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
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
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
---------------------------
[1] Alcohol in Europe - A public health perspective; A report for the
European
Commission; June 2006
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Source: Biotie Therapies Oyj via Thomson Reuters ONE
[HUG#1476577]
