Biotie: Selincro(TM) (nalmefene) Receives Positive Opinion for

Biotie: Selincro(TM) (nalmefene) Receives Positive Opinion for
Approval in the European Union 
TURKU, FINLAND -- (Marketwire) -- 12/14/12 --  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  
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, Selincro(TM) (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 
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 
 
 
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