Biotie's Tozadenant (SYN115) Meets Primary and Multiple

Biotie's Tozadenant (SYN115) Meets Primary and Multiple Secondary
Endpoints in Phase 2b Study in Parkinson's Disease 
Biotie's Tozadenant (SYN115) Meets Primary and Multiple Secondary
Endpoints in Phase 2b Study in Parkinson's Disease 
TURKU, FINLAND -- (Marketwire) -- 12/11/12 --  Biotie today reported
top-line data from a Phase 2b study evaluating its adenosine A2a
antagonist tozadenant (SYN115) in Parkinson's disease (PD) patients
experiencing levodopa related end of dose wearing off. The study met
its primary endpoint of a statistically highly significant decrease
in 'off' time vs. placebo, as well as demonstrating efficacy across
multiple secondary endpoints. Full data from the study will be
disclosed at upcoming medical conferences and in scientific
publications. 
In the 420 patient study, tozadenant displayed clinically relevant
and statistically highly significant effects on PD across multiple
pre-specified evaluation metrics including: a decrease vs. placebo in
'off' time, an increase in 'on' time, an improved score on UPDRS part
III and UPDRS parts I-III combined, as well as improvements on
clinician- and patient-assessed global impression scores.
Additionally, the study identified the minimally efficacious and
maximum feasible dose levels, as well as clinically useful target
doses for Phase 3. Tozadenant was generally well tolerated in the
study. "This trial met all the objectives to be expected of a Phase 2
study", said Dr. Stephen Bandak, CMO of Biotie Therapies Corp. 
Dr. C Warren Olanow, Professor of Neurology and Neuroscience at the
Mount Sinai School of Medicine stated "This important study
demonstrated that the A2a antagonist tozadenant reduced 'off' time in
advanced PD patients. This agent, which does not act directly on the
dopamine system, represents a new class of therapeutic agent that
could be used to aid in the management of patients with this
potentially disabling disorder." 
Dr. Robert Hauser, Professor of Neurology, Molecular Pharmacology and
Physiology at the University of South Florida stated "The patient
reported outcomes indicate that the overall effect of tozadenant was
clinically relevant and provided a meaningful improvement for
patients. These results suggest that tozadenant promises to be a
useful treatment for Parkinson's disease patients experiencing
wearing off fluctuations on levodopa."  
Dr. Karl Kieburtz, Professor of Neurology, Environmental Medicine,
and Community & Preventive Medicine at the University of Rochester
added, "To see such consistent, dose-responsive results in a Phase 2
study, with both patient-reported and physician-based scales showing
meaningful beneficial effects, is both striking and gratifying." 
"We are extremely pleased with the results of this study", said Timo
Veromaa, President and CEO of Biotie Therapies Corp. "The rigor with
which the study was conducted also makes us optimistic that it may be
considered a pivotal study within the envisioned development program.
We look forward to analyzing the results in detail with our license
partner UCB and expect a decision from UCB in the first quarter of
2013 regarding the next steps." 
Turku, 11 December, 2012 
Biotie Therapies Corp. 
Timo Veromaa
 President and CEO 
Distribution:
 NASDAQ OMX Helsinki
Ltd
 Main Media 
About the study (ClinicalTrials.gov identifier: NCT01283594) 
The completed Phase 2b study was a randomized, placebo-controlled,
double-blind dose-finding study conducted in the US, Canada, Chile,
Argentina, Ukraine and Romania. Altogether 420 PD patients
experiencing levodopa related end of dose wearing off were enrolled
into the study. In these patients, treatment with levodopa is
insufficient to control PD symptoms until their next dose, resulting
in an 'off' period when symptoms reappear. 
The subjects were randomized in an even ratio to receive either one
of four dose levels of tozadenant or matching placebo for 12 weeks,
in addition to their standard anti-PD medications. The primary goal
of the study was to determine the efficacy of tozadenant in reducing
the mean number of hours per day spent in the 'off' state. The trial
also assessed the safety of tozadenant and its impact on various
measures of motor symptom severity, dyskinesia and non-motor
symptoms. 
About tozadenant (SYN115) 
Tozadenant is an oral, potent and selective adenosine A2a receptor
antagonist, which enters the brain and modulates regions associated
with motor and non-motor function. Biotie holds a license from Roche
for development and commercialization of tozadenant in all
indications. 
Biotie has granted UCB Pharma S.A. a license for exclusive, worldwide
rights to tozadenant. Pending evaluation of the results of the now
completed Phase 2b study, UCB will be responsible for conducting the
Phase 3 program and commercializing tozadenant. UCB is expected to
take a decision about this in the first quarter of 2013. 
About Parkinson's disease 
Parkinson's disease is the second most common neurodegenerative
disorder, after Alzheimer's disease. It affects about one percent of
people ages 65-69, rising to up to three percent of people who are 80
years and older. The symptoms of Parkinson's disease result from
decreased dopamine production in regions of the brain controlling
movement. 
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 has a strategic collaboration with UCB Pharma S.A. covering
tozadenant for Parkinson's disease. The Marketing Authorization
Application for Biotie's most advanced product, SelincroTM
(nalmefene) for alcohol dependence was filed in the EU by our partner
H. Lundbeck A/S and was accepted for review by the European Medicines
Agency in December 2011. 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)
email: stephen.bandak@biotie.com 
Virve Nurmi
Investor Relations Manager 
tel. +358 2 274 8900
e-mail: virve.nurmi@biotie.com
www.biotie.com 
 
 
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