2010-01-19 08:00:00 CET

2010-01-19 08:02:23 CET


REGULATED INFORMATION

English
Biotie Therapies - Company Announcement

Biotie reports positive top-line data from clinical study with VAP-1 antibody in rheumatoid arthritis patients - BTT-1023 is well tolerated and shows signals of therapeutic activity


BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 19 January 2010 at 9.00 a.m.


Biotie reports positive top-line data from clinical study with VAP-1 antibody in
rheumatoid arthritis patients - BTT-1023 is well tolerated and shows signals of
therapeutic activity

Biotie today reported that it has successfully completed a clinical trial with
its fully human VAP-1 monoclonal antibody (BTT-1023) in rheumatoid arthritis
patients.

The study evaluated the safety, tolerability, and pharmacokinetics of repeated
doses of intravenously administered antibody in 24 rheumatoid arthritis patients
with an inadequate treatment response to methotrexate. The antibody,
administered at repeated doses of up to 8 mg/kg in combination with
methotrexate, was generally well tolerated, and no serious or severe adverse
events were reported in the study subjects. The pharmacokinetic characteristics
of BTT-1023 are consistent with those expected for an intravenously administered
monoclonal antibody intended for chronic conditions.

The study was not designed to enable formal statistical evaluation of
therapeutic activity. However, in several assessments of treatment effect such
as Disease Activity Score based on 28 joint assessment (DAS28) criteria,
American College of Rheumatology (ACR) criteria, physician's global assessment
and erythrocyte sedimentation rate, responses in higher dose groups were greater
than in the placebo group. Several patients receiving higher doses of BTT-1023
reached an ACR50 response (i.e. a 50% reduction in their ACR score) during
treatment."We are very pleased with the good tolerability and pharmacokinetic profile that
we saw with BTT-1023 in this study", said Timo Veromaa, President and CEO of
Biotie Therapies Corp. "These data, combined with signals of therapeutic
activity, provide, in our opinion, a good basis for proceeding into larger
therapeutic trials with BTT-1023. We plan to analyze and discuss these data with
our partner, Roche, to establish the optimal way to continue the clinical
development program. We expect a decision from Roche, regarding its option right
to in-license BTT-1023 at this stage of development, during the first half of
2010."


Turku, January 19, 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<mailto:virve.nurmi@biotie.com>

www.biotie.com <http://www.biotie.com/>

Distribution:

Helsinki Stock Exchange
Main Media


ABOUT STUDY BTT12-CD015

Study BTT12-CD015, conducted within the EU, was a randomized,
placebo-controlled, double-blind multiple ascending dose study 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 4 month study, 5 doses of study drug were administered
intravenously at 2 week intervals, with post-treatment follow-up continuing for
9 weeks after the last dose.

The study subjects were required to have active rheumatoid arthritis with a
predefined level of breakthrough symptoms while on a stable background regimen
of methotrexate. 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 rheumatoid arthritis trials.

A similarly designed companion study in patients with psoriasis (BTT12-CD106) is
currently underway, with expected completion by the end of Q2/2010.


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 and Roche have signed an option agreement for the antibody program
targeting VAP-1. Under the terms of the agreement, Roche has an exclusive option
right to an exclusive, worldwide license agreement for Biotie's fully human
antibody targeting VAP-1, excluding Japan, Taiwan, Singapore, New Zealand, and
Australia where rights are licensed to Seikagaku Corporation. The initial option
right will end upon completion of Phase I. Roche may extend the option right to
later development points by paying additional fees. Biotie will retain all
rights to the program until a license is granted to Roche.


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 <http://www.biotie.com/>




[HUG#1374619]