H. Lundbeck (CPH:LUN) Lundbeck Moves Lu AA39959 Into Clinical Phase II For The Treatment Of Patients With Bipolar Disorder

H. Lundbeck (CPH:LUN) 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

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H. Lundbeck

http://www.lundbeck.com

ISIN: DK0010287234

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