FDA Advisory Committee provides opinion on Serdolect® for the treatment of schizophrenia

H. Lundbeck A/S (LUN.CO; LUN DC) announced today that the
Psychopharmacology Drug Advisory Committee (PDAC) appointed by the
U.S. Food and Drug Administration (FDA) voted unanimously that
Serdolect® (sertindole) is efficacious in the treatment of patients
with schizophrenia, though they did not find the data robust enough
to support an additional regulatory claim related to treatment of
suicidal behaviour in schizophrenia. The majority of the committee
voted against its use in a broad schizophrenia population due to
safety concerns, however a majority of the committee voted that there
may be subpopulations in which the therapy is beneficial with
appropriate labeling and risk management tools. Lundbeck will work
closely with the agency to define the appropriate indication and risk
management program to support approval of Serdolect®.

The FDA is not bound by the committee's recommendation, but usually
follows its advice. The target Prescription Drug User Fee Act (PDUFA)
date for the Serdolect® application is May 15, 2009. If approved,
Lundbeck Inc., the company's wholly owned U.S. subsidiary, will
market the product."We are pleased with the Advisory Committee's recommendation in
support of the efficacy of Serdolect® in the treatment of
schizophrenia and the acknowledgement of its potential safe use in
the right populations with appropriate risk management measures as it
is important for patients to have multiple treatment options," said
Executive Vice President Anders Gersel Pedersen, Head of Drug
Development at Lundbeck. "There continues to be a significant unmet
medical need for a less sedating treatment for people with
schizophrenia who may experience impaired cognition with other
existing therapies and for a medication to treat suicidality in
schizophrenia. We will continue to work closely with the FDA as the
agency moves toward an action on the new drug application for
Serdolect®."

The committee reviewed comprehensive data from clinical trials.
Results from short-term, double-blind, fixed-dose, placebo- and
active-controlled studies demonstrated that Serdolect® was superior
to placebo in treating the positive and negative symptoms associated
with acute exacerbation of schizophrenia.

With nearly 10,000 patients and approximately 15,000 patient years of
exposure, the Sertindole Cohort Prospective (SCoP) study showed that
the all-cause mortality with Serdolect® was comparable to that with
risperidone. During randomised treatment (only Serdolect® or
risperidone), the all-cause mortality rate for Serdolect® was 0.63
deaths per 100 patient years, which was the same as that observed for
risperidone.

The outcome of the SCoP study further confirmed that although a
higher cardiovascular event rate is seen for patients treated with
Serdolect®, the event rate related to arrhythmia remains very low.

About Serdolect®
Serdolect® has an inhibitory effect on central dopamine D2 and
serotonin 5HT2 receptors as well as on alpha-adrenergic receptors.
Serdolect® is an antipsychotic drug for the treatment of
schizophrenia without sedative effect and with placebo level
extrapyramidal symptoms (EPS). The safety and efficacy of Serdolect®
have been studied extensively and the studies demonstrate that:
-       Serdolect® reduces the positive and negative symptoms
associated with acute exacerbation of schizophrenia.
-       Data suggest that Serdolect® may reduce the risk of suicide
and suicide attempt in patients with schizophrenia, including those
at high risk of suicide.
-       Serdolect® is well tolerated and non-sedating, and has a
placebo-level incidence of EPS.
-       Serdolect®'s effect on the QT interval is well characterised,
non-clinically and clinically, and the risk of arrhythmia is low.
-       The outcome of the SCoP study, a large, simple, randomised,
mortality study, confirmed that all-cause mortality for Serdolect® in
patients with schizophrenia is comparable to a standard treatment
(risperidone).

The efficacy, tolerability and safety of Serdolect® has through daily
clinical practice been characterised in more than 40,000 patient
years exposure.

Serdolect® received marketing approval for the treatment of
schizophrenia from the European Commission on 20 December 2005.
Serdolect® is launched in 40 countries worldwide.  It is not yet
approved for use in the United States.

Serdolect® derives from Lundbeck's in-house research and the company
holds the global rights.

Important Safety Information
Serdolect® (sertindole) has been shown to prolong the QT interval in
a dose dependent manner.  Some drugs that prolong the QT interval
have been associated with the occurrence of Torsades de Pointes and
with sudden unexplained death.  Serdolect® is contraindicated in
patients with a history of QT prolongation and in patients with
clinically significant cardiovascular disease.  Serdolect® should not
be initiated in patients with a prolonged QT interval and should be
discontinued in patients who are found to have persistent QTc
measurements > 500 msec.

Serdolect® is also contraindicated in patients receiving drugs known
to significantly prolong the QT interval, in patients treated with
potent inhibitors of CYP3A, in patients with uncorrected hypokalemia
and hypomagnesaemia and in patients with severe hepatic impairment.
Increased mortality has been reported in elderly patients with
dementia-related psychosis who receive anti-psychotic
agents. Neuroleptic malignant syndrome, tardive dyskinesia,
hyperglycemia and diabetes mellitus, orthostatic hypotension,
seizures and hyperprolactinemia have also been reported with
Serdolect® use.

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
Lundbeck expects to provide financial guidance in connection with the
half-year report 2009 at the latest.


Lundbeck contacts


Investors:                 Media:

Jacob Tolstrup             Mads Vindahl Kronborg
Director                   Media Relations Manager
+45 36 43 30 79            +45 36 43 28 51

Palle Holm Olesen          Sally Benjamin Young (USA)
Head of Investor Relations VP, Communications
+45 36 43 24 26            Lundbeck Inc.
                           +1 (847) 727-3265


About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international
pharmaceutical company engaged in the research and development,
production, marketing and sale of pharmaceuticals for the treatment
of psychiatric and neurological disorders. In 2008, the company's
revenue was DKK 11.3 billion (approximately EUR 1.5 billion or USD
2.2 billion). The number of employees is approx 5,500 globally. For
more information, please visit www.lundbeck.com.