- FDA endorses the overall Phase III plan for tesofensine in obesity,
including
the filing of an NDA based on 12 months safety and efficacy data


- NeuroSearch will now finalise Phase III preparations and an SPA request
for
submission to the FDA, while continuing discussions with potential
license
partners 


Copenhagen, 8 June 2009 - NeuroSearch announces that it
has successfully
completed the End of Phase II meeting with the United States
Food and Drug
Administration (FDA) for tesofensine, a monoamine reuptake
inhibitor in
development as a novel treatment for obesity (weight management).


In connection with the meeting, the FDA has evaluated tesofensine's
current
data package and the Phase III development plan, and provided input to
the
pivotal programme including the plan to apply for a Special Protocol
Assessment
(SPA) to support the registration of tesofensine in the United
States. 

The main conclusions from the End of Phase II discussions with the
FDA include
the following: 

• The proposed dose regimen of 0.25 mg or 0.5
mg tesofensine daily in Phase III
was endorsed. 

• The proposed pivotal
Phase III programme for tesofensine in weight management
was endorsed by the
FDA and will consist of four placebo-controlled clinical
studies, comprising a
total of approximately 5,700 obese patients with and
without co-morbidities,
such as Type 2 diabetes, hypertension and dislipidemia. 

• Two of the four
trials are powered to show superior weight loss effectiveness
for tesofensine
compared to sibutramine (marketed as Reductil®/Meridia®), and
the aim of
including an adequate wording in the labelling based on final data
was
supported by the FDA. 

• The safety and efficacy assessment within and
across the Phase III studies
and the filing of the New Drug Application (NDA)
for tesofensine for weight
management based on 12 months data were also
endorsed by the FDA. 


Dieter Meier, Executive Vice President and Chief
Medical Officer of NeuroSearch
commented: 
“We are extremely pleased with the
outcome of our End of Phase II meeting with
the FDA, who have been forthcoming
and constructive during our interactions. We
are impressed how the FDA shares
our view on the development of tesofensine,
and we very much look forward to
continuously working with the Agency in our
dedicated efforts to bring this
drug to the market as a more efficacious and
safe anti-obesity treatment.” 


Flemming Pedersen, Chief Executive Officer of NeuroSearch added:
“Obesity
entails a number of very serious and very costly disease conditions,
including
diabetes, metabolic disorders, cardiac complications, arthritis and
cancer,
and we believe tesofensine could effectively contribute to the global
quest
towards improved weight management and potentially also to the treatment
of
diabetes. Tesofensine is one of only very few anti-obesity drugs in late
stage
development, and based on the remarkable results seen in Phase II studies
we
believe it holds immense medical and commercial potential.” 

Earlier results
from a Phase II Proof of Concept study with tesofensine in
obesity, TIPO-1,
has shown a placebo-corrected average weight loss of
approximately 10% after
24 weeks of daily treatment with 0.5 mg tesofensine.
The results from TIPO-1
have been published in The Lancet (The Lancet, Volume
372, Issue 9653, Pages
1906-1913, 29 November 2008) with the conclusion that
tesofensine produces a
weight loss at least twice that of currently approved
anti-obesity drugs. The
safety data base for tesofensine includes more than
1,500 patients having been
exposed to treatment with tesofensine and hereof
more than 1,300 on relevant
dosing. 

Based upon the outcome from the End-of-Phase II meeting with the
FDA,
NeuroSearch will now make final preparations for Phase III and in
parallel
continue discussions with interested partners regarding a license
agreement on
tesofensine. 


Flemming Pedersen
CEO


Contact
persons:
Flemming Pedersen, CEO, telephone: +45 4460 8214 or +45 2148
0118
Hanne Leth Hillman, Vice President, Director of Investor & Capital
Market
Relations, telephone: +45 4460 8212 or +45 4017 5103 


About
NeuroSearch  
NeuroSearch (NEUR) is a Scandinavian biopharmaceutical company
listed on Nasdaq
OMX Copenhagen. The core business of the company covers the
development of
novel pharmaceutical agents, based on a broad and
well-established drug
discovery platform focusing on ion channels and central
nervous system (CNS)
disorders. A substantial share of the activities is
partner financed through
strategic alliances with Eli Lilly and Company and
GlaxoSmithKline (GSK), and
license collaboration with Abbott. The drug
pipeline comprises seven clinical
(Phase I-III) development programmes:
Pridopidine (ACR16) for Huntington's
disease (Phase III), tesofensine for
obesity (Phase III ready), ABT-894 for
ADHD (Phase II) in partnership with
Abbott, ACR325 to treat dyskinesias in
Parkinson's disease (Phase II ready),
ACR343 for schizophrenia (Phase I),
ABT-560 for the treatment of cognitive
dysfunctions (Phase I) in collaboration
with Abbott and NSD-788 for anxiety
(Phase I). In addition, NeuroSearch has a
broad portfolio of preclinical drug
candidates and holds equity interests in
several biotech companies.