Start up of clinical phase III study with Lu AA21004 in Japan
* The clinical phase III development programme for Lu AA21004 now startet
in Japan
* Approximately 360 patients with MDD is expected to be enrolled
* The study is expected to be concluded in about 1.5 years
H. Lundbeck A/S (Lundbeck) and Takeda Pharmaceutical Company Limited (Takeda)
today announced the initiation of a phase III clinical trial in Japan for Lu
AA21004 in patients with major depressive disorder (MDD).
This randomized, double-blind and multi-center phase III clinical trial is
expected to enroll approximately 360 patients with MDD and will evaluate the
efficacy and safety of Lu AA21004 (5 and 10 mg) compared to placebo. Primary
endpoint is change of MADRS[1] total score from baseline after eight weeks.
Lu AA21004 is a structurally novel compound that is different from currently
available antidepressants. Data from clinical trials conducted outside Japan
have shown encouraging results for the potential efficacy and the tolerability
profile of Lu AA21004. In addition to the Japanese study, the ongoing clinical
trial programme includes four ongoing short-term studies and two long-term
safety studies.
Lundbeck and Takeda will continuously work in collaboration to develop Lu
AA21004 in order to provide the drug as soon as possible as a novel treatment
with patients suffering from depression.
About Lu AA21004
Lu AA21004 is an investigational multimodal antidepressant 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, around 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 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.
Takeda contact
Corporate Communications Dept.
+81 3 3278 2037
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 Takeda
Located in Osaka, Japan, Takeda is a research-based global company with its main
focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one
of the global leaders of the industry, Takeda is committed to strive towards
better health for patients worldwide through leading innovation in medicine.
Additional information about Takeda is available through its corporate website,
www.takeda.com
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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[1] *MADRS (Montgomery-Asberg Depression Rating Scale): A ten-item diagnostic
questionnaire which psychiatrists use to measure the severity of depressive
episodes. It is picked out from Comprehensive Psychopathological Rating Scale
(CPRS), developed in Sweden.
[HUG#1513704]
