Lundbeck provides update on NDA for Serdolect® for the treatment of schizophreni



H. Lundbeck A/S (LUN.CO; LUN DC) announced today that it has not yet
received an action letter from the US Food and Drug Administration
(FDA) for the New Drug Application (NDA) for Serdolect® (sertindole)
for the treatment of schizophrenia. The company anticipated receipt
of the action letter on May 15, 2009, the originally assigned
Prescription Drug User Fee Act (PDUFA) date. The FDA informed the
company that they would receive the action letter as soon as
possible.

About Serdolect
Serdolect® derives from Lundbeck's in-house research and the company
holds the global rights. Serdolect® has a unique neuropharmacological
profile, characterized by inhibitory effects on dopamine D2,
serotonin 5-HT2 and 5-HT6 receptors, as well as on alpha1-adrenergic
receptors. Serdolect® has a high limbic selectivity, indicating
antipsychotic activity without potential for extrapyramidal motor
side effects. It has no effect on muscarinic cholinergic and
histamine H1 receptors, which could be associated with cognitive and
sedative side effects. The preclinical profile has been confirmed in
clinical trials

About schizophrenia
Schizophrenia is a serious and often chronic mental disorder
affecting up to one percent of the world's population. In many
patients the disorders start during late adolescence or early
adulthood leading to severe changes in the patient's way of thinking
and perceiving the outside world.

During the course of the illness, periods during which the patient is
in an acute psychotic condition and suffering from definite
hallucinations and delusions alternate with more stable periods
during which the patient experiences a significant reduction in
symptoms. However, even in stable periods, many patients have
difficulty in establishing social contact, completing an education
programme or holding a normal job. Schizophrenia patients may have
significant difficulties in performing daily activities necessary for
independent living. The occurrence of suicide and suicidal behaviour
is a major burden for patients, families and society. Suicide is a
leading cause of premature deaths among patients with schizophrenia.
Schizophrenia is also associated with increased medical morbidity
like respiratory or cardiovascular diseases which all contribute to a
significantly lower life expectancy.

The disorder is often disabling and produces important emotional and
financial hardship for the patient and the patient's family.
Furthermore, schizophrenia causes a major economic burden to society,
not only due to the direct treatment costs but also because of a
reduced ability to work forcing many patients to claim disability or
pensions.


Financial guidance
The content of this release will have no influence on the Lundbeck
Group's financial result for 2009.


Lundbeck contacts


Investors:                   Media:

Jacob Tolstrup               Mads Kronborg
Director, IR & Communication Media Relations
+45 36 43 30 79              +45 36 43 28 51

Palle Holm Olesen
Head of Investor Relations
+45 36 43 24 26


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, Alzheimer's and Parkinson's
diseases.

Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark,
and employs today over 5.500 people worldwide. Lundbeck is one of the
world's leading pharmaceutical companies working with CNS disorders.
In 2008, the company's revenue was DKK 11.3 billion (approximately
EUR 1.5 billion or USD 2.2 billion). For more information, please
visit www.lundbeck.com.

Attachments

Release no 374.pdf