NeuroSearch successfully completes End of Phase II meeting with the FDA for tesofensine, a treatment for obesity

- 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.