Data from TIPO-1, a Phase IIb study with NeuroSearch's novel anti-obesity compound, tesofensine to be presented at ECO 2008, the 16th European Obesity Congress


Investor News                                                                   



Data from TIPO-1, a Phase IIb study with NeuroSearch's novel anti-obesity       
compound, tesofensine to be presented at ECO 2008, the 16th European Congress on
Obesity                                                                         

The principal investigator in the TIPO-1 Phase IIb study, Professor, Dr. Med.   
Sci. Arne Astrup1, Department of Human Nutrition, Faculty of Life Sciences,     
University of Copenhagen, Denmark will present the data, showing that           
tesofensine is a potentially effective and safe treatment for obesity and       
possibly type 2 diabetes. Tesofensine is a monoamine reuptake inhibitor,        
increasing the pre-synaptic levels of serotonin, noradrenalin, and dopamine, and
has been found to produce a dose-dependent weight loss.                         

The data will be presented tomorrow, Friday 16 May at the 16th Annual European  
Congress on Obesity (ECO 2008) from 14th- 17th May in Geneva, Switzerland, in an
oral presentation under the title “The efficacy and safety of tesofensine for   
weight loss in obese subjects. A 24 week randomised, double-blind,              
placebo-controlled Danish multi-centre trial”. In the study, obese patients (ITT
population n = 203; BMI 30-40; age 18-65 years) underwent a two week diet and   
exercise lead-in period followed by a 24 week energy-restricted diet and        
treatment with 0.25 mg, 0.5 mg or 1.0 mg tesofensine or placebo, once daily.    

Results demonstrate that the placebo-subtracted weight loss produced by 0.5 mg  
tesofensine was more than double that produced by currently approved compounds, 
and primarily in the form of body fat (8 out of 11 kg), resulting in an average 
reduction in waist circumference of 10 cm compared to an average loss of 2 cm in
the placebo group. Further, treatment with tesofensine has led to important     
improvements in glucose metabolism and reduced insulin resistance, indicating   
that tesofensine may be able to treat also overweight patients with type 2      
diabetes.                                                                       

Adverse events were generally mild and transient. 12% (n=6) of the TE 0.5 mg    
group dropped out, 25% (n=13) in the placebo group and 29% (n=14) in the TE 1.0 
mg group: 20.4% due to adverse events, vs. 8% in the other groups. At           
therapeutic doses (0.25 mg and 0.5 mg) no statistically significant increases in
blood pressure occurred, while heart rate increased dose-dependently up to      
approx. 7 BPM on average. No cardiovascular signs of potential clinical         
relevance were seen in individual patients.                                

At ECO 2008, there will also be a poster presentation of results from the TIPO-1
study under the title “The effects of tesofensine on body composition in obese  
subjects”. Body composition was assessed by DEXA, waist circumference and       
sagittal diameter, and results indicate that tesofensine is highly effective in 
reducing central obesity.                                                       

Tesofensine may be more effective, with similar or less risk, than currently    
approved drugs and warrants Phase III trials.                                   


Contact persons:                                                                
Flemming Pedersen, CEO, telephone: +45 2148 0118                                
Hanne Leth Hillman, Vice President, Director of IR & Corporate Communications,  
telephone: +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 strategic alliance with         
GlaxoSmithKline (GSK) and collaborations with Abbott and Astellas. The drug     
pipeline comprises 13 clinical (Phase I-III) development programmes: ACR16 in   
Huntington's disease (Phase III), tesofensine in obesity (Phase III in          
preparation), NS2359 in depression (Phase II) and ADHD (Phase II) in partnership
with GSK, 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 (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 (Phase I) in partnership with GSK, ACR343 in Parkinson's disease (Phase I) 
and NSD-788 in anxiety and depression (Phase I). In addition, NeuroSearch has a 
broad portfolio of preclinical drug candidates and holds equity interests in    
several biotech companies.

Attachments

presse.05-08 - tipo-1 presentation at eco - uk.pdf