Biotie Therapies Oyj : Biotie Presents Tozadenant Phase 2b data at AAN Annual Meeting

Biotie Therapies Oyj : Biotie Presents Tozadenant Phase 2b data at AAN Annual


Biotie Presents Tozadenant Phase 2b data at AAN Annual Meeting

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 65^th 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

For further information, please contact:
Dr. Stephen Bandak, Chief Medical Officer
tel. +1 650 296 0946 (Pacific Time zone), email:

Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900, e-mail:


NASDAQ OMX Helsinki Ltd
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


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

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.


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Reuters clients.

The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other
applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of
information contained therein.

Source: Biotie Therapies Oyj via Thomson Reuters ONE
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