Lundbeck initiates clinical phase III trials with desmoteplase in ischemic stroke

H. Lundbeck A/S has initiated a clinical phase III programme with
desmoteplase in the treatment of acute ischemic stroke. The programme
consists of two phase III clinical placebo-controlled trials, each
enrolling approximately 320 patients.

Today, approximately 80% of stroke patients are not diagnosed and
ready for treatment until more than three hours after the stroke
takes place. The only currently approved medical treatment for
patients suffering from stroke must be applied within a maximum of
three hours after the stroke takes place.

Following consultations with health authorities the trials have been
designed with the aim of measuring efficacy of one dosage of
desmoteplase (90mg/kg) administered in a window of between three and
nine hours after the stroke has occurred. The two trials will enrol
patients internationally at sites in Europe, USA, Canada, South
America and Asia. The efficacy of desmoteplase will be assessed after
90 days."Desmoteplase has the potential to treat patients with acute
ischaemic stroke up to nine hours after onset of symptoms. That is up
to six hours more than existing treatment and will allow a large
group of patients time to reach the hospital and be treated", says
Executive Vice President Anders Gersel Pedersen, Head of Development
at Lundbeck. "Desmoteplase has the potential to become a significant
benefit to patients in an area with substantial unmet medical needs."

About desmoteplase
Desmoteplase, the most fibrin-specific plasminogen activator known
today, is a genetically engineered version of a clot-dissolving
protein found in the saliva of the vampire bat Desmodus rotundus. It
has received fast-track designation from the U.S. Food and Drug
Administration for the indication of acute ischemic stroke.

Patients in an earlier clinical phase III trial with desmoteplase
were eligible for treatment only in case of a detectable penumbra
(insufficiently perfused but still salvageable tissue area around the
primary location of stroke) of at least 20% of the affected area and
were not screened for presence of vessel occlusion in the larger
brain arteries using angiography. The data from the re-analysis of
angiographs from these patients demonstrated that, in contrast to the
phase II studies, 70% of the patients in the phase III trial lacked
visible vessel occlusion before treatment.

When analysing patient subgroups using presence of vessel occlusion
as treatment criteria, a reduced response rate on the placebo group
and a positive effect of desmoteplase versus placebo is observed,
however not statistically significant due to the small sample size.
Additionally, pooled results from the clinical phase II and III
studies show statistically significant efficacy in favour of
desmoteplase if patients without visible occlusions in the large
brain arteries are excluded. These novel findings are encouraging and
support continued clinical investigation in patients with acute
ischemic stroke within 3 to 9 hours after onset of stroke symptoms.

Lundbeck has obtained worldwide rights to desmoteplase from PAION AG
in Germany. PAION has been supporting in the planning of the new
trials.

About stroke
Stroke is the third leading cause of death in the industrialised
world and a leading cause of serious, long-term disability. In the US
alone, approximately 700,000 people suffer an ischemic stroke each
year, and around 8-12% of them die within 30 days. For the US, the
American Heart Association estimates the financial burden of stroke
due to in-hospital costs, long-term care programmes and productivity
losses to approximately USD 66 billion in 2008.

The content of this release will have no influence on the Lundbeck
Group's financial result for 2008.

Lundbeck contacts


Investors:                 Media:

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

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


Stock Exchange Release No 361 - 17 December 2008

About Lundbeck
H. Lundbeck A/S 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 2007, the company's revenue was DKK 11 billion
(approximately EUR 1.5 billion or USD 2.0 billion). The number of
employees is approx. 5,300 globally. For more information, please
visit www.lundbeck.com.