TURKU, FINLAND--(Marketwire - January 03, 2011) -
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
efficacious in helping individuals to reduce their alcohol consumption
* ESENSE2, a second 24-week efficacy study, is expected to conclude in
* 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
completed two Phase III clinical trials evaluating nalmefene for the
of alcohol dependence (ESENSE1, SENSE). Lundbeck expects to complete a
efficacy study (ESENSE2) in 2Q 2011 and plans to file a marketing
application (MAA) in Europe in 2H 2011, depending on the outcome of the
study. Lundbeck plans to submit detailed efficacy and safety data for
presentation at scientific and medical meetings after all three trials have
Timo Veromaa, Chief Executive Officer of Biotie stated: "We are delighted
the continued favourable profile of nalmefene and look forward to the
from ESENSE2 later this year. We believe that nalmefene could significantly
transform the treatment of alcohol dependence by providing patients with a
alternative to current abstinence-based therapies. Helping patients to
harmful levels of alcohol consumption is an important clinical goal and we
believe the unique "as needed" approach with nalmefene - which aims to put
patient back in control of their disease - could create a real paradigm
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
versus placebo in patients with alcohol dependence. In both studies, which
enrolled around 1,300 patients in total, psychosocial intervention
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
The most frequent adverse events included dizziness, insomnia and nausea.
Lundbeck has indicated it will initiate a dialogue with the healthcare
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",
Biotie has previously conducted three Phase II studies and two Phase III
in alcohol dependence. The largest of the previous Phase III trials,
in 400 patients with alcohol dependence, demonstrated that nalmefene, taken
needed", significantly reduced the average alcohol intake per patient and
number of heavy drinking days (classed as intake above five standard drinks
alcohol). Previous trials have also shown nalmefene to be well-tolerated
safe. Biotie's patient dossier for nalmefene includes approximately 1,100
patients and will expand to approximately 3,000 patients when all three
III studies being conducted by Lundbeck have been completed.
Nalmefene builds on a novel principle of treating alcohol dependence.
existing therapies, treatment with nalmefene is not aimed at keeping the
patients from drinking. Instead, nalmefene helps to control and limit the
of alcohol. Reduction of alcohol consumption to less harmful levels is
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
pharmaceuticals must be taken continuously over a longer period of time and
aimed at maintaining abstinence.
About the Phase III programme
Based on the results of earlier Biotie-sponsored trials, Lundbeck is
an extensive Phase III clinical trial programme for nalmefene in Europe,
including two 24-week efficacy studies (ESENSE1, ESENSE2) and a 52-week
term safety study (SENSE), enrolling in total around 2,000 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
tolerability of nalmefene, as well as to investigate the benefit of
over a prolonged period of time.
Nalmefene is a small molecule opioid receptor antagonist that inhibits the
reward pathway in the brain that reinforces the desire and craving for
and other addictive substances. As a result, nalmefene removes a person's
to drink. Biotie has licensed global rights to nalmefene to Lundbeck. Under
terms of the agreement, Biotie is eligible for up to EUR 84 million in
and milestone payments plus royalties on sales from Lundbeck. Biotie has
received EUR 12 million from Lundbeck. Further milestone payments are
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
which the afflicted person continually craves alcohol, is unable to limit
or her drinking, needs to drink greater amounts to get the same effect and
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
over 58 million adults (15%) consume above this level, with 20 million of
(6%) drinking the equivalent of 5 - 6 standard drinks every day. Looking at
addiction rather than drinking levels, it is estimated that 23 million
(5% of men, 1% of women) are dependent on alcohol in any one year.
Alcohol is the third leading cause of ill health after tobacco smoking and
hypertension; there are more risks associated with alcohol than with
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
a common problem in many parts of the world. One in ten deaths in the
world is alcohol-related. Despite this, alcoholism tends to be severely
diagnosed with only approximately 13% of alcohol dependants receiving
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
dependence patient. There are only a few pharmaceutical compounds that
received marketing approval to help alcoholics maintain abstinence. All
treatments, including psychosocial counseling measures, cannot prevent a
relapse rate of the patients and permanent cure is thus still the
rather than the rule.
There are no approved therapies on the market yet to proactively help curb
person's urge to drink.
Turku, 3 January 2011
Biotie Therapies Corp.
President and CEO
NASDAQ OMX Helsinki Ltd
About Biotie Therapies
Biotie is a specialized drug development company focused on central nervous
system and inflammatory diseases. It has several innovative small molecule
biological drug candidates at different stages of clinical development.
products address diseases with high unmet medical need and significant
potential, including addiction and a broad range of inflammatory conditions
as rheumatoid arthritis or chronic obstructive pulmonary disease (COPD).
most advanced product, nalmefene for alcohol dependence, is currently in
III clinical development by licensing partner H. Lundbeck A/S.
Biotie is based in Turku, Finland and its shares are listed on NASDAQ OMX
For more information, please refer to www.biotie.com
 Alcohol in Europe - A public health perspective; A report for the
Commission; June 2006
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Biotie Therapies Oyj via Thomson Reuters ONE