Lundbeck and Otsuka to Co-Develop a Vaccine, Lu AF20513, Their Third
Collaborative Development Project to Tackle Alzheimer's Disease
*Lu AF20513 is an anti-beta-amlyoid (anti-Aβ) active vaccine concept
expected to enter phase I clinical testing in 2014
*The two companies’ collaboration on Lu AF20513 represents a different
approach from most other drug research to date on Alzheimer’s disease
*Alzheimer's disease affects at least 34 million people worldwide^i. The
cost to society from dementia has been reported as USD ~600 billion per
*Lu AF20513 is the third joint investigational project by the two companies
that seeks to address a dimension of Alzheimer’s disease
VALBY, Denmark & TOKYO -- December 11, 2013
H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today
announced that they will further expand their collaboration to include the
development of Lu AF20513, an investigational vaccine candidate for
Lu AF20513 is an anti-Aβ active vaccine candidate for Alzheimer’s disease
which currently is in preclinical development. It is designed towards an
optimal immunogenic response in the elderly, based on the hypothesis that
cognitive function would be preserved through the early inhibition of amlyoid
The agreement covers the development of Lu AF20513 through clinical phase I.
Following completion of the clinical phase I study the parties have an option
to enter into a co-commercialization and co-development agreement under terms
to be agreed upon.
Lundbeck will receive from Otsuka an initial payment of EUR 4 million
(approximately USD 5.4 million) upon signing and Lundbeck will finance the
phase I development costs. Additional specific financial terms of the
agreement remain undisclosed.
It is expected that the phase I study will be initiated during 2014.
In addition to the vaccine candidate Lu AF20513, the two companies are
pursuing development of two other potential treatments for different symptoms
that can occur in patients with Alzheimer’s disease -- Lu AE58054, a 5HT
receptor antagonist for the treatment of cognitive impairment associated with
Alzheimer’s and brexpiprazole, an investigational agent with high affinity to
multiple serotonin, dopamine and norepinephrine receptors for the treatment of
agitation in patients with Alzheimer’s. Both projects are currently in phase
III clinical trials.
These research programs illustrate the depth and breadth of experience and
resources the two firms can draw on in neuroscience research and development.
The two companies’ collective revenues in the central nervous system (CNS)
area rank the alliance number one in this field^iii.
About Lu AF20513
Lu AF20513 is an active vaccine inducing high affinity polyclonal antibodies
that targets beta-amyloid (Aβ), a protein that can exert toxic effects in the
brain and is believed to play a central role in the pathology of Alzheimer’s
disease. Lu AF20513 is expected to provide an enhanced and heterogeneous
immunogenic response towards Aβ peptides in comparison to monoclonal antibody
About Alzheimer's disease
Alzheimer's disease is a progressive brain disorder in which the brain
gradually degenerates. It most frequently occurs in people above 65 years of
age. People with Alzheimer's disease develop distressing changes in memory,
thought, function and behaviour, which worsen over time. These changes
increasingly impact the person's daily life and reduce their independence
until ultimately these patients are entirely dependent on others^iv.
Alzheimer's disease also has an enormous impact on the patient's caregiver.
Most caregivers are close relatives who provide care at home - a demanding and
exhausting role that represents a significant emotional and physical burden^v.
Worldwide, it is estimated that about 44 million people have dementia. With
the shift towards an increasingly elderly population, it is predicted that the
number of people affected by dementia will almost double every 20 years, and
by the year 2050, 135 million people will have the condition^ii. Alzheimer's
disease is the most common cause of dementia, accounting for 50 to 80% of
The worldwide costs of dementia, estimated at around USD 600 billion in 2010,
amount to more than 1% of the global gross domestic product (GDP).
H. Lundbeck is a global pharmaceutical company specialized in brain diseases.
For more than 50 years, we have been at the forefront of research within
neuroscience. Our development and distribution of pioneering treatments
continues to make a difference to people living with brain diseases. Our key
areas of focus are alcohol dependence, Alzheimer’s disease,
depression/anxiety, epilepsy, Huntington’s disease, Parkinson’s disease,
schizophrenia and stroke.
Our 5,800 employees in 57 countries are engaged in the entire value chain
throughout research, development, production, marketing and sales, and are
committed to improving the quality of life of people living with brain
diseases. Our pipeline consists of several late-stage development programs and
our products are available in more 100 countries. We have research centers in
China, Denmark and the United States, and production facilities in China,
Denmark, France, Italy and Mexico. Lundbeck generated revenue of approximately
DKK 15 billion in 2012 (EUR 2 billion; USD 2.6 billion).
Lundbeck’s shares are listed on the stock exchange in Copenhagen under the
symbol ”LUN”. Lundbeck has a sponsored Level 1 ADR program listed in the US
(OTC) under the symbol ”HLUYY”. For additional information, we encourage you
to visit our corporate site www.lundbeck.com.
About Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the
corporate philosophy: 'Otsuka-people creating new products for better health
worldwide.' Otsuka researches, develops, manufactures and markets innovative
and original products, with a focus on pharmaceutical products for the
treatment of diseases and nutraceutical products for the maintenance of
In pharmaceuticals, Otsuka is a leading firm in the challenging area of mental
health and also has research programs for several under-addressed diseases
including tuberculosis, a significant global public health issue. These
commitments illustrate more powerfully than words how Otsuka is a “big
venture” company at heart, applying a youthful spirit of creativity in
everything it does.
Otsuka is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding
company for the Otsuka Group. The chairman Akihiko Otsuka is the third
generation of Otsuka family members to lead the business, whose origins date
from 1921. The Otsuka Group employs approximately 42,000 people globally and
its products are available in more than 80 countries worldwide. Consolidated
sales were approximately USD 13 billion for fiscal year 2012
(4/1/2012-3/31/2013). Otsuka Pharmaceutical invites you to visit its global
website at https://www.otsuka.co.jp/en/
Barnes DE, Yaffe K. The projected effect of risk factor reduction
^i on Alzheimer's disease prevalence. Lancet Neurology. 2011;
^ii Alzheimer’s Disease International. The global impact of dementia
^iii Based on IMS data (MATQ2.2013)
Georges J, Jansen S, Jackson J, et al. Alzheimer's disease in real
^iv life - the dementia carer's survey. International Journal Geriatric
Psychiatry. 2008; 23 (5): 546-551.
Mohamed S et al. Caregiver burden in Alzheimer disease: cross
^v sectional and longitudinal patient correlates. 2010; (10):917-27. .
Data from Clinical antipsychotic trials of intervention
effectiveness (CATIE)-AD study
Alzheimer's Association. “Alzheimer's changes the whole brain”
^vi Brain Tour. 2011. Document accessible at:
Photos/Multimedia Gallery Available:
H. Lundbeck A/S Contacts
H. Lundbeck A/S
Palle Holm Olesen, +45 36 43 24 26
Chief Specialist, Head of Investor Relations
H. Lundbeck A/S
Mads Kronborg, +45 36 43 30 30
Media Relations Manager
Otsuka Pharmaceutical Contacts
Media: North America
Otsuka America Pharmaceutical, Inc.
Kevin Wiggins, +1 609-524-6879
Otsuka Pharmaceutical, Europe Ltd.
Alison Ross, +44 7768 337128
Media: Japan /Asia
Otsuka Pharmaceutical Co, Ltd.
Jeffrey Gilbert, +81 3 6361 7379 / +81 80 8728 6039
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