Biotie Therapies - Company Announcement

Biotie's partner Lundbeck submits European Marketing Authorization Application for Selincro(TM) (nalmefene)

BIOTIE THERAPIES CORP.    STOCK EXCHANGE RELEASE   21 December  2011 at 9.30
a.m.

Biotie's partner Lundbeck submits European Marketing Authorization Application
for Selincro(TM) (nalmefene)

Biotie Therapies announced today that its partner Lundbeck has submitted a
marketing authorization application (MAA) through the centralized procedure to
the European Medicines Agency (EMA) for Selincro(TM) (nalmefene), a novel opioid
receptor ligand intended for the treatment of alcohol dependence. The dossier
has been accepted for review by the EMA.

Timo Veromaa, Chief Executive Officer of Biotie said, "Filing of Selincro(TM) in
Europe is an important step in bringing this novel treatment to patients.
Existing drugs for alcohol dependence require abstinence, which is a very high
treatment hurdle. Selincro(TM) provides a solution for patients by allowing them
to take the drug on an as needed basis, leading to a reduction in their alcohol
consumption and number of heavy drinking days."

Lundbeck plans to present efficacy and safety data from its Phase 3 program at
the 20th European Congress of Psychiatry (EPA) in Prague, Czech Republic, 3-6
March 2012.

In Turku, 21 December 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

Media contact:
Pete Chan, Tudor Reilly
Mobile +44 (0) 7725 554 632.
Office: +44 (0) 20 7034 7608

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About the Phase 3 program

Based on the results of previous trials sponsored by Biotie, Lundbeck initiated
three Phase 3 clinical studies in Europe in 2008 enrolling a total of
approximately 2,000 individuals with alcohol dependence who were randomized into
two groups receiving Selincro(TM) (18 mg tablet as needed, orally) or placebo,
in addition to a brief medical compliance program focused on motivation and
adherence. Two of the three trials (ESENSE1 and ESENSE2), in which individuals
were treated over a period of six months, were primarily aimed to demonstrate
the efficacy of nalmefene, whilst the third study (SENSE), in which individuals
were treated for 12 months, was primarily conducted to confirm the safety and
tolerability of the compound.

Lundbeck assessed a wide range of primary and secondary endpoints in its Phase
3 program for nalmefene including: number of heavy drinking days per month,
total alcohol consumption, proportion of responders based on drinking measures,
alcohol dependence symptoms and clinical status, liver function and other
laboratory tests, pharmaco-economic outcomes and treatment discontinuation
effects. All assessments were consistently in favour of nalmefene compared to
placebo, and overall, nalmefene reduced heavy drinking days and total alcohol
consumption by more than 50% compared to pre-treatment baseline. The effect was
observed already during the first month of treatment and was maintained
throughout the study period in the three trials.

Furthermore, data from the 12-month safety study (SENSE) confirmed that the
treatment effect of nalmefene was maintained and even improved after 1 year of
treatment. Approximately two-thirds of the individuals in the studies had
previously not been treated for alcohol dependence, despite an ongoing
affliction, indicating that reduction of alcohol intake represents an attractive
treatment objective compared to current treatments which all require abstinence.

The safety profile of nalmefene was consistent with observations and data
provided in earlier studies, including Biotie's previously completed Phase 3
program. The most frequent adverse events in patients taking nalmefene were
dizziness, insomnia and nausea. These adverse events were usually mild and
transient in nature. The three studies in the Lundbeck Phase 3 clinical program
were conducted in Europe and enrolled about 2,000 individuals with alcohol
dependence. Including prior studies conducted by Biotie, the total clinical
database now contains more than 3,000 patients with alcohol dependence.

About Selincro(TM) (nalmefene)

Selincro(TM) (nalmefene) is a small molecule distinct opioid system modulator
that inhibits the reward pathway in the brain that reinforces the desire and
craving for alcohol and other addictive substances. As a result, Selincro(TM)
removes a person's desire to continue 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 Selincro(TM) and on the product reaching certain
predetermined sales. Lundbeck will be responsible for manufacturing and
registration of the product.

About alcohol dependence

Alcohol dependence 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.
Alcohol dependence also has potentially fatal consequences such as liver
cirrhosis and cancer, among others. As a result, this disease is one of the most
serious health concerns in the western world, both socially and economically,
with estimated associated costs to society of at least EUR 200 billion per
annum. It is estimated that in any given year approximately 3.4% of EU citizens
over 15 years of age suffer from alcohol dependence, corresponding to more than
14 million people. Despite this, alcohol dependence 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 dependence require
abstinence from drinking as a starting point - a high hurdle for an alcohol
dependent patient. There are only a few pharmaceutical compounds that have
received marketing approval to help alcohol dependent patients maintain
abstinence. All these treatments, including psychosocial counseling measures,
cannot prevent patients from relapsing and the long term prognosis remains poor.
There are no approved therapies on the market yet to proactively help curb a
person's urge to drink.

About Biotie

Biotie is an international biopharmaceutical company focused on the development
of innovative, clinically differentiated medicines to address unmet medical
needs primarily associated with neurological and psychiatric diseases and
selected inflammatory diseases. Biotie aims to develop treatment solutions that
will improve the lives of patients with conditions such as Parkinson's and
Alzheimer's diseases, drug dependence and inflammatory liver disease.

Biotie's highly experienced development teams in Europe and the US are focused
on efficiently delivering safety and efficacy data for the company's compounds.
For niche indications, Biotie will consider bringing products to market by
itself. For larger indications, it will seek strategic partnerships with
pharmaceutical partners for late-stage development and commercialization.
Current pharmaceutical partners include Lundbeck, Roche, UCB Pharma, and
Seikagaku.

Biotie's most advanced product is nalmefene (Selincro(TM)) for alcohol
dependence. Selincro(TM) has completed Phase 3 clinical development and a
marketing authorization application has been submitted for review to the
European Medicines Agency by licensing partner Lundbeck.




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