H. Lundbeck A — Earnings Release 2011

Dec 14, 2012

-- The Committee for Medicinal Products for Human Use (CHMP) recommends
approval of Selincro(TM) for the reduction of alcohol consumption in adult
patients with alcohol dependence who have a high level of alcohol
consumption
-- Upon final marketing authorisation from the EU Commission, Selincro will be
the first medicine to provide a new treatment option for alcohol dependence
that is based on the harm reduction concept
-- There is a significant unmet need as alcohol dependence is both
underdiagnosed and undertreated. In Europe more than 90% of patients with
alcohol dependence are currently untreated1
-- In Europe the impact of alcohol is the highest in the world, with 12% of
all deaths in the age group of 15-64 attributable to alcohol2

H. Lundbeck A/S (Lundbeck) today announced that the Committee for Medicinal
Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted
a positive opinion and recommended marketing authorization of Selincro for the
reduction of alcohol consumption in adult patients with alcohol dependence who
maintain 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.

For many patients with alcohol dependence, to entirely stop and abstain from
drinking is not an acceptable or attainable treatment goal. Selincro will be
the first medication specifically developed for the reduction of alcohol
consumption in patients with alcohol dependence who maintain a high level of
alcohol consumption. Selincro reduces alcohol consumption and thus the
consequences of harmful drinking, and offers a new treatment option for
patients who may not have sought treatment before.

“Selincro represents the first major innovation in the treatment of alcohol
dependence in many years. Selincro reduces the urge to continue drinking and
helps patients with alcohol dependence to reduce their alcohol consumption,"
says Executive Vice President Anders Gersel Pedersen, Head of Research &
Development at Lundbeck, and continues: "The Committee’s support of Selincro
brings us closer to encouraging more patients with alcohol dependence to
potentially seek help and treatment."

Selincro is an opioid system modulator3,4 that works on the brain’s
motivational system, which is dysregulated in patients with alcohol
dependence.5 Selincro is thought to reduce the reinforcing effects of alcohol.6

The CHMP opinion was based on the results from three pivotal, randomized,
double-blind, placebo controlled clinical trials studying the effects of 18mg
Selincro in adults 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.

For approval, the efficacy of Selincro 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 was 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.

The European Commission usually delivers its final decision 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.

Financial guidance
The content of this release will have no influence on the Lundbeck Group's
financial guidance for 2012, which was provided on 8 February 2012 in
connection with the release of the financial results for 2011, and further
specified in connection with the announcement of the restructuring plan on 14
June 2012.

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 (>60g/day for men, >40g/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.

Lundbeck licensed the rights to Selincro from Finnish Biotie Therapies Corp.
(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 89 million in
upfront and milestone payments plus royalty on sales. Lundbeck holds the global
rights to the compound and 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.7,8 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.9 Alcohol is a causal factor in more than 60 types of
disease and injury.10 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.11 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 consequences.12

Excessive alcohol consumption is common in many parts of the world, especially
in Europe where more than 14 million people are alcohol dependent.9,13 In
Europe the treatment gap is very large, with only 8% of patients receiving any
treatment.1 Both abstinence and reduction goals should be considered as part of
a comprehensive treatment approach for patients with alcohol dependence.14

Lundbeck contacts

Investors: Media:

Palle Holm Olesen Simon Mehl Augustesen
Chief Specialist, Head of Investor Relations International Media Specialist
palo@lundbeck.com smeh@lundbeck.com
+45 36 43 24 26 +45 36 43 49 80

Magnus Thorstholm Jensen
Investor Relations Officer
matj@lundbeck.com
+45 36 43 38 16

About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is an international pharmaceutical
company highly committed to improving the quality of life for people suffering
from brain 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, psychotic disorders, 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 6,000 people worldwide. Lundbeck is one of the
world’s leading pharmaceutical companies working with brain disorders. In 2011,
the company's revenue was DKK 16.0 billion (approximately EUR 2.1 billion or
USD 3.0 billion). For more information, please visit www.lundbeck.com.

References:

1Kohn et al. Bull World Health Organ 2004; 82(11):858-866
2Rehm et al. CAMH. Alcohol consumption, alcohol dependence and attributable
burden of disease in Europe
http://www.camh.ca/en/research/news_and_publications/reports_and_books/Pages/def
ault.aspx
3Michel et al. Meth Find Exp Clin Pharmacol 1985; 7: 175-177
4Hillemacher et al. Expert Opin. Investig. Drugs 2011; 20(8): 1073-1086
5Heinz et al. Addict Biol 2009; 14(1): 108-118
6Spanagel & Valentina. Curr Topics Behav Neurosci 2013; 13: 583–609
7Burge et al. Am Fam Physician 1999; 59(2): 361-370
8Leshner. Science 1997; 278: 45-47
9Rehm et al. Eur Addict Res 2003; 9: 147-156
10WHO. Global status report on alcohol and health, 2011
11Schuckit. Ch. 98. In: Davis et al (eds). Neuropsychopharmacology: The Fifth
Generation of Progress. 2002
12WHO, ICD-10, F10-19
13Wittchen et al. Eur Neuropsychopharmacol 2011;21(9): 655-679
14Ambrogne. J Subst Abuse Treat 2002; 22(1): 45-53

Safe Harbor/Forward-Looking Statements
The above information contains forward-looking statements that provide our
expectations or forecasts of future events such as new product introductions,
product approvals and financial performance.

Such forward-looking statements are subject to risks, uncertainties and
inaccurate assumptions. This may cause actual results to differ materially from
expectations and it may cause any or all of our forward-looking statements here
or in other publications to be wrong. Factors that may affect future results
include interest rate and currency exchange rate fluctuations, delay or failure
of development projects, production problems, unexpected contract breaches or
terminations, government-mandated or market-driven price decreases for
Lundbeck's products, introduction of competing products, Lundbeck's ability to
successfully market both new and existing products, exposure to product
liability and other lawsuits, changes in reimbursement rules and governmental
laws and related interpretation thereof, and unexpected growth in costs and
expenses.

Certain assumptions made by Lundbeck are required by Danish Securities Law for
full disclosure of material corporate information. Some assumptions, including
assumptions relating to sales associated with product that is prescribed for
unapproved uses, are made taking into account past performances of other
similar drugs for similar disease states or past performance of the same drug
in other regions where the product is currently marketed. It is important to
note that although physicians may, as part of their freedom to practice
medicine in the US, prescribe approved drugs for any use they deem appropriate,
including unapproved uses, at Lundbeck promotion of unapproved uses is strictly
prohibited.