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Biotie: nepicastat study in cocaine dependence completes enrollment ahead of schedule - top-line data expected around end 2014


Biotie: nepicastat study in cocaine dependence completes enrollment ahead of
schedule - top-line data expected around end 2014

Biotie Therapies today announced that patient enrollment into the Phase 2
study investigating nepicastat for cocaine dependence has been completed
ahead of schedule. The 11-week, 179-patient study is being conducted at 10 US
clinics under a Collaborative Research and Development Agreement (CRADA) with
the National Institute on Drug Abuse (NIDA) at the US National Institutes of
Health. Top-line results from the study are expected around the end of 2014.

"The extraordinary commitment that both NIDA and the trial investigators have
shown for this program has helped the study exceed the already ambitious
enrollment targets", commented Dr. Stephen Bandak, CMO of Biotie. "We look
forward to completion of the clinical treatment phase and await the top-line
results, scheduled to be available around year end, with great interest."

Turku, 27 May 2014

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),stephen.bandak@biotie.com

Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900,virve.nurmi@biotie.com


NASDAQ OMX Helsinki Ltd
Main Media

About nepicastat (SYN117)

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

Nepicastat is currently in Phase 2 development for cocaine dependence. A
previously completed placebo-controlled Phase 2a study in non-treatment
seeking cocaine addicts showed that nepicastat had a favourable safety
profile and was well tolerated when administered with cocaine. An 11-week
Phase 2 safety and efficacy trial in 179 treatment seeking cocaine addicted
patients, funded by the U.S. National Institute on Drug Abuse under a
Collaborative Research and Development Agreement, has completed patient
enrollment, and top-line results are expected around the end of 2014.

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

About Biotie

Biotie is a specialized drug development company focused on products for
neurodegenerative and psychiatric disorders. For the past years, Biotie has
successfully operated a strategy built around search, profile and partner.
This has delivered Selincro (nalmefene) for alcohol dependence, which
received European marketing authorization in February 2013 and is currently
being rolled out across Europe by partner H. Lundbeck A/S, and tozadenant, a
novel A2a antagonist which is transitioning into Phase 3 development for
Parkinson's disease and for which Biotie holds exclusive, global rights.
Biotie is actively developing its pipeline assets, including SYN120, a unique
potent 5-HT6/5-HT2a dual antagonist for which Biotie expects to conduct a
Phase 2 study in Alzheimer's disease; nepicastat, a selective inhibitor of
dopamine beta hydroxylase which is currently in a Phase 2 study, fully funded
by NIDA, for treatment seeking cocaine addicts; and BTT-1023, a monoclonal
antibody targeting Vascular Adhesion Protein 1 for which Biotie intends to
conduct a Phase 2 study in primary sclerosing cholangitis, a rare fibrotic
disease of the liver. Biotie's shares are listed on NASDAQ OMX Helsinki.


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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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