Lundbeck moves Lu AA39959 into clinical phase II for the treatment of patients with bipolar disorder

H. Lundbeck A/S strengthens its pipeline of pharmaceuticals in
clinical development by initiating clinical phase II trials with Lu
AA39959. The decision is based on positive pre-clinical results as
well as positive conclusions of the phase I trials in healthy
individuals.

Lu AA39959 is first-in-class with a unique target profile.
Pre-clinical studies in animal models have shown anti-psychotic-like
as well as anti-depressant-like effects, and Lu AA39959 is expected
to show clear and convincing effects in patients with bipolar
disorder (also called manic-depressive illness or manic depression),
and is also likely to be associated with attractive
safety/tolerability profile and additional features, such as low
switch-rate to mania.

The clinical phase II study is placebo-controlled and
quetiapine-referenced, using a fixed dose of Lu AA39959 in the
treatment of patients with Bipolar I or II disorder. The study will
include 180 patients in three arms (15 mg Lu AA39959 twice daily,
placebo and quetiapine). The primary outcome measure will be
reduction of depressive symptoms as measured by the change from
baseline in total MADRS score after 8 weeks. Lu AA39959 affects
recently discovered ion channels expressed in the central nervous
system and this is the first time this mechanism of action is
investigated in patients with bipolar disorder."Lu AA39959 appears well tolerated in phase I studies and represents
a complete novel approach to the treatment of bipolar disorder. The
preclinical profile of Lu AA39959 suggests that the compound, in
addition to its anti-depressant-like effect, also possesses the
ability to treat manic as well as psychotic symptoms" says Executive
Vice President Anders Gersel Pedersen, Head of Drug Development at
Lundbeck. "We are very pleased with this further strengthening of
Lundbeck's development pipeline."


About Bipolar disorder
Bipolar disorder is a chronic and debilitating psychiatric illness
characterized by recurrent episodes of mania or depression, or a
mixture of both. Bipolar disorder is a complex, difficult-to-diagnose
illness accompanied by significant morbidity and mortality.
Individuals with unmanaged bipolar disorder can experience
significant decreases in their levels of functioning, including
decreased performance in day-to-day activities and damaged personal
relationships.

The World Health Organization (WHO) has identified bipolar disorder
as the sixth leading cause of disability-adjusted life years among
people aged 15-44 years worldwide[i], and much of this disability is
now thought to be due to depressive symptomatology[ii].

Decision Resources estimates that in 2006 the prevalence of bipolar
disorders exceeded 5 million individuals in the seven major markets
under study. Bipolar I disorder constitutes the majority of these
cases (approximately 68%).


Lundbeck contacts


Investors:                 Media:

Jacob Tolstrup             Jens Harder Højbjerg
Director                   Media Relations Manager
+45 36 43 30 79            +45 36 43 28 33

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


Release No 363 - 19 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.
[i] Pini S, et al. Prevalence and burden of bipolar disorders in
European countries. Eur Neuropsychopharmacol. 2005
[ii] Judd LL, et al. The long-term natural history of the weekly
symptomatic status of bipolar I disorder. Arch Gen Psychiatry.
2002;59:530-537