|[December 11, 2013]
Lundbeck and Otsuka to Co-Develop a Vaccine, Lu AF20513, Their Third Collaborative Development Project to Tackle Alzheimer's Disease
VALBY, Denmark & TOKYO --(Business Wire)--
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 Alzheimer's disease.
Lu AF20513 is an anti-Aß 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 beta depositions.
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 5HT6 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
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 fieldiii.
About Lu AF20513
Lu AF20513 is an active vaccine inducing high affinity polyclonal
antibodies that targets beta-amyloid (Aß), 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 Aß peptides in
comparison to monoclonal antibody treatment strategies.
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 othersiv.
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 burdenv.
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 conditionii. Alzheimer's disease is the most common
cause of dementia, accounting for 50 to 80% of these patientsvi.
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 everyday health.
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 on
Alzheimer's disease prevalence. Lancet Neurology. 2011; (9):819-28.
Alzheimer's Disease International. The global impact of dementia
Based on IMS data (MATQ2.2013)
Georges J, Jansen S, Jackson J, et al. Alzheimer's disease in real
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
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"
Brain Tour. 2011. Document accessible at: http://www.alz.org/braintour/alzheimers_changes.asp.
Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20131210006754/en/
[ Back To Technology News's Homepage ]