http://www.biotie.com/en/investors/s...sItemYear=2012


BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 11 DECEMBER 2012 at 9:00 a.m.

Biotie's tozadenant (SYN115) meets primary and multiple secondary endpoints in phase 2b study in Parkinson's disease

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."