Data from four clinical phase III studies of Lu AA21004 presented for the first time at the 2011 Annual Meeting of the American Psychiatric Association (APA)
* Data showed that in two studies (one short-term and one long-term) of adult
patients with major depressive disorder (MDD), Lu AA21004 had statistically
significant separation from baseline versus placebo on the primary
endpoints. In these studies, findings of the secondary outcome measures were
supportive for both the 5 mg/day and 10 mg/day doses
* In two studies, none of the active treatment groups significantly differed
from placebo on the primary endpoint, including the active reference
duloxetine in one of these studies
* Data showed that Lu AA21004 is effective in preventing relapse in the adult
patients studied with MDD
* In the four studies, the majority of adverse events (AE) were considered
mild to moderate in severity across the Lu AA21004 dose groups
* Effects of higher doses (10-20 mg) than previously studied are being
investigated in ongoing clinical phase III studies
* Lu AA21004 is planned to be submitted for U.S. and European registration
during 2012
H. Lundbeck A/S (Lundbeck) today announced the presentation of new data from the
clinical phase III program of Lu AA21004, an investigational compound for the
treatment of adult patients with major depressive disorder (MDD), at the 2011
Annual Meeting of the American Psychiatric Association (APA) in Honolulu,
Hawaii. The presentations included results from four placebo-controlled clinical
phase III studies as well as pre-clinical data.
"The data from the phase III studies continue to support Lu AA21004 as a
multimodal anti-depressant based on its safety, efficacy as well as its relapse
prevention profile", says Executive Vice President Anders Gersel Pedersen, Head
of Drug Development at Lundbeck, and continues: "With the ongoing development
programme of Lu AA21004, we are building on Lundbeck's market leadership
position and our commitment to advancing medical treatment for one of the most
prevalent and debilitating psychiatric disorders."
The annual meeting of the APA is one of the largest scientific meetings for
psychiatrists and other healthcare professionals involved in psychiatric
research and psychiatric care.
In the U.S., Lundbeck is partnering with Takeda Global Research and Development
Center Inc., U.S. on the co-development and co-commercialization of this
compound. There are currently four ongoing short-term depression studies and two
long-term safety studies.
APA2011 presentation summaries:
Abstract: Efficacy and tolerability of multiple doses of Lu AA21004 in an 8-week
treatment of adults with major depressive disorder
Henigsberg, N., MD, DSc; Mahableshwarkar, A.R., MD; Jacobsen, P., MS; Chen, Y.,
PhD; Thase, M.E., MD
The results of this phase III, multicenter, randomized, double-blind, placebo-
controlled clinical trial of Lu AA21004 in 560 adult patients with MDD, showed
significant reduction in Hamilton Depression Rating Scale (HAM-D24) scores for
all Lu AA21004 treatment groups (1 mg, 5 mg, 10 mg) compared with placebo after
8 weeks of treatment (p>0.0001). The most common treatment emergent adverse
events (i.e., those reported by at least 10 percent of Lu AA21004 patients, and
twice the rate of placebo) were nausea, headache and dizziness.
Abstract: A double-blind, randomised, placebo-controlled, relapse-prevention
study with Lu AA21004 in patients with major depressive disorder
J-P Boulenger, M.D., Marianne Dragheim, M.D., Henrik Loft, M.Sc., Ioana Florea,
M.D.
To evaluate the long-term efficacy and tolerability of Lu AA21004, a phase III,
multicenter, randomized, double-blind, placebo-controlled relapse-prevention
study of 400 adult patients with MDD was conducted. In this long-term study, Lu
AA21004 (5 and 10 mg/day) was effective in preventing relapse in patients with
MDD and was well tolerated as short-term and as maintenance treatment. The
proportion of patients who relapsed was lower in the Lu AA21004 group (13%,
n=27) than in the placebo group (26%, n=50). The most common adverse events
during the combined open-label and double-blind treatment phases were nausea,
headache and nasopharyngitis (i.e. common cold).
Abstract: Efficacy and tolerability of Lu AA21004 5 mg in a 6-week treatment of
adults with major depressive disorder
Jain, R., MD, MPH; Mahableshwarkar, A.R., MD; Jacobsen, P., MS; Chen, Y., PhD;
Thase, M.E., MD
The results of a phase III, multicenter, randomized, double-blind, placebo-
controlled study of Lu AA21004 in 600 adult patients with MDD were also
presented at the APA annual meeting. In this study Lu AA21004 5 mg did not
differ significantly from placebo in the primary analysis of HAM-D24 total
scores or secondary analyses. The most common treatment emergent adverse events
(i.e., those reported by at least 10 percent of Lu AA21004 patients, and twice
the rate of placebo) included headache, nausea and diarrhea.
Abstract: A randomised, double-blind, placebo controlled, duloxetine-referenced,
fixed-dose study of three dosages of Lu AA21004 in acute treatment of major
depressive disorder
David S. Baldwin, D.M., Henrik Loft, M.Sc., Marianne Dragheim, M.D.
The objective of this study in 766 adult patients with MDD was to evaluate the
efficacy, safety, and tolerability of 2.5 mg, 5 mg, 10 mg Lu AA21004 versus
placebo using 60 mg duloxetine as active reference. None of the active treatment
groups reached statistically significant separation from placebo on the primary
analysis of change from baseline in Montgomery-Åsberg Depression Rating Scale
(MADRS) total score at week 8. Findings on secondary efficacy measures were
supportive of likely efficacy for 5 mg and 10 mg of Lu AA21004. The most common
treatment emergent adverse events (i.e., those reported by at least 10 percent
of Lu AA21004 patients, and twice the rate of placebo) were nausea, headache and
dizziness.
Separate presentations at the 2011 APA meeting included results from pre-
clinical research to investigate the pharmacology of Lu AA21004:
* Pharmacological in vitro profile of Lu AA21004, a novel multimodal drug for
the treatment of mood disorders
* Steady-state levels of the antidepressant Lu AA21004 in plasma, brain and
CSF, and 5-HT target engagement in the rat
* Effects of sub-chronic treatment with the multimodal antidepressant Lu
AA21004 on rat brain neurochemistry
About Lu AA21004
Lu AA21004 is an investigational multimodal anti-depressant that is thought to
work through a combination of two pharmacological modes of action: reuptake
inhibition and receptor activity. It functions as a 5-HT(3) and 5-HT(7) receptor
antagonist, 5-HT(1A) receptor agonist, 5-HT(1B) receptor partial agonist and
inhibitor of the 5-HT transporter. In preclinical studies it has been
demonstrated that Lu AA21004 enhances levels of the neurotransmitters serotonin,
noradrenaline, dopamine, acetylcholine and histamine in specific areas of the
brain. All of the activities are considered to be of clinical relevance and
potentially involved in the mechanism of action of Lu AA21004.
About major depression
Major depressive disorder (MDD) - commonly referred to as major depression - is
a highly prevalent, serious and debilitating medical condition. The disease can
be described as a complex syndrome of emotional, psychological and somatic
symptoms.
The significant clinical heterogeneity of the disease is frequently cited as a
reason for the limited efficacy of currently available antidepressants. While
several treatments are available, less than 50% of patients remain symptomatic
following first-line treatment, and a third fail to achieve full resolution of
depressive symptoms after four established treatments.
MDD is the leading cause of years lost due to disability in the world, and
projected to be the biggest contributor to the worldwide burden of disease by
2030. It is estimated that between a quarter and a third of the population will
develop at least one episode of major depression during life-time and of these
as many as two thirds will have recurrent episodes, and one third will develop a
chronic condition.
Takeda and Lundbeck alliance
In September 2007, Lundbeck and Takeda Pharmaceutical Company Limited formed a
strategic alliance for the exclusive co-development and co-commercialization in
the United States and Japan of several compounds in Lundbeck's pipeline for the
treatment of mood and anxiety disorders. The partnership initially focuses on
co-development and co-commercialization of the two most advanced compounds in
Lundbeck's pipeline for mood and anxiety disorders, Lu AA21004 and Lu AA24530.
Once approved, the companies will co-promote the products in the United States
and Japan.
Financial guidance
The content of this release will have no influence on the Lundbeck Group's
financial guidance for 2011 which was provided on 24 February 2011 in connection
with the release of the financial results for 2010.
Lundbeck contacts
Investors: Media:
Palle Holm Olesen Mads Kronborg
Chief Specialist, Investor Relations Media Relations Manager
+45 36 43 24 26 +45 36 43 28 51
Magnus Thorstholm Jensen Simon Mehl Augustesen
Investor Relations Officer International Media Specialist
+45 36 43 38 16 +45 36 43 49 80
Jacob Tolstrup
Vice President
+1 847 282 5713
About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical
company highly committed to improving the quality of life for people suffering
from central nervous system (CNS) disorders. For this purpose, Lundbeck is
engaged in the research, development, production, marketing and sale of
pharmaceuticals across the world. The company's products are targeted at
disorders such as depression and anxiety, schizophrenia, insomnia, epilepsy and
Huntington's, Alzheimer's and Parkinson's diseases.
Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark. Today
Lundbeck employs approximately 5,900 people worldwide. Lundbeck is one of the
world's leading pharmaceutical companies working with CNS disorders. In 2010,
the company's revenue was DKK 14.8 billion (approximately EUR 2.0 billion or USD
2.6 billion). For more information, please visit www.lundbeck.com.
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