Update on Lu AA21004 clinical development programme in major depressive disorder (MDD)



H. Lundbeck A/S (Lundbeck) and Takeda Pharmaceutical Company Limited
(Takeda) today jointly announced headline results from the first
three clinical trials in the phase III development programme with Lu
AA21004 in major depressive disorder (MDD). Previously reported
clinical phase II data showed equal efficacy with the 5 and 10 mg
doses.

In the recently completed phase III clinical trials, Lu AA21004 was
tested in doses of 2.5, 5 and 10 mg. Results from two studies, which
included the lower dosages, 2.5 and 5 mg, did not reach significance
across studies when compared with placebo.

A third trial demonstrated mixed results, with the 2.5 mg dose not
reaching statistical significance compared to placebo, and the 5 and
10 mg doses showing separation from placebo, although not in all
analyses. These results also suggest that a higher dose may be more
efficacious.

In all of these trials, Lu AA21004 was well tolerated and confirmed
the previously observed favourable safety profile.

As a result, the most appropriate dose of Lu AA21004 needs to be
established. It is anticipated that this work will postpone
submission of the new drug application (NDA) in the US with
approximately 18-24 months. Lundbeck and Takeda will continue to work
with the U.S. Food and Drug Administration (FDA) and other regulatory
agencies on the clinical development program and submission plans.

Lu AA21004 is also in phase III development for generalised anxiety
disorder (GAD).

About depression
Depression is a very common, debilitating illness affecting around
121 million people worldwide. Depression is not at all recognised by
society as the serious disorder it actually is. The symptoms of
depression can be chronic or recurrent, and impact patients both
mentally and physically. Depression has a significant impact on
patient quality of life and imposes a considerable burden on society,
yet it is still under-recognised and undertreated with less than 25
percent of those affected having access to effective treatment.

Symptoms include feelings of sadness, anxiety, loss of interest in
activities, decreased energy, impaired sleep, impaired concentration,
hopelessness, guilt, persistent physical symptoms such as pain and
digestive disorders, and in more severe cases, suicidal thoughts and
suicide attempts.

Takeda and Lundbeck alliance
In September 2007, H. Lundbeck A/S 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.

Conference call
Today at 10.00 am (CET), Lundbeck will be hosting a conference call.
You can listen to the conference on the Group's website
www.lundbeck.com under the section "Investors - Presentations".

Lundbeck contacts


Investors:                   Media:

Jacob Tolstrup, Lundbeck     Mads Kronborg
Director, IR & Communication Media Relations
+45 36 43 30 79              +45 36 43 28 51

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


Takeda contact


Seizo Masuda, Takeda Pharmaceutical Company, Ltd.
Coordinator, Corporate Communications Dept.
+81 3 3278 2037



About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international
pharmaceutical company highly committed to improve the quality of
life for people suffering from central nervous system (CNS)
disorders. For this purpose Lundbeck is engaged in the research and
development, production, marketing and sale of pharmaceuticals across
the world, targeted at disorders like depression and anxiety,
schizophrenia, insomnia, Huntington's, Alzheimer's and Parkinson's
diseases.

Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark,
and employs today over 5,500 people worldwide. Lundbeck is one of the
world's leading pharmaceutical companies working with CNS disorders.
In 2008, the company's revenue was DKK 11.3 billion (approximately
EUR 1.5 billion or USD 2.2 billion). For more information, please
visit www.lundbeck.com.

About Takeda
Located in Osaka, Japan, Takeda (TSE:4502) 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 striving toward better health for
individuals and progress in medicine by developing superior
pharmaceutical products. Additional information about Takeda is
available through its corporate website, www.takeda.com.

Attachments

Release no 375.pdf