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First patients recruited in the extended phase III programme using Lu AA21004 in MDD

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H. Lundbeck A/S (Lundbeck) today announced that the first patients have been
recruited and dosed in the new phase III programme using Lu AA21004 in major
depression (MDD). The first patients have been recruited in Finland.

As previously communicated filing of Lu AA21004 is anticipated in 2012. The
extended phase III programme for Lu AA21004 is based on clinical data obtained
until now. Available data show encouraging results for the potential efficacy
and the tolerability profile of Lu AA21004:

  * A European based 560-patient placebo-controlled MDD study shows statistical
    significance on the primary efficacy endpoint across all tested doses.
  * Additionally a 639-patient relapse prevention study shows statistical
    significance in maintenance of efficacy in long-term treatment of MDD.
  * Supportive study shows separation from placebo with 5 and 10 mg doses.
  * Finally, the proof of concept study (clinical phase II) shows statistical
    significance on all tested doses

The phase III programme aims to recruit patients from Europe, as well as the US
and Canada in cooperation with our partner Takeda Pharmaceutical Company Limited
(Takeda).

About Lu AA21004
Lu AA21004 is an investigational multi-modal antidepressant that combines two
pharmacological modes of action; reuptake inhibition and receptor activity. Lu
AA21004 is a 5-HT(3), 5-HT(7) and 5-HT(1B) receptor antagonist, 5‑HT(1A)
receptor agonist and 5-HT transporter inhibitor. A number of investigations in
vivo have demonstrated that Lu AA21004 increases extracellular monoamine (5-HT,
noradrenaline and dopamine) and acetylcholine and histamine levels in specific
areas of the brain. All of these activities are considered to be of clinical
relevance and potentially involved in the mechanism of action of Lu AA21004.

Lu AA21004 has demonstrated a low drug-drug interaction potential. It is
extensively metabolized in the liver and the absorption of Lu AA21004 is
independent of food intake.

About depression
Depression is a very common, debilitating illness affecting around 121 million
people worldwide according to WHO. Depression was the leading cause of
disability as measured by YLD (Years of Life lived with Disability) and the 4th
leading contributor to the global burden of disease as measured by DALYs
(Disability Adjusted Life Year) in 2000. By the year 2020, depression is
projected to reach 2(nd) place of the ranking of DALYs calculated for all ages,
both sexes.

The symptoms of depression can be chronic or recurrent, and impact patients both
mentally and physically, yet it is still under-recognized and undertreated with
less than 25 percent of those affected having access to adequate treatment for
their condition[1].

Symptoms can include feelings of sadness, anxiety, loss of interest in
activities, decreased energy, impaired sleep, impaired concentration,
hopelessness, guilt, persistent physical symptoms such as pain and digestive
disorders, and in more severe cases, suicidal thoughts and suicide attempts.

Takeda and Lundbeck alliance
In September 2007, Lundbeck and Takeda formed a strategic alliance for the
exclusive co-development and co-commercialization in the United States and Japan
of several compounds in Lundbeck's pipeline for the treatment of mood and
anxiety disorders. The partnership initially focuses on co-development and
co-commercialization of the two most advanced compounds in Lundbeck's pipeline
for mood and anxiety disorders, Lu AA21004 and Lu AA24530. Once approved, the
companies will co-promote the products in the United States and Japan.

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.


Lundbeck contacts


Investors:                           Media:



Jacob Tolstrup                       Mads Kronborg

Vice President, IR & Communication   Media Relations Manager

+45 36 43 30 79                      +45 36 43 28 51



Palle Holm Olesen                    Stine Hove Marsling

Chief Specialist; Investor Relations External Communication Specialist

+45 36 43 24 26                      +45 36 43 28 33



Magnus Thorstholm Jensen

Investor Relations Officer

+45 36 43 38 16



About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical
company highly committed to improve 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, targeted at disorders like depression and
anxiety, schizophrenia, insomnia, Huntington's, epilepsies, Alzheimer's and
Parkinson's diseases.

Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark, and
employs today 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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[1] http://www.who.int/mental_health/management/depression/definition/en/


[HUG#1419090]

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