Biotie Therapies - Company Announcement

Biotie announces start of clinical study with nepicastat (SYN117) in cocaine dependence

Biotie announces start of clinical study with nepicastat (SYN117) in cocaine    
dependence                                                                      

BIOTIE THERAPIES CORP.     STOCK EXCHANGE RELEASE     10 May 2013 at 9.00 a.m.  
Biotie announces start of clinical study with nepicastat (SYN117) in cocaine    
dependence                                                                      
Biotie Therapies today announced the start of a Phase 2 clinical study          
evaluating nepicastat (SYN117) in cocaine dependence. The National Institute on 
Drug Abuse (NIDA) at the US National Institutes of Health is funding the conduct
of the study under a Collaborative Research and Development Agreement (CRADA)   
signed in December 2011.                                                        
The study is a randomized, double-blind placebo-controlled 11-week trial and is 
expected to enroll about 180 treatment-seeking cocaine-dependent subjects. The  
study will be conducted at approximately 12 US clinics specializing in the      
treatment of drug dependence.                                                   
The trial is expected to take approximately two years to complete.              
Turku, 10 May 2013                                                              
Biotie Therapies Corp.                                                          
Timo Veromaa                                                                    
President and CEO                                                               
For further information, please contact:                                        
Dr. Stephen Bandak, Chief Medical                                               
Officer                                                                         
tel. +1 650 296 0946 (Pacific Time zone), email: stephen.bandak@biotie.com      
Virve Nurmi, Investor Relations Manager                                         
tel. +358 2 274 8900, e-mail:                                                   
virve.nurmi@biotie.com                                                          
Distribution:                                                                   
NASDAQ OMX Helsinki Ltd                                                         
Main Media                                                                      
www.biotie.com                                                                  
ABOUT NEPICASTAT (SYN117)                                                       
Nepicastat is an orally administered, potent and selective inhibitor of the     
enzyme dopamine beta-hydroxylase (DBH) which converts dopamine into             
norepinephrine. Like many other addictions, cocaine dependence is driven by     
dysregulation in the dopamine-reward system. Inhibition of DBH by nepicastat    
increases levels of dopamine, which may reduce craving for cocaine, and reduces 
the levels of norepinephrine, which may decrease the pleasurable responses to   
cocaine and the potential for stress-induced relapse following withdrawal.      
Biotie has previously conducted a placebo-controlled Phase 2a study in          
non-treatment seeking cocaine addicts. The study showed that nepicastat had a   
favourable safety profile and was well tolerated when administered with cocaine.
Nepicastat has also been evaluated as a potential treatment for post-traumatic  
stress disorder (PTSD). In December 2012, Biotie announced top-line data from an
investigator-initiated Phase 2 study in PTSD. In this study, nepicastat was     
generally well tolerated but was not effective in relieving PTSD-associated     
symptoms when compared to placebo. Biotie is evaluating data from this study in 
further detail and will then decide on next steps with nepicastat in PTSD       
Biotie holds full rights to nepicastat and will be able to use data from studies
conducted with NIDA to support future potential regulatory submissions.         
ABOUT BIOTIE                                                                    
Biotie is a specialized drug development company focused on the development of  
drugs for neurodegenerative and psychiatric disorders (e.g. Parkinson's disease,
Alzheimer's disease and other cognitive disorders, alcohol and drug dependence  
(addiction) and post-traumatic stress disorder), and inflammatory and fibrotic  
liver disease. The company has a strong and balanced development portfolio with 
several innovative small molecule and biological drug candidates at different   
stages of clinical development. Biotie's products address diseases with high    
unmet medical need and significant market potential.                            
Biotie's most advanced product, Selincro (nalmefene), licensed to H. Lundbeck   
A/S, has on 28 February 2013 received European marketing authorization for the  
reduction of alcohol consumption in adult patients with alcohol dependence who  
have a high level of alcohol consumption. In addition, Biotie has a strategic   
collaboration with UCB Pharma S.A. covering tozadenant which is transitioning   
into Phase 3 development for Parkinson's disease. Biotie shares are listed on   
NASDAQ OMX Helsinki Ltd.