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  • First two clinical phase III studies confirm the profile of nalmefene as efficacious and safe in helping individuals to reduce their alcohol consumption

First two clinical phase III studies confirm the profile of nalmefene as efficacious and safe in helping individuals to reduce their alcohol consumption

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  * Lundbeck has completed a short-term efficacy study and a long-term safety
    study in the overall pivotal programme with nalmefene
  * The pivotal programme also includes an additional second short-term efficacy
    study which will be reported in the second quarter of 2011
  * Nalmefene is on track for submission of the MAA in Europe in the second half
    of 2011 pending successful completion of the last pivotal efficacy study
  * The efficacy data obtained so far demonstrate that nalmefene is the first
    potential treatment alternative for many people in need of a reduction of
    their total alcohol consumption
  * The data from the two studies is consistent with the profile seen in
    previous clinical studies
  * Reduction in alcohol consumption is an important step in reducing the
    significant medical and societal burden associated with alcohol dependence

H. Lundbeck A/S (Lundbeck) today announced the completion of two out of three
pivotal studies in the phase III clinical programme for nalmefene in alcohol
dependence (ESENSE1 and SENSE). The studies were conducted in Europe and
enrolled about 1,300 patients with alcohol dependence. A concomitant
psychosocial intervention in the studies was a brief, standardised programme
focussed on adherence and follow-up. No abstinence treatment goals were imposed.

In both studies the overall safety profile of nalmefene was consistent with
observations and data provided in previous studies. The most frequent adverse
events included dizziness, insomnia and nausea.

"We are pleased that these data demonstrate that nalmefene is on track to become
the first drug to make a difference for the many people in need of a reduction
of their harmful alcohol consumption" says Executive Vice President Anders
Gersel Pedersen, Head of Drug Development at Lundbeck, and continues: "We will
now finalise the last efficacy study in the programme to assess the full data
package in order for us to prepare the registration of nalmefene in Europe."

We expect to complete the third and final phase III study (ESENSE 2) in the
second quarter of 2011. Lundbeck will be initiating a dialogue with the
healthcare agencies as well as scientific advisors to discuss the study outcomes
and the plans for submitting a European Marketing Authorization Application
(MAA) for nalmefene as a treatment for alcohol dependence. It is Lundbeck's view
that nalmefene is on track for submission of the European MAA in the second half
of 2011, but it will as planned depend on the outcome of the final short-term
pivotal efficacy study. The presentation of the efficacy and safety data at
scientific meetings and conferences is planned following the completion of all
three pivotal studies.

Nalmefene builds on a novel principle of treating alcohol dependence. Unlike
existing therapies, the treatment with nalmefene is not aimed at keeping the
patients from drinking. Instead, nalmefene helps to control and limiting the
intake of alcohol. Reduction of alcohol consumption to less harmful levels is
supported by specialists as a valuable treatment option to keep the patients 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 pharmaceuticals
must be taken continuously over a longer period of time and for the aim of
maintaining abstinence.

About the clinical phase III programme
Based on the results of earlier trials, Lundbeck has initiated three phase III
trials in Europe enrolling approximately 2,000 patients randomised into two
groups receiving nalmefene (20 mg as needed, orally) and placebo, respectively.
Two of the three trials (ESENSE1 and ESENSE2), in which patients 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
patients are treated for 12 months, is to confirm the safety and tolerability of
the compound.

About nalmefene
Nalmefene is an opioid receptor antagonist. The compound acts by blocking a
mechanism in the brain that can cause a continuing and uncontrolled intake of
alcohol. This 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 purchased 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 in its territory.

Lundbeck holds the global rights to the compound.

About alcohol dependence
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 at over 40g (women) or 60g per day
(men). 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[i].

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.

Alcohol dependence remains a highly stigmatised, under-diagnosed and
undertreated disease.

Financial guidance
The content of this release will have no influence on the Lundbeck Group's
financial guidance for 2010 which was provided on 4 March 2010 in connection
with the release of the financial results for 2009 and further specified with
the release of the third quarter report on 3 November 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             Stine Hove Marsling

Investor Relations Officer           External Communication Specialist

+45 36 43 38 16                      +45 36 43 28 33



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 and 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 2009,
the company's revenue was DKK 13.7 billion (approximately EUR 1.8 billion or USD
2.6 billion). For more information, please visit www.lundbeck.com.


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[i] Alcohol in Europe - A public health perspective; A report for the European
Commission; June 2006

[HUG#1476586]

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