H. Lundbeck A — Major Shareholding Notification 2012

Sep 20, 2012

-- Lundbeck has filed an MAA via centralised procedure for regulatory approval
of vortioxetine (Lu AA21004) in Europe
-- The file is based on an extensive data package consisting of ten short and
long-term studies and includes statistically significant results supporting
the dose range from 5-20mg
-- Vortioxetine represents the first European centralised filing of a novel
antidepressant treatment since 2007
-- The multimodal activity profile of vortioxetine may translate into
therapeutic benefits in depression that current therapies do not
sufficiently address
-- Major depression is a leading cause of disability[1]. The WHO predicts
depression will become the leading cause of disability by the year 2030[2]

H. Lundbeck A/S (Lundbeck) today announced the submission to the European
Medicines Agency (EMA) of a marketing authorisation application (MAA) for the
approval of the investigational multimodal antidepressant vortioxetine (Lu
AA21004), and the dossier has been accepted for review. Vortioxetine belongs to
a new generation of antidepressants that has been developed for the treatment
of patients with major depressive episodes (MDE).

"I am very pleased that we now have filed vortioxetine in Europe as many people
suffering from major depression still struggle to find an effective treatment,"
says Executive Vice President Anders Gersel Pedersen, Head of Research &
Development at Lundbeck, and continues: "I am confident that the efficacy and
safety data available will support a successful MAA submission for vortioxetine
in major depression and we are currently working with our partner, Takeda, to
file the application in the US later in the year and in Japan next year."

The data package supporting the file is substantial, consisting of ten large,
placebo-controlled clinical short and long term studies in major depression
using dosages from 5 to 20 mg of vortioxetine. This data package includes
studies in relapse prevention and in elderly patients with major depression,
both of which were presented at the 165th Annual Psychiatric Association (APA)
Annual Meeting in May 2012.

Across the programme vortioxetine was generally well-tolerated. The most common
adverse event (AE) observed in patients receiving vortioxetine was nausea.

More than 5,000 individuals have been exposed to vortioxetine worldwide,
including the US, across the entire clinical trial programme. Statistically
significant results were established in major depression on all doses from 5 to
20mg in these studies.

Lundbeck plans to submit a new drug submission (NDS) to Health Canada for
vortioxetine during the second half of this year as well. Separately, Lundbeck
and Takeda, its partner in the US and Japan, plan to submit a new drug
application (NDA) to the US Food and Drug Administration (FDA) during the
fourth quarter of 2012 and in Japan during 2013.

Lundbeck plans to present further efficacy and safety data from its pivotal
clinical programme at the 166th APA Annual Meeting in San Francisco, USA, 18-22
May 2013.

Lundbeck is committed to further investigate the long-term efficacy and
tolerability of vortioxetine as well as its effects on cognitive symptoms
(expressed as difficulty concentrating, forgetfulness and inability to make
decisions) associated with depression. Vortioxetine’s potential effect on
cognitive symptoms was recently shown in a study in elderly patients suffering
from major depression, which was presented in May 2012 at the APA Annual
Meeting in Philadelphia[3] (Poster no. 8-44) and published in the journal
International Clinical Psychopharmacology[4].

About vortioxetine (Lu AA21004)
Vortioxetine is under investigation as a multimodal antidepressant that is
thought to work through a combination of two mechanisms of action: receptor
activity modulation and reuptake inhibition. In vitro studies indicate that
vortioxetine is a 5-HT3 and 5-HT7 receptor antagonist, 5-HT1B receptor partial
agonist, 5-HT1A receptor agonist and inhibitor of the serotonin transporter
(SERT). In vivo non-clinical studies have demonstrated that vortioxetine
enhances levels of the neurotransmitters serotonin, noradrenaline, dopamine,
acetylcholine and histamine in specific areas of the brain.

The multimodal activity profile of vortioxetine may translate into therapeutic
benefits in depression that current therapies do not sufficiently address.

About major depression
Major depression is a highly prevalent, serious and debilitating medical
condition and is associated with significant functional impairment and reduced
quality of life[5]. Depression is the leading worldwide cause of years lost due
to disability, and projected to be the biggest contributor to the worldwide
burden of disease by 2030. It is estimated that between a quarter and a third
of the population will develop at least one episode of major depression during
their life-time and of these as many as two thirds will have recurrent
episodes, and one third will develop a chronic condition.

While several pharmacological treatments are available, around 50% of patients
remain symptomatic following first-line treatment, and a third fail to achieve
full resolution of depressive symptoms after four established treatments. This
limited effectiveness by antidepressant treatments is multifactorial and can be
explained by, among other factors, the significant clinical heterogeneity of
the disease, tolerability factors and treatment adherence factors.

Both in clinical practise and clinical research the main focus in major
depressive disorder has been on mood symptoms. Primary measures in clinical
trials, eg the MADRS, reflect changes in a range of symptoms with an emphasis
on mood symptoms. The disease can though be described as a complex syndrome of
emotional, cognitive and somatic symptoms. The range of symptoms patients
experience includes cognitive symptoms such as difficulty concentrating,
forgetfulness and inability to make decisions. Persistence of cognitive
symptoms in patients with major depression can contribute to impaired work
function and predict poor occupational outcome.

The tolerability of antidepressants and patients' concerns about side effects
negatively affect patient outcomes. Patients with major depression who
experience at least one severe side effect are twice as likely to discontinue
treatment prematurely. Common reasons for premature treatment discontinuation
include weight gain, and gastrointestinal and sexual side effects.

Additional treatment strategies are needed to prevent and treat the common and
debilitating symptoms of depression.

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.

Lundbeck contacts

Investors: Media:

Palle Holm Olesen Mads Kronborg
Chief Specialist, Head of Investor Relations Media Relations Manager
palo@lundbeck.com mavk@lundbeck.com
+45 36 43 24 26 +45 36 43 28 51

Magnus Thorstholm Jensen Simon Mehl Augustesen
Investor Relations Officer International Media Specialist
matj@lundbeck.com smeh@lundbeck.com
+45 36 43 38 16 +45 36 43 49 80

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.

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.

[1] World Health Organisation;
http://www.who.int/mental_health/management/depression/definition/en/

[2] Murray CJL, Lopez AD: “The Global Burden of Disease: A Comprehensive
Assessment of Mortality and Disability from Diseases, Injuries and Risk Factors
in 1990 and Projected to 2020”. Geneva, Switzerland; World Health
Organization, 1996.

[3] Olsen et al: “Efficacy and Safety of Lu AA21004 in a Randomised,
Double-Blind, Placebo-controlled, Active-referenced, Fixed-dose Study in
Elderly Depressed Patients”; Poster NR8-44, APA2012

[4] Cornelius Katona et al: “A randomized, double-blind, placebo-controlled,
duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu
AA21004 in elderly patients with major depressive disorder”; International
Clinical Psychopharmacology; May 2012

[5] Tracy L. Greer et al.: "Defining and Measuring Functional Recovery from
depression"; CNS Drugs 2010; 24 (4): 264-284