2010-09-14 08:30:00 CEST

2010-09-14 08:32:26 CEST


REGULATED INFORMATION

English
Biotie Therapies - Company Announcement

Biotie completes Phase I with VAP-1 antibody - BTT-1023 continues to demonstrate favourable safety profile


BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 14 September 2010 at 9:30 a.m.

Biotie completes Phase I with VAP-1 antibody - BTT-1023 continues to demonstrate
favourable safety profile

Biotie today reported top-line data from a recently completed Phase I study with
its fully human VAP-1 monoclonal antibody (BTT-1023) in patients with plaque
psoriasis.

The study evaluated the safety, tolerability, and pharmacokinetics of repeated
doses of intravenously administered antibody in 26 patients with active plaque
psoriasis. The antibody, administered at repeated doses of up to 8 mg/kg, was
generally well tolerated, and the pharmacokinetic characteristics of BTT-1023 in
psoriasis patients were consistent with those observed in a previously completed
study in rheumatoid arthritis (RA) patients. The study was not designed to
enable formal statistical evaluation of therapeutic activity. However, whereas
no change in disease activity was noted during the treatment period in any
patient receiving placebo, several patients on active drug experienced an
improvement in their condition, reflected as decreases in their Psoriasis Area
Severity Index (PASI) scores and physicians' clinical assessments. No PASI50
responses (50% decrease in PASI score) were observed within the relatively short
treatment period. Two patients on active drug were reported to have experienced
a transient exacerbation of their psoriasis symptoms that occurred after the
treatment had been completed; apart from these two cases, no serious or severe
adverse events were reported in the study subjects."We are very encouraged by the continued good tolerability and pharmacokinetic
profile of BTT-1023", said Timo Veromaa, President and CEO of Biotie Therapies
Corp. "The favorable safety data combined with the signals of therapeutic
activity that we saw particularly in our rheumatoid arthritis study form, in our
opinion, a solid Phase I package for BTT-1023. In addition, our recent
non-clinical activities have uncovered interesting therapeutic potential for
BTT-1023 beyond RA; this provides us with several attractive opportunities for
BTT-1023 in inflammatory conditions, including respiratory disease. We will
evaluate these data in detail to determine the best way forward and, at the same
time, will continue our ongoing discussions with potential license partners."

Turku, 14 September 2010

Biotie Therapies Corp.

Timo Veromaa
President and CEO

For further information, please contact:

Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8911, e-mail:virve.nurmi@biotie.com

www.biotie.com

Distribution:

NASDAQ OMX Helsinki Ltd
Main Media

ABOUT STUDY BTT12-CD016

Study BTT12-CD016, conducted within the EU, was a randomized,
placebo-controlled, double-blind multiple ascending dose study. After an
open-label single-dose pilot phase involving 2 patients, the double-blind part
of the study was conducted in 4 sequential cohorts of 6 patients. Within each
cohort, 5 patients were randomized to receive active drug and 1 patient to
receive placebo under double-blind conditions. The BTT-1023 doses in the
sequential cohorts were 1, 2, 4 and 8 mg/kg. In this 3 month study, 3 doses of
study drug were administered intravenously on study days 1, 8 and 22, with
post-treatment follow-up continuing for 9 weeks after the last dose.

The study subjects were required to have active plaque psoriasis, with their
Psoriasis Area Severity Index (PASI) scores and affected body surface areas
(BSA%) within predefined ranges. Safety and tolerability were assessed with
adverse event inquiries and comprehensive laboratory analyses, while treatment
response was assessed with a number of subjective and objective assessments that
are widely used in psoriasis trials.

ABOUT BTT-1023 AND VAP-1

BTT-1023 is a fully human monoclonal antibody based on Medarex, Inc.'s HuMab
technology. The antibody targets Vascular Adhesion Protein 1 (VAP-1), an
endothelial adhesion molecule. Inhibiting VAP-1 reduces inflammation by
regulating the migration of leukocytes, or white blood cells, to inflamed
tissues. Pathological accumulation of white blood cells in tissue is a common
feature in many autoimmune diseases, such as rheumatoid arthritis, ulcerative
colitis, and psoriasis.

Biotie has licensed the rights to develop and commercialize BTT-1023 in Japan,
Taiwan, Singapore, New Zealand and Australia to Seikagaku Corporation. Biotie
retains ownership in the rest of the world and is looking for additional
collaboration opportunities.

ABOUT BIOTIE THERAPIES

Biotie is a drug discovery and development company focused on central nervous
system and inflammatory diseases. It has a broad range of innovative small
molecule and biological drug candidates at different stages of clinical and
pre-clinical development. Biotie's products address diseases with high unmet
medical need and significant market potential, including addiction and psychotic
disorders, rheumatoid arthritis, psoriasis and chronic obstructive pulmonary
disease (COPD). The most advanced product, nalmefene for alcohol dependence, is
currently in phase III clinical development by licensing partner H. Lundbeck
A/S.

The commercial value of the pipeline has been demonstrated through existing
alliances with top-tier global pharmaceutical companies such as Lundbeck, Roche
and Pfizer. Biotie has operations in Turku, Finland and Radebeul, Germany.

Biotie shares are listed on NASDAQ OMX Helsinki Ltd.

For more information, please refer to www.biotie.com



[HUG#1444238]