Biotie Presents Tozadenant Phase 2b Data at AAN Annual Meeting

Biotie Presents Tozadenant Phase 2b Data at AAN Annual Meeting 
TURKU, FINLAND -- (Marketwire) -- 03/21/13 --  Biotie announced today
that full data from a Phase 2b study evaluating tozadenant (SYN115)
in Parkinson's disease (PD) patients experiencing levodopa related
end of dose wearing off were presented at the 65th Annual Meeting of
the American Academy of Neurology (AAN) in San Diego, March 20, 2013.
These data were selected by the AAN for the Emerging Science Program
(formerly Late-breaking Science Program) and were presented by Dr. C.
Warren Olanow, Professor of Neurology and Neuroscience at the Mount
Sinai School of Medicine. 
The study was an international, 12-week, double-blind, phase 2 trial
in which patients on stable dosages of levodopa with at least 2.5
hours (hr) of OFF time per day were randomized to tozadenant 60, 120,
180 or 240 mg BID, or matching placebo. The primary outcome measure
was the change from baseline to Week 12 in hours per day spent in the
OFF state. A mixed-model repeated-measures ANCOVA was used for
analyses with a pre-specified hierarchical step-down approach to test
multiple dose groups. 
Of 420 patients randomized, 337 completed treatment. Their mean age
was 63.3 years, mean duration of PD 8.7 years, and their mean OFF
time at baseline was about 6 hr/day. Significant reductions in mean
placebo-corrected change from baseline in OFF time were observed with
tozadenant (modified Intention to Treat population) 120 mg BID (-1.1
hr, p=0.0039) and 180 mg BID (-1.2 hr, p=0.0039). The amount of time
patients spent in the ON time with troublesome dyskinesia was not
significantly increased in any tozadenant group. Mean
placebo-corrected scores on the Unified Parkinson's Disease Rating
Scale (UPDRS) part III significantly improved with tozadenant 120 mg
BID (-2.2, p=0.0325) and 180 mg BID (-2.5, p=0.0325), and mean
placebo-corrected UPDRS I-III scores improved significantly in all
tozadenant groups (all groups, p < 0.03) The changes were also
perceptible to both physicians and patients, as reflected in
statistically significant improvements on global ratings. Mean
placebo-corrected scores on the clinician-administered global
impressions of severity (CGI-S) and improvement (CGI-I) improved
significantly in all tozadenant groups, and placebo-corrected scores
on patient ratings (Patient Global Impression; PGI) significantly
improved in the 120 mg BID group. The most common adverse events in
the combined tozadenant groups were dyskinesia, nausea, dizziness,
constipation, PD worsening, insomnia and falls. 
Steve Bandak, Chief Medical Officer of Biotie stated, "We are very
pleased that these data were selected for inclusion in AAN's Emerging
Science Program and believe it reflects the scientific importance of
these findings and the potential opportunity for tozadenant as a new
treatment for Parkinson's disease". He continued, "We are now working
closely with our partner UCB Pharma for further development of
tozadenant and plan to start the phase 3 program by H1 2015".  
Turku, 21 March 2013 
Biotie Therapies Corp. 
Timo Veromaa
 President and CEO 
 NASDAQ OMX Helsinki
 Main Media 
Tozadenant is an orally administered, selective inhibitor of the
adenosine 2a (A2a) receptor being developed initially for the
treatment of Parkinson's disease. A2a receptors are expressed in high
concentration in the striatum of the brain and are thought to play an
important role in regulating motor function. Tozadenant blocks the
effect of endogenous adenosine at the A2a receptors, resulting in the
potentiation of the effect of dopamine and inhibition of the effect
of glutamate at the mGluR5 receptor. Biotie has granted UCB Pharma
S.A. a license for exclusive, worldwide rights to tozadenant. 
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(TM) (nalmefene), licensed to
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. 
For further information, please contact:
Dr. Stephen Bandak
Chief Medical Officer
tel. +1 650 296 0946 (Pacific Time zone)
Virve Nurmi
Investor Relations Manager
tel. +358 2 274 8900
Press spacebar to pause and continue. Press esc to stop.