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NeuroSearch publishes positive and confirmatory results from TIPO-2, a clinical metabolic study with tesofensine for the treatment of obesity

Announcement                                                                    



NeuroSearch publishes positive and confirmatory results from TIPO-2, a clinical 
metabolic study with tesofensine for the treatment of obesity                   

NeuroSearch has finalised a clinical metabolic study (“TIPO-2”) with tesofensine
for the treatment of obesity. TIPO-2 is a randomised, double-blind,             
placebo-controlled study in which 32 overweight volunteers with a BMI (Body Mass
Index) of 28 - 35 were treated for 14 days with either tesofensine (with        
accelerated dosing up to 1 mg exposure) or placebo. The aim of the study was to 
evaluate tesofensine's effect on selected metabolic parameters.                 

Even though the TIPO-2 study was designed with short term treatment and the     
study subjects were urged not to change their lifestyle while in the study (no  
diet and exercise programme), a statistically significant mean weight loss of   
2.2 kg (maximum weight loss of 4.7 kg) was seen in the tesofensine-treated group
compared to a mean weight loss of 0.4 kg in the placebo group.                  

--------------------------------------------------------------------------------
|                                 | Tesofensine          | Placebo             |
--------------------------------------------------------------------------------
| Population (ITT)                | n = 16               | n = 16              |
--------------------------------------------------------------------------------
| Baseline average BMI            | 30.7                 | 31.1                |
--------------------------------------------------------------------------------
| Baseline average weight (kg)    | 102.6                | 102.6               |
--------------------------------------------------------------------------------
| Total body weight loss (kg)     | 2.2                  | 0.4                 |
--------------------------------------------------------------------------------
| Maximum weight loss (kg)        | 4.7                  | 1.5                 |
--------------------------------------------------------------------------------


Professor, Dr. Med. Sci. Arne Astrup*, Head of Department of Human Nutrition at 
the University of Copenhagen Faculty of Life Sciences, lead investigator in     
TIPO-2, commented:   
                                                           
"Normally we don't see any significant weight loss within two weeks' treatment, 
so the findings in TIPO-2 underpin the superiority of tesofensine compared to   
existing weight loss compounds. These results are therefore quite re-assuring   
after the weight loss results seen in the TIPO-1 study."                        

* Arne Astrup holds 425 shares in NeuroSearch A/S                               

The results from TIPO-2 showed no measurable changes in energy expenditure,     
metabolic rate and respiratory quotient while there was an increase in fat      
oxidation in the tesofensine-treated group compared to the placebo-group. Fat   
oxidation is a key aspect of improving insulin sensitivity in obese individuals.
Normally, changes in energy expenditure and metabolic rate correlate with       
changes in body weight and further detailed data evaluation of the relationship 
between the different study endpoints is ongoing. No changes in physical        
activity in either the active group or the placebo group were observed.         

Safety results from TIPO-2 are fully consistent with previous findings, and the 
most frequently reported adverse events in the study were mild to moderate. The 
most prominent adverse events were dry mouth and insomnia. Considering the      
subjects' accelerated exposure to tesofensine these safety results are highly   
confirmatory.                                                                   
                                                                                
NeuroSearch considers the TIPO-2 results highly supportive for the continued    
development of tesofensine both in terms of superior efficacy and safety.       
Notably the fast induced weight loss seen after two weeks of tesofensine        
treatment is important both from a medical point of view and with a view to     
ensuring a high patient compliance.                                             


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 IR & 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. The 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 13 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/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/Parkinson's  
disease (Phase I), ABT-107 as well as ABT-560 for the treatment of various CNS  
diseases - both (Phase I) in collaboration with Abbott, NSD-644 in pain a.o.    
(Phase I) in partnership with GSK and ACR343 in Parkinson's disease (Phase I).  
In addition, NeuroSearch has a broad portfolio of preclinical drug candidates   
and holds equity interests in several biotech companies.
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