008. 

	NS1209 for Status epilepticus and pain - Clinical results and future plans
NeuroSearch has concluded and evaluated data from two small clinical studies
with NS1209; a Phase IIa study in status epilepticus and a Phase I/II in
neuropathic pain. 

As announced in our interim report for the first quarter of 2007, in the pain
study, NS1209 showed to be significantly superior to placebo in alleviating
some key symptoms of neuropathic pain. Also, patients' rating of overall pain
was significantly improved, while the more stringent primary endpoint did not
reach statistical significance. NS1209 demonstrated a good safety profile and
was well tolerated by all treated patients. Given the small size of the study,
these results are encouraging. 

For the epilepsy study, results were inconclusive due to a small evaluable
study population and too high variations in the individual patients' base
lines. 

We have now made a thorough evaluation of the combined clinical data material
on NS1209 together with developmental requirements going forward. Based upon
this and necessary prioritisation of financial resources and capacity in our
development organization, NeuroSearch has now decided to seek a specialised
partner for the continued development of NS1209. 

	NSD-726 - New development candidate for the treatment of autoimmune diseases
NSD-726 has been chosen as the first development candidate from our ion channel
research programme with autoimmune diseases. The compound has shown promising
effect in preclinical models, and preclinical development will commence as soon
as possible. 
Our alliance partner GlaxoSmithKline has option on NSD-726 under our extended
alliance from November 2006. 

The selection of NSD-726 brings a total of seven new drug candidates being
transferred from our drug discovery platform and into the development pipeline
since the beginning of 2006, which we consider highly satisfactory. 


Asger Aamund
Chairman of the Board


Contact persons:	

Flemming Pedersen, CEO, +45 2148 0118

Hanne Leth Hillman, Vice President, Director of IR & 
Corporate Communications, +45 4017 5103


NeuroSearch is a Scandinavian biopharmaceutical company listed on the OMX
Copenhagen Stock Exchange (NEUR). 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 ten clinical development programmes: ACR16 in Huntington's
disease (Phase III preparation), tesofensine in obesity/type 2 diabetes (Phase
II), 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 I) in partnership with Abbott, ACR16 in schizophrenia (Phase I) in
partnership with Astellas, ACR325 in bipolar disorder (Phase I) and ABT-107 for
the treatment of various CNS diseases (Phase I) in collaboration with Abbott.
In addition, NeuroSearch has a broad portfolio of preclinical drug candidates
and holds equity interests in several biotech companies. 

Attachments

fonds.20-07 - pipeline update - final - uk.pdf
GlobeNewswire

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