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Biotie Therapies Oyj: Biotie provides update on tozadenant Phase 3 program

2015 at 10.15 a.m.

Biotie provides update on tozadenant Phase 3 program

Biotie has further refined its plans for the design and conduct of Phase 3
trials in Parkinson's disease (PD) patients experiencing levodopa related
end-of-dose 'wearing-off' (motor fluctuations). The phase 3 program will
consist of a double- blind trial with an open-label extension and, providing
this demonstrates safety and efficacy, will be followed by a separate
open-label trial to generate further clinical safety data.

The refinement in the trial design does not impact the expected overall
timeline to submission of a U.S. New Drug Application for tozadenant, but
allows top-line results from the double-blind portion to be available by the
end of 2017, approximately one year earlier than previously planned, while
maintaining adequate statistical power in the study.

In the double-blind portion, 450 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 time spent in the "off" state in patients taking tozadenant as compared to
placebo between baseline and week 24. Secondary endpoints will include "on"
time without troublesome dyskinesia, the Unified Parkinson's Disease Rating
Scale, Clinical Global Impression of Change and Patient Global Impression of
Change. The placebo-controlled period will be followed by a 52 week open
label treatment period to collect additional clinical safety data. The study
is expected to start recruiting patients in the United States, Canada and
selected European countries in the middle of 2015. Based on current estimates
and the number of patients being enrolled into the study, top-line data is
expected to be available by the end of 2017.

Providing the double-blind portion of the trial meets its primary efficacy
endpoint, another open-label trial will be initiated in a separate population
of 450 PD patients to establish the requisite number of unique patient
exposures required for approval. The open label trial will evaluate safety
over a year and is also expected to be conducted in North America and
selected European countries. Patients will be dosed with 120 mg of tozadenant
twice/day, although the investigator may adjust the dose to 60 mg twice/day
based on individual response.

Turku, 23 April 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:


NASDAQ OMX Helsinki Ltd
Main media

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 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.

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.


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Biotie Therapies Oyj via Globenewswire


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