Nalmefene completes clinical phase III programme - submission of the European Marketing Authorization Application (MAA) is expected by the end of 2011
* Lundbeck has now completed the second 6-months efficacy study in the overall
clinical phase III programme with nalmefene
* Nalmefene has a significant potential for helping individuals with alcohol
dependence in reducing their alcohol consumption and allowing individuals to
be in control of their alcohol intake
* The reduction in heavy drinking days and total alcohol consumption was seen
within the first month of treatment in all three studies and was maintained
throughout the 12-month safety study
* Nalmefene was safe and well tolerated
* Nalmefene is the first medicine aimed at regulatory approval in Europe for
the reduction of alcohol consumption in patients with alcohol dependence
consequently reducing the risk of alcohol related harm
* Submission of an MAA for nalmefene in Europe is expected by the end of 2011
H. Lundbeck A/S (Lundbeck) today announced the completion of the final study
(ESENSE2) in the phase III clinical programme for nalmefene in patients with
alcohol dependence. In this multi-center, double-blind, placebo-controlled
study, 718 individuals were randomized to receive oral administration of 20 mg
of nalmefene or placebo on an as-needed basis for a total of 28 weeks of
treatment.
"We are pleased that we now have reached a stage with nalmefene where we can
plan the regulatory process with an expected submission of the MAA towards the
end of the year" says Executive Vice President Anders Gersel Pedersen, Head of
Drug Development at Lundbeck, and continues: "Across the clinical phase III
programme consistency and robustness were observed and the studies support the
overall positive clinical profile of nalmefene".
During the clinical programme a wide range of primary and secondary endpoints
were assessed, including number of heavy drinking days per month (HDD), total
alcohol consumption in grams per day (TAC), 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, though some were not statistically significant at
every single time point. It was consistently observed that the medical
intervention with nalmefene had a strong effect that was seen within the first
month and led to a reduction in alcohol consumption of over 50% and was
maintained throughout the study periods.
The three studies in the overall phase III clinical programme were conducted in
Europe and enrolled about 2,000 individuals with alcohol dependence. A medical
compliance encouragement programme was included in all treatment arms in the
studies. No abstinence treatment goals were imposed. The data from ESENSE2 is
consistent with the profile seen in previous clinical studies of nalmefene. In
all three clinical studies the overall safety profile of nalmefene was
consistent with observations and data provided in previous studies making a
total clinical database of more than 3,000 individuals. The most frequent
adverse events included dizziness, insomnia and nausea and were mild and
transient upon stopping treatment.
Heavy drinking level is defined as five or more drinks per day for men and four
or more drinks per day for women. Individuals on 20 mg nalmefene had after 6
months of treatment a decrease of heavy drinking days by more than 50%.
Furthermore, data from the 12 month safety study (SENSE) confirmed that this
effect is maintained and even improved after 1 year of treatment; leading to
more than 60% overall reduction in total alcohol consumption. Approximately 2/3
of the individuals in the studies have not been treated for alcohol dependence
before, indicating that reduction of alcohol intake is an attractive alternative
treatment objective compared to current treatments which all require abstinence.
Lundbeck plans to submit a European Marketing Authorization Application (MAA)
for nalmefene as a treatment for alcohol dependence towards the end of 2011. The
presentation of the efficacy and safety data at scientific meetings and
conferences is planned during the next 12 months.
Nalmefene builds on a novel principle of treating alcohol dependence. Unlike
existing therapies, the treatment with nalmefene can be used on an as-needed
basis allowing individuals to be in control of their treatment and limit the
intake of alcohol rather than requiring full abstinence. Reduction of alcohol
consumption to less harmful levels is supported by specialists as a valuable
treatment option to keep the individuals in treatment and to increase the
willingness among patients to initiate treatment. In addition, nalmefene
distinguishes itself by being available as a tablet formulation to be taken only
according to need, whereas existing pharmaco-therapies must be taken
continuously over a longer period of time and with the aim of maintaining
abstinence.
About the clinical phase III programme
Based on the results of earlier trials, Lundbeck initiated three phase III
clinical studies in Europe in 2008 enrolling a total of approximately 2,000
individuals randomised into two groups receiving nalmefene (20 mg as needed,
orally) and placebo in addition to a brief medical compliance encouragement
programme. Two of the three trials (ESENSE1 and ESENSE2), in which individuals
were treated over a period of six months, primarily aimed to demonstrate the
efficacy of nalmefene, whilst the primary objective of the third study (SENSE),
in which individuals were treated for 12 months, was to confirm the safety and
tolerability of the compound.
About nalmefene
Nalmefene is a selective opioid receptor ligand with antagonist activity at mu
and delta opioid receptors and partial agonistic activity at the kappa opioid
receptor. This pharmacological profile helps to control and reduce alcohol
intake.
Nalmefene was originally developed by Key Pharmaceuticals and IVAX/Baker Norton
in the 1980s and 1990s. Biotie Therapies Corp. (Biotie) in Finland obtained the
rights to the compound in 1998 and started clinical development within alcohol
disorders in 1999. In 2006, Lundbeck licensed the rights to nalmefene from
Biotie. Under the terms of the agreement, Biotie received an execution fee of
EUR 12 million. In total, Biotie is eligible for up to EUR 84 million in upfront
and milestone payments plus royalty on sales. Lundbeck will be responsible for
manufacturing and registration of the product.
Lundbeck holds the global rights to the compound.
About alcohol dependence
Alcohol dependence is a disorder of the central nervous system with a chronic,
relapsing, and often progressive course. Alcohol affects chemical pathways in
the brain, and long-term exposure increases the rewarding effects of alcohol and
reduces the control over consumption in vulnerable people. Research
suggests that genetic and environmental factors contribute about equally to the
risk of developing alcohol dependence.
Alcohol is toxic to most organs, and its use is linked to several diseases
including cancer and cardiovascular diseases. Alcohol is a significant threat to
public health, social welfare and economic development. It is estimated that in
any given year, 5.0% of adult men and 1.4% of adult women in the EU will suffer
from alcohol dependence, with large differences across nations[1].
Financial guidance
The content of this release will have no influence on the Lundbeck Group's
financial guidance for 2011 which was provided on 24 February 2011 in connection
with the release of the financial results for 2010.
Lundbeck contacts
Investors: Media:
Palle Holm Olesen Mads Kronborg
Chief Specialist, Investor Relations Media Relations Manager
+45 36 43 24 26 +45 36 43 28 51
Magnus Thorstholm Jensen Simon Mehl Augustesen
Investor Relations Officer International Media Specialist
+45 36 43 38 16 +45 36 43 49 80
Jacob Tolstrup
Vice President
+1 847 282 5713
About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical
company highly committed to improving the quality of life for people suffering
from central nervous system (CNS) disorders. For this purpose, Lundbeck is
engaged in the research, development, production, marketing and sale of
pharmaceuticals across the world. The company's products are targeted at
disorders such as depression and anxiety, schizophrenia, insomnia, epilepsy and
Huntington's, Alzheimer's and Parkinson's diseases.
Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark. Today
Lundbeck employs approximately 5,900 people worldwide. Lundbeck is one of the
world's leading pharmaceutical companies working with CNS disorders. In 2010,
the company's revenue was DKK 14.8 billion (approximately EUR 2.0 billion or USD
2.6 billion). For more information, please visit www.lundbeck.com.
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[1] Jürgen Rehm et al.: "Alcohol use disorders in EU countries and Norway: An
overview of the epidemiology"; European Neuropsychopharmacology 15 (2005)
377-388
[HUG#1523497]
