2015-07-21 08:00:00 CEST

2015-07-21 08:01:17 CEST


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Biotie Therapies - Company Announcement

Biotie announces start of tozadenant Phase 3 Study in Parkinson's disease


BIOTIE THERAPIES CORP.     STOCK EXCHANGE RELEASE                 21July 2015 at
09.00 a.m.

Biotie announces start of tozadenant Phase 3 Study in Parkinson's disease

Biotie (Nasdaq Helsinki BTH1V; NASDAQ: BITI) announces the start of the Phase 3
clinical study of tozadenant, an investigational adenosine A2a receptor
antagonist, in patients with Parkinson's disease (PD) experiencing levodopa
related end-of-dose "wearing-off".

The Phase 3 study (TOZ-PD) is a randomized, double-blind, placebo controlled
trial that will evaluate efficacy and safety of tozadenant compared to placebo
in 450 PD patients experiencing end-of-dose wearing off episodes. Participants
will be randomized to receive twice daily doses of 60 mg or 120 mg 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
placebo-controlled period will be followed by a 52 week open label treatment
period to collect additional safety data. As previously announced, Biotie
Therapies reached agreement with the U.S. Food and Drug Administration (FDA) on
a Special Protocol Assessment (SPA)  of this study.

A successful outcome to the study will confirm the safety and efficacy observed
in the previously completed Phase 2b study of tozadenant in this indication and
provide a second pivotal study to support submission of an New Drug Application
(NDA) for the use of tozadenant as adjunctive treatment to levodopa in patients
experiencing end-of-dose wearing off.

Based on current estimates, top-line data from the double-blind portion of the
study is expected to be available by the end of 2017.

Timo Veromaa, President and CEO of Biotie, commented: "A significant number of
patients with Parkinson's disease continue to suffer debilitating "off"
episodes, despite therapy with existing PD drugs. Tozadenant promises to bring
the first new mechanism of action in the treatment of PD for nearly twenty years
and we are excited to commence this Phase 3 trial. Thanks to the existing and
new shareholders who participated in our recent capital increase, we are in a
strong financial position to advance tozadenant through the regulatory process
and make it available to patients to address this significant unmet medical
need".

Turku, 21 July 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 endpoints, 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 the study will be accepted as one of the two
pivotal studies required for registration in the United States.

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 in 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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