BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 30 July 2014
at 8.50 a.m.
Biotie updates outlook on tozadenant and SYN120
* Tozadenant to advance into Phase 3 in Parkinson's disease within Biotie's
proprietary portfolio
* SYN120 to advance into Phase 2 in Parkinson's disease dementia, further
strengthening Biotie's presence in Parkinson's disease space
Biotie has decided to advance tozadenant, its adenosine A2a receptor antagonist
for Parkinson's disease, into Phase 3 development as part of the Company's
proprietary portfolio. Preparations for Phase 3 development are ongoing, and it
is expected that the Phase 3 clinical studies can commence recruitment in H1
2015, as originally planned.
Following the decision by UCB Pharma S.A. to return global rights to tozadenant
in March 2014, Biotie has been evaluating the most suitable development strategy
for this Phase 3 ready asset to maximize its value to shareholders and has
concluded that this can be best achieved by continuing with the Phase 3 study
within its current portfolio. The Company considers tozadenant to potentially be
its most valuable asset given the high unmet medical need in Parkinson's disease
and stage of development and is currently evaluating various options, which may
include a capital increase, to support the clinical studies and a strong
regulatory filing package for tozadenant.
As announced in July 2014, Biotie has received a USD 2.0 million (EUR 1.5
million) grant from The Michael J. Fox Foundation (MJFF) for a Phase 2 study in
Parkinson's disease dementia. The study is currently expected to begin
recruitment around the end of 2014. As a result of this grant and the decision
on tozadenant, the previously planned Phase 2 study in Alzheimer's disease will
not begin recruitment by the end of 2014 and will be assessed based on the
development status of the other products within Biotie's portfolio.
Biotie's interim report for January 1 - June 30, 2014 will be published on
Wednesday July 30, 2014.
Turku, 30 July 2014
Biotie Therapies Corp.
Timo Veromaa
President and CEO
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
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. Biotie holds global rights to
tozadenant.
Preparations for the tozadenant Phase 3 program in Parkinson's disease are
progressing well, and patient recruitment is expected to begin in H1 2015.
About SYN120
SYN120 is an oral, potent, dual antagonist of the 5-HT6 and 5-HT2a receptors.
These two distinct properties could result in a unique therapeutic profile for
SYN120 combining pro-cognitive and antipsychotic activities. SYN120 has
completed single and multiple ascending dose Phase 1 clinical studies and a
Phase 1 positron emission tomography imaging study to determine therapeutic dose
for subsequent Phase 2 studies. SYN120 is currently advancing into Phase 2
development, and the first study will be assessing its safety and efficacy in
Parkinson's disease dementia. Biotie holds global rights to SYN120.
The Phase 2 study in Parkinson's disease dementia is funded by the Michael J.
Fox Foundation. Preparations for the study are underway, and patient recruitment
is expected to begin around the end of 2014.
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 three additional
compounds which are in Phase 2 development for cognitive disorders including
Parkinson's disease dementia, cocaine dependence, and primary sclerosing
cholangitis (PSC), a rare fibrotic disease of the liver.
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