Biotie Therapies - Company Announcement

Biotie: Selincro(TM) (nalmefene) receives positive opinion for approval in the European Union

BIOTIE THERAPIES CORP.     STOCK EXCHANGE RELEASE     14 December 2012 at 14:10

Selincro(TM) (nalmefene) receives positive opinion for approval in the European
Union

Biotie today announced that its partner H.Lundbeck A/S (Lundbeck) has received a
positive opinion from the Committee for Medicinal Products for Human Use (CHMP)
of the European Medicines Agency (EMA) recommending marketing authorization of
Selincro(TM) (nalmefene; an opioid system modulator) for the reduction of
alcohol consumption in adult patients with alcohol dependence who have a high
level of alcohol consumption.  Once approved, Lundbeck will provide Selincro as
part of a new treatment concept that includes continuous psychosocial support
focused on the reduction of alcohol consumption and treatment adherence.

The European Commission usually delivers its final decision on approval within
2-3 months of the CHMP recommendation. The decision will be applicable to all
27 European Union member states plus Iceland and Norway. Subject to the
Commission's final approval and completion of pricing and reimbursement
discussions, Lundbeck expects to launch Selincro in a number of European markets
by mid-2013."This is a historic occasion for Biotie. We are extremely pleased that the CHMP
has recommended Selincro for approval and we look forward to the final decision
from the European Commission in the coming months." said Timo Veromaa, President& CEO of Biotie. He continued, "There are limited options available for patients
who need to reduce their harmful levels of alcohol intake and, for many,
stopping drinking is not an acceptable or achievable treatment goal. Selincro
will be the first product specifically developed to reduce alcohol consumption
without the need to completely abstain from drinking.  In Europe alone, over
10% of all deaths in adults are attributable to alcohol - this represents a huge
medical burden and one we hope Selincro will help to address by providing
physicians and patients with a fresh approach to treatment".

The CHMP opinion was based on the results from three pivotal, randomized,
double-blind, placebo controlled clinical trials studying the effects of 18 mg
Selincro in adult patients with alcohol dependence.  These studies included
approximately 2,000 patients diagnosed with alcohol dependence; two-thirds of
these patients had never before received treatment for their disease.

Turku, 14 December 2012

Biotie Therapies Corp.

Timo Veromaa
President and CEO

For further information, please contact:

Timo Veromaa President and CEO
tel. +358 2274 8900, email: timo.veromaa@biotie.com

Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900, e-mail: virve.nurmi@biotie.com

www.biotie.com

Distribution:
NASDAQ OMX Helsinki Ltd

Main Media

ABOUT THE CLINICAL STUDIES:

For the approval of Selincro, efficacy was assessed in patients with a high
drinking risk level (defined by WHO: men > 60 gram per day, women >40 gram per
day (1 standard drink ~ 10 grams of alcohol)). Patients enrolled in the studies
with high drinking risk level drank on average 10.5 standard drinks per day
(equivalent to approximately 1.5 bottles of wine). Patients treated with
Selincro showed a more than 40% reduction in total alcohol consumption within
the first month, and at study end (6 or 12 months) the alcohol intake was
reduced by more than 60%. This corresponds to an average reduction equal to
nearly one bottle of wine per day. The reduction of alcohol consumption in
patients with high drinking risk level was significantly better than placebo at
study end in all three studies and considered clinically relevant. Data from the
1-year study suggested longer term efficacy of Selincro beyond 6 months and up
to 1 year of treatment. There were no major safety concerns identified during
the studies, and Selincro was generally well tolerated.

ABOUT SELINCRO (nalmefene):

Once approved, Selincro will be indicated for the reduction of alcohol
consumption in adult patients with alcohol dependence who have a high drinking
risk level (>60 g/day for men, >40 g/day for women) without physical withdrawal
symptoms and who do not require immediate detoxification.  Selincro should be
prescribed in conjunction with continuous psychosocial support focused on
treatment adherence and the reduction of alcohol consumption. Treatment should
be initiated only in patients who continue to have a high drinking risk level
two weeks after an initial assessment.  Selincro is to be taken as-needed; that
is, on each day the patient perceives a risk of drinking alcohol, one tablet
should be taken, preferably 1-2 hours prior to the anticipated time of drinking.

Biotie has licensed global rights to Selincroto Lundbeck. Under the terms of the
agreement,  Biotie is eligible for up to EUR 89 million in upfront and milestone
payments plus royalties on sales of Selincro. Biotie has previously received EUR
12 million of such milestone payments from Lundbeck. Further milestone payments
are expected on potential commercial launch of nalmefene and on the product
potentially reaching certain predetermined sales. Lundbeck is responsible for
the registration, manufacturing and marketing of the product.

ABOUT ALCOHOL DEPENDENCE:

Alcohol dependence is a brain disease with a high probability of following a
progressive course(1,2). Alcohol is toxic to most organs of the body, and the
level of consumption is strongly correlated with the risk for long-term
morbidity and mortality(3). Alcohol is a causal factor in more than 60 types of
disease and injury(4). Genetic and environmental factors are important in the
development of alcohol dependence; genetic factors account for an estimated 60%
of the risk of developing the disease(5). A central characteristic of alcohol
dependence is the often overpowering desire to consume alcohol. Patients
experience difficulties in controlling the consumption of alcohol and continue
consuming alcohol despite harmful consequence(6).

Excessive alcohol consumption is common in many parts of the world, especially
in Europe where more than 14 million people are alcohol dependent(3,7). In
Europe the treatment gap is very large, with only 8% of patients receiving any
treatment.(8) Both abstinence and reduction goals should be considered as part
of a comprehensive treatment approach for patients with alcohol dependence(9).

ABOUT BIOTIE

Biotie is a specialized drug development company focused on the development of
drugs for neurodegenerative and psychiatric disorders (e.g. Parkinson's disease,
Alzheimer's disease and other cognitive disorders, alcohol and drug dependence
(addiction) and post-traumatic stress disorder), and inflammatory and fibrotic
liver disease. The company has a strong and balanced development portfolio with
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.

Biotie's most advanced product, SelincroTM (nalmefene), licensed to Lundbeck
A/S,  has on 14 December 2012 received a positive opinion from the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)
recommending marketing authorization of Selincro(TM) for the reduction of
alcohol consumption in adult patients with alcohol dependence who have a high
level of alcohol consumption. In addition, Biotie has a strategic collaboration
with UCB Pharma S.A. covering tozadenant which has successfully completed a
Phase 2b study in 420 patients with advanced Parkinson's disease. Biotie shares
are listed on NASDAQ OMX Helsinki Ltd.

References:

(1)Burge et al. Am Fam Physician 1999; 59(2): 361-370
(2)Leshner. Science 1997; 278: 45-47
(3)Rehm et al. Eur Addict Res 2003; 9: 147-156
(4)WHO. Global status report on alcohol and health, 2011
(5)Schuckit. Ch. 98. In: Davis et al (eds). Neuropsychopharmacology: The Fifth
Generation of Progress. 2002
(6)WHO, ICD-10, F10-19
(7)Wittchen et al. Eur Neuropsychopharmacol 2011;21(9): 655-679
(8)Kohn et al. Bull World Health Organ 2004; 82(11):858-866
(9)Ambrogne. J Subst Abuse Treat 2002; 22(1): 45-53




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