Biotie Therapies - Company Announcement

Biotie Announces Positive Results from First Two Phase III Studies with Nalmefene in Alcohol Dependence

BIOTIE THERAPIES CORP.   STOCK EXCHANGE RELEASE 3 January 2011 at 9.00 a.m.


Biotie Announces Positive Results from First Two Phase III Studies with
Nalmefene in Alcohol Dependence

  * According to headine results from ESENSE1 and SENSE, nalmefene is safe and
    efficacious in helping individuals to reduce their alcohol consumption

  * ESENSE2, a second 24-week efficacy study, is expected to conclude in
    2Q 2011

  * Lundbeck is on track to submit an MAA in Europe in 2H 2011, pending the
    successful completion of ESENSE2

Biotie's partner, H. Lundbeck A/S (Lundbeck), has today announced that it has
completed two Phase III clinical trials evaluating nalmefene for the treatment
of alcohol dependence (ESENSE1, SENSE). Lundbeck expects to complete a further
efficacy study (ESENSE2) in 2Q 2011 and plans to file a marketing authorisation
application (MAA) in Europe in 2H 2011, depending on the outcome of the final
study. Lundbeck plans to submit detailed efficacy and safety data for
presentation at scientific and medical meetings after all three trials have been
completed.

Timo Veromaa, Chief Executive Officer of Biotie stated: "We are delighted with
the continued favourable profile of nalmefene and look forward to the results
from ESENSE2 later this year. We believe that nalmefene could significantly
transform the treatment of alcohol dependence by providing patients with a real
alternative to current abstinence-based therapies. Helping patients to reduce
harmful levels of alcohol consumption is an important clinical goal and we
believe the unique "as needed" approach with nalmefene - which aims to put the
patient back in control of their disease - could create a real paradigm shift in
the management of alcohol dependence. We are excited to be working with our
partner Lundbeck, a global leader in CNS drug development, to bring this
important product to market."

ESENSE1, a 24-week efficacy study, and SENSE, a 52-week safety study, were
designed to investigate efficacy and safety of 20mg nalmefene taken "as needed"
versus placebo in patients with alcohol dependence. In both studies, which
enrolled around 1,300 patients in total, psychosocial intervention consisted of
a brief, standardised programme focussed on adherence and follow-up. No
abstinence treatment goals were imposed. The data from these studies is
consistent with the profile of nalmefene observed in previous clinical studies.
The most frequent adverse events included dizziness, insomnia and nausea.

Lundbeck has indicated it will initiate a dialogue with the healthcare agencies,
as well as scientific advisors, to discuss the outcomes from these clinical
trials and its plans for submitting a European Marketing Authorization
Application (MAA) for nalmefene as a treatment for alcohol dependence. "We
expect Lundbeck to assess the full data package, including results from the
final Phase III trial (ESENSE2), before filing nalmefene in Europe", commented
Dr. Veromaa.

Biotie has previously conducted three Phase II studies and two Phase III studies
in alcohol dependence. The largest of the previous Phase III trials, conducted
in 400 patients with alcohol dependence, demonstrated that nalmefene, taken "as
needed", significantly reduced the average alcohol intake per patient and the
number of heavy drinking days (classed as intake above five standard drinks of
alcohol). Previous trials have also shown nalmefene to be well-tolerated and
safe. Biotie's patient dossier for nalmefene includes approximately 1,100
patients and will expand to approximately 3,000 patients when all three Phase
III studies being conducted by Lundbeck have been completed.

Nalmefene builds on a novel principle of treating alcohol dependence. Unlike
existing therapies, treatment with nalmefene is not aimed at keeping the
patients from drinking. Instead, nalmefene helps to control and limit the intake
of alcohol. Reduction of alcohol consumption to less harmful levels is supported
by specialists as a valuable treatment option to increase willingness among
patients to initiate treatment and to keep the patients in treatment. In
addition, nalmefene distinguishes itself by being available as a tablet
formulation to be taken only according to need, ("as needed"), whereas existing
pharmaceuticals must be taken continuously over a longer period of time and are
aimed at maintaining abstinence.

About the Phase III programme

Based on the results of earlier Biotie-sponsored trials, Lundbeck is conducting
an extensive Phase III clinical trial programme for nalmefene in Europe,
including two 24-week efficacy studies (ESENSE1, ESENSE2) and a 52-week long-
term safety study (SENSE), enrolling in total around 2,000 patients. Patients
are randomised to receive nalmefene (20 mg as needed, orally) or placebo.
ESENSE1 and ESENSE2 are primarily aimed to demonstrate the efficacy of
nalmefene, whilst the primary objective of SENSE, is to confirm the safety and
tolerability of nalmefene, as well as to investigate the benefit of treatment
over a prolonged period of time.

About nalmefene

Nalmefene is a small molecule opioid receptor antagonist that inhibits  the
reward pathway in the brain that reinforces the desire and craving  for alcohol
and other addictive substances. As a result, nalmefene removes a person's desire
to drink. Biotie has licensed global rights to nalmefene to Lundbeck. Under the
terms of the agreement, Biotie is eligible for up to EUR 84 million in upfront
and milestone payments plus royalties on sales from Lundbeck. Biotie has already
received EUR 12 million from Lundbeck. Further milestone payments are expected
on commercial launch of nalmefene and on the product reaching certain
predetermined sales. Lundbeck will be responsible for manufacturing and
registration of the product.

About alcohol dependence

Alcohol dependence, otherwise commonly known as alcoholism, is a  disease in
which the afflicted person continually craves alcohol, is  unable to limit his
or her drinking, needs to drink greater amounts to  get the same effect and has
withdrawal symptoms after stopping alcohol use. While close to 270 million
adults are estimated to drink alcohol up to 20g (women) or 40g (men) per day,
over 58 million adults (15%) consume above this level, with 20 million of these
(6%) drinking the equivalent of 5 - 6 standard drinks every day. Looking at
addiction rather than drinking levels, it is estimated that 23 million Europeans
(5% of men, 1% of women) are dependent on alcohol in any one year[1].

Alcohol is the third leading cause of ill health after tobacco smoking and
hypertension; there are more risks associated with alcohol than with elevated
cholesterol levels and obesity. Excessive consumption of alcohol, which
increases the risk of developing a number of diseases such as cancer,
cardiovascular diseases, cerebral atrophy, ulcer and cirrhosis of the liver, is
a common problem in many parts of the world. One in ten deaths in the Western
world is alcohol-related. Despite this, alcoholism tends to be severely  under-
diagnosed with only approximately 13% of alcohol dependants receiving treatment,
characterizing it as a large unmet medical need.

Currently,  conventional methods of treating alcohol addiction require
abstinence  from drinking as a starting point - a high hurdle for an alcohol
dependence patient. There are only a few pharmaceutical compounds that  have
received marketing approval to help alcoholics maintain abstinence.  All these
treatments, including psychosocial counseling measures,  cannot prevent a high
relapse rate of the patients and permanent cure is  thus still the exception
rather than the rule.

There are no approved therapies on the market yet to proactively help curb a
person's urge to drink.

Turku, 3 January 2011

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 Biotie Therapies

Biotie is a specialized drug development company focused on central nervous
system and inflammatory diseases. It has 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
potential, including addiction and a broad range of inflammatory conditions such
as rheumatoid arthritis or 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.

Biotie is based in Turku, Finland and its shares are listed on NASDAQ OMX
Helsinki Ltd.

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


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[1] Alcohol in Europe - A public health perspective; A report for the European
Commission; June 2006


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