Biotie Therapies Oyj : Biotie announces start of clinical study with nepicastat (SYN117) in cocaine dependence

     Biotie Therapies Oyj : Biotie announces start of clinical study with
                  nepicastat (SYN117) in cocaine dependence


Biotie announces start of clinical study with nepicastat (SYN117) in cocaine

Biotie Therapies today announced the start of a Phase 2 clinical study
evaluating nepicastat (SYN117) in cocaine dependence. The National Institute
on Drug Abuse (NIDA) at the US National Institutes of Health is funding the
conduct of the study under a Collaborative Research and Development Agreement
(CRADA) signed in December 2011.

The study is a randomized, double-blind placebo-controlled 11-week trial and
is expected to enroll about 180 treatment-seeking cocaine-dependent subjects.
The study will be conducted at approximately 12 US clinics specializing in the
treatment of drug dependence.

The trial is expected to take approximately two years to complete.

Turku, 10 May 2013

Biotie Therapies Corp.

Timo Veromaa
President and CEO

For further information, please contact:
Dr. Stephen Bandak, Chief Medical Officer

tel. +1 650 296 0946 (Pacific Time zone), email:

Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900, e-mail:


NASDAQ OMX Helsinki Ltd
Main Media


Nepicastat is an orally administered, potent and selective inhibitor of the
enzyme dopamine beta-hydroxylase (DBH) which converts dopamine into
norepinephrine. Like many other addictions, cocaine dependence is driven by
dysregulation in the dopamine-reward system. Inhibition of DBH by nepicastat
increases levels of dopamine, which may reduce craving for cocaine, and
reduces the levels of norepinephrine, which may decrease the pleasurable
responses to cocaine and the potential for stress-induced relapse following
withdrawal. Biotie has previously conducted a placebo-controlled Phase 2a
study in non-treatment seeking cocaine addicts. The study showed that
nepicastat had a favourable safety profile and was well tolerated when
administered with cocaine.

Nepicastat has also been evaluated as a potential treatment for post-traumatic
stress disorder (PTSD). In December 2012, Biotie announced top-line data from
an investigator-initiated Phase 2 study in PTSD. In this study, nepicastat was
generally well tolerated but was not effective in relieving PTSD-associated
symptoms when compared to placebo. Biotie is evaluating data from this study
in further detail and will then decide on next steps with nepicastat in PTSD

Biotie holds full rights to nepicastat and will be able to use data from
studies conducted with NIDA to support future potential regulatory


Biotie is a specialized drug development company focused on the development of
drugs for neurodegenerative and psychiatric disorders (e.g. Parkinson's
disease, Alzheimer's disease and other cognitive disorders, alcohol and drug
dependence (addiction) and post-traumatic stress disorder), and inflammatory
and fibrotic liver disease. The company has a strong and balanced development
portfolio with several innovative small molecule and biological drug
candidates at different stages of clinical development. Biotie's products
address diseases with high unmet medical need and significant market

Biotie's most advanced product, Selincro (nalmefene), licensed to H. Lundbeck
A/S, has on 28 February 2013 received European marketing authorization for the
reduction of alcohol consumption in adult patients with alcohol dependence who
have a high level of alcohol consumption. In addition, Biotie has a strategic
collaboration with UCB Pharma S.A. covering tozadenant which is transitioning
into Phase 3 development for Parkinson's disease. Biotie shares are listed on
NASDAQ OMX Helsinki Ltd.


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The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other
applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of
information contained therein.

Source: Biotie Therapies Oyj via Thomson Reuters ONE
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