Biotie Therapies - Company Announcement

Biotie: Tozadenant Phase 2b Parkinson's disease study published in Lancet Neurology

BIOTIE THERAPIES CORP.     STOCK EXCHANGE RELEASE                  8 July, 2014
at 9.10 a.m.


Biotie: Tozadenant Phase 2b Parkinson's disease study published in Lancet
Neurology


Biotie announces that full data from the positive Phase 2b study evaluating
tozadenant, an adenosine A2a antagonist, in Parkinson's disease patients
experiencing end of dose wearing off have been published in Lancet Neurology
(Hauser RA, Olanow CW, Kieburtz KD, et al. Tozadenant (SYN115) in patients with
Parkinson's disease who have motor fluctuations on levodopa: a phase 2b, double-
blind, randomised trial. Lancet Neurol 2014; published online July 7.
http://dx.doi.org/10.1016/S1474-4422(14)70148-6). The Phase 2b study was an
international, randomised, double blind, placebo-controlled, parallel group,
dose finding study in 420 levodopa-treated patients with end of dose wearing off
(i.e at least 2.5 hours off time per day). Patients received either
60mg, 120mg, 180mg or 240mg tozadenant or matching placebo twice daily for 12
weeks.  The primary outcome was a change from baseline to week 12 in hours per
day spent in the off-state, assessed from patient diaries. As previously
disclosed, the study demonstrated that tozadenant, when compared to placebo,
decreased levodopa related motor fluctuations.

Previously released topline results for this study included clinically relevant
and highly statistically improvements in 'off' time, 'on' time, UPDRS part III
and UPDRS parts I-III. In addition to providing more details on these endpoints,
further data published in Lancet Neurology include highly significant
improvements in the clinician global impression of severity and clinician global
impression of improvement in all tozadenant groups compared with placebo and
patient global impression of improvement in the 120 mg BID group. Results of
sensitivity analyses of the primary efficacy outcome using multiple methods were
consistent with the improvements of the primary analysis.

Many patients with Parkinson's disease experience motor fluctuations despite
treatment with available drugs. During this "off-state" the symptoms of
Parkinson's, including rigidity, tremors and difficulty in movement, come back
and can have a significant impact on daily living.  There is a great need for
new drugs that can maintain robust benefits for patients throughout the day or
that can be added to existing treatments to smooth the response without
exacerbating dyskinesias that develop with long term therapy with existing
treatments.

 "This phase 2 study identified doses of tozadenant that were well tolerated and
demonstrated efficacy to reduce off time without increasing troublesome
dyskinesia," noted Robert A. Hauser M.D., Director of the Parkinson's disease
and Movement Disorders Center at the University of South Florida and lead
investigator of the trial. "Tozadenant has the potential to provide benefit for
Parkinson patients who are experiencing fluctuations on levodopa and would be a
welcome addition to our treatment armamentarium. I look forward to similarly
well-executed phase 3 trials.""We are excited that this study has been published in Lancet Neurology, the
highest ranked clinical neurology journal", said Timo Veromaa, President and CEO
of Biotie Therapies Corp. "We are greatly encouraged by the robust data set and
continue to plan aggressively for Phase 3 that will begin in the first half of
2015."

Turku, 8 July 2014

Biotie Therapies Corp.

Timo Veromaa
President and CEO

Further information:

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 tozadenant

Tozadenant is an oral, potent and selective adenosine A2a receptor antagonist
being developed for the treatment of Parkinson's disease. Tozadenant has
displayed clinically relevant and statistically highly significant effects in
Parkinson's disease, across multiple pre-specified evaluation metrics, in a 420
patient Phase 2b study completed in December 2012, and it is currently
transitioning into Phase 3 development.

The preparations for the tozadenant Phase 3 program in Parkinson's disease have
progressed well. These activities include CMC and non-clinical work, and certain
Phase 3 enabling clinical pharmacology studies.

About Biotie

Biotie is a specialized drug development company focused on products for
neurodegenerative and psychiatric disorders. For the past years, Biotie has
successfully operated a strategy built around search, profile and partner. This
has delivered Selincro (nalmefene) for alcohol dependence, which received
European marketing authorization in February 2013 and is currently being rolled
out across Europe by partner H. Lundbeck A/S, and tozadenant, a novel A2a
antagonist which is transitioning into Phase 3 development for Parkinson's
disease and for which Biotie holds exclusive, global rights. Biotie is actively
developing its pipeline assets, including SYN120, a unique potent 5-HT6/5-HT2a
dual antagonist for which Biotie initially expects to conduct a Phase 2 study in
Parkinson's disease dementia that is largely funded by the Michael J Fox
Foundation; nepicastat, a selective inhibitor of dopamine beta hydroxylase which
is currently in a Phase 2 study, fully funded by NIDA, for treatment seeking
cocaine addicts; and BTT-1023, a monoclonal antibody targeting Vascular Adhesion
Protein 1 for which Biotie intends to conduct a Phase 2 study in primary
sclerosing cholangitis, a rare fibrotic disease of the liver. Biotie's shares
are listed on NASDAQ OMX Helsinki.




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