Biotie Therapies - Company Announcement

Biotie announces agreement with FDA on a Special Protocol Assessment for tozadenant Phase 3 study

BIOTIE THERAPIES CORP.     STOCK EXCHANGE RELEASE                 25 May 2015 at
09.00 a.m.

Biotie announces agreement with FDA on a Special Protocol Assessment for
tozadenant Phase 3 study

Biotie Therapies has reached agreement with the U.S. Food and Drug
Administration (FDA) on a Special Protocol Assessment (SPA) for the Phase 3
study of tozadenant in Parkinson's disease (PD). The Phase 3 study (TOZ-PD) will
evaluate efficacy and safety of tozadenant compared to placebo in PD patients
taking levodopa and experiencing end-of-dose wearing off.

A Special Protocol Assessment is a written agreement with the FDA on the design,
size and planned analysis for a clinical trial. An SPA may only be changed
through a written agreement between the sponsor and the FDA, or if the FDA
becomes aware of new public health concerns. A positive outcome of TOZ-PD, along
with the results of the completed Phase 2b study are expected to be sufficient
to support a claim of efficacy for tozadenant in patients with Parkinson's
disease with motor fluctuations (end-of-dose wearing off) and could form the
basis of an NDA submission.  Final marketing approval will be dependent, amongst
other factors, on the overall results of the trial.

The planned study is a randomized, double-blind, placebo controlled Phase 3
study in 450 PD patients experiencing levodopa related end-of-dose wearing off,
in which participants will be randomized to receive twice daily doses of 60mg or
120mg of tozadenant or placebo, in addition to their standard anti-PD
medications, for 24 weeks. The primary endpoint will be reduction in time spent
in the "off" state in patients taking tozadenant as compared to placebo between
baseline and week 24. The double-blind phase of the study will be followed by an
open-label treatment phase of a one year duration.

Timo Veromaa, President and CEO of Biotie, commented: "The agreement with FDA is
another important milestone in our effort to bring tozadenant through the
regulatory process and make it available to patients to address a significant
unmet medical need".

Turku, 25 May 2015

Biotie Therapies Corp.

Timo Veromaa
President and CEO

Further information:

For further information, please contact:

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 (SYN115)

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 significant effects in
Parkinson's disease, across multiple pre-specified evaluation metrics, in a 420
patient Phase 2b study. Full data from the study were published in Lancet
Neurology in July 2014, and it is expected that this successful study will be
accepted as one of the two pivotal studies required for registration in the
United States. Tozadenant is currently transitioning into Phase 3 development as
part of Biotie's proprietary portfolio.

About Biotie

Biotie is a specialized drug development company focused on products for
neurodegenerative and psychiatric disorders. Biotie's development has delivered
Selincro (nalmefene) for alcohol dependence, which received European marketing
authorization in 2013 and is currently being rolled out across Europe by partner
Lundbeck. The current development products include tozadenant for Parkinson's
disease, which is transitioning into Phase 3 development, and two additional
compounds which are in Phase 2 development for cognitive disorders including
Parkinson's disease dementia, and primary sclerosing cholangitis (PSC), a rare
fibrotic disease of the liver.






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