2010-04-26 12:00:00 CEST

2010-04-26 12:01:10 CEST


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Biotie Therapies - Company Announcement

Biotie reports positive top-line data from clinical study with its third generation oral PDE4 inhibitor - ELB353 is well tolerated and shows clear pharmacological activity


BIOTIE THERAPIES CORP.    STOCK EXCHANGE RELEASE   26 April 2010   at 1.00 p.m.

Biotie reports positive top-line data from clinical study with its third
generation oral PDE4 inhibitor - ELB353 is well tolerated and shows clear
pharmacological activity

Biotie today reported that it has successfully completed a Phase I trial with
its orally administered phosphodiesterase 4 (PDE4) inhibitor ELB353, intended
for the treatment of chronic obstructive pulmonary disease (COPD).

The study evaluated the safety, tolerability, pharmacokinetic characteristics
and pharmacodynamic effects of repeated oral doses of ELB353 in 48 healthy male
volunteers. ELB353 was generally well tolerated, and no serious or severe
adverse events were reported in any of the study subjects. The pharmacokinetic
characteristics of ELB353 demonstrated its suitability for a once daily dosing
regimen. Robust and statistically highly significant biomarker responses
confirmed the pharmacological activity of well tolerated doses of ELB353 in man."We are very pleased with the properties of ELB353 seen in this study", said
Timo Veromaa, President and CEO of Biotie Therapies Corp. "These data, combined
with the recommendation for approval of the first PDE4 inhibitor in the EU last
week, confirm our commitment to move forward with a Phase II program in COPD
patients and may also provide an interesting entry point for a partner into the
development program."

Turku, April 26, 2010

Biotie Therapies Corp.

Timo Veromaa
President and CEO

For further information, please contact:

Dr. Antero Kallio, Chief Medical Officer
tel. +358 2 274 8900, e-mail:antero.kallio@biotie.com<mailto:virve.nurmi@biotie.com>

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

Distribution:
NASDAQ OMX Helsinki Ltd
Main Media

About Study BTT70-CD018

Study BTT70-CD018, conducted within the EU, was a randomized,
placebo-controlled, double-blind multiple ascending dose study conducted in 6
sequential cohorts of 8 healthy male volunteers. Within each cohort, 6 patients
were randomized to receive active drug and 2 patients to receive placebo under
double-blind conditions. Study drugs were administered orally for 10 days, and
the highest studied dose of ELB353 was 100 mg/day.

Safety and tolerability were evaluated with clinical assessments, adverse event
inquiries, comprehensive laboratory analyses and Holter ECGs. Pharmacological
activity was determined with a biomarker assay. This assay, which is performed
with whole blood samples collected from the study subjects, measured the ability
of ELB353 to inhibit lipopolysaccharide (LPS) -induced tumor necrosis factor
alpha (TNFa) release from blood cells. Inhibition of LPS-induced TNFa release ex
vivo is considered a clinically relevant and reliable biomarker of PDE4
inhibition.

As expected in an ascending dose design, the highest studied dose levels were
associated with mild to moderate adverse events in some study subjects, but a
maximum tolerated dose (MTD) was not reached. In the biomarker assay, TNFa
release was decreased by up to 45% from baseline with well tolerated doses of
ELB353, whereas no decrease from baseline occurred with placebo.

About ELB353

ELB353 stems from Biotie's proprietary PDE technology platform. It is a third
generation orally administered PDE4 inhibitor with therapeutic potential in
chronic inflammatory disorders, particularly in COPD, a serious respiratory
disorder with major unmet medical need. In preclinical models, ELB353
demonstrated a broader therapeutic window than other PDE-4 inhibitors and was
free of central nervous system related side effects at therapeutically relevant
doses. This is likely due to hepatic conversion of ELB353 to a major active
metabolite which exhibits low brain penetration.

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/>



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