Lundbeck and Otsuka Further Expand Alliance and Enter into Collaboration for
the Development and Commercialization of Lu AE58054 in Development for
*Clinical phase II data will be presented at the AAIC in Boston in July
*A phase III program of more than 2,500 patients will commence during 2013
*Lundbeck receives from Otsuka USD 150 million upon signing of the deal
*Within the two companies' global agreement this is the first of the
projects that will ultimately involve co-development and co-promotion of
three Lundbeck drug candidates
Alzheimer’s Association International Conference 2013
TOKYO & COPENHAGEN, Denmark -- March 26, 2013
H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today
announced a license and development agreement for Lu AE58054, a selective
5HT receptor antagonist currently in development for the treatment of
Alzheimer's disease. Under the terms of the agreement, Lundbeck will grant
Otsuka co-development and co-commercialization rights to Lu AE58054 in the
U.S., Canada, East Asia including Japan, major European countries and Nordic
Under the terms of the agreement, Lundbeck will receive from Otsuka an initial
payment of USD 150 million (approximately DKK 855 million) upon signing. Both
companies will share the sales, development, and commercialization costs based
on the agreement. Lundbeck is also entitled to up to USD 675 million
(approximately DKK 3.9 billion) in regulatory and sales milestones. Additional
specific financial terms of the agreement remain undisclosed.
Taro Iwamoto, President and Representative Director of Otsuka Pharmaceutical
Co., Ltd., noted with respect to Lu AE58054 "The global collaboration between
Otsuka and Lundbeck continues to grow stronger with the addition of Lu
AE58054. Not only does the product further enhance the synergy between the
companies as we work together to bring to the market solutions for better
health, Lu AE58054 is a potentially promising development in a very difficult
Ulf Wiinberg, President & Chief Executive Officer of Lundbeck commented "There
is a serious, global, unmet medical need regarding treatments for Alzheimer's
disease in aging populations. Together, Otsuka and Lundbeck with their
development capabilities, commercial experience and geographical reach will
provide a solid foundation in the development of Lu AE58054."
The pivotal clinical program with Lu AE58054 is planned to be initiated later
in 2013. The global program will consist of several studies and include more
than 2,500 patients. The first phase III study will enroll patients with
mild-to-moderate Alzheimer's disease. Lu AE58054 will be tested as adjunct
treatment to donepezil. Subsequent studies are expected to be initiated
towards the end of 2013.
In May 2012, it was announced that Lu AE58054 had met its primary endpoint in
a fixed dose, randomized, placebo-controlled, 24-week clinical study in 278
patients. The study was conducted in patients suffering from moderate
Alzheimer's disease, with Lu AE58054 administered as an add-on to donepezil, a
commonly used acetylcholinesterase inhibitor^i. The clinical data from the
phase II study is planned to be presented at the annual Alzheimer's
Association International Conference (AAIC) in Boston on 13-18 July 2013.
About Lu AE58054^i
Lu AE58054 is a selective 5-HT-receptor antagonist. The 5-HT-receptor is
primarily found in areas of the brain involved in cognition. A number of early
trials have demonstrated that a 5-HT-receptor antagonist could offer
potential benefits in the treatment of disorders such as Alzheimer's disease
and in December 2009 Lundbeck initiated the above described 24 week clinical
phase II trial with Lu AE58054 as augmentation therapy in Alzheimer's disease.
About Alzheimer's disease
Alzheimer's disease is a progressive brain disorder, in which the brain
gradually degenerates. It most frequently occurs in people aged above 65-70
years. People with Alzheimer's disease develop distressing changes in memory,
thought, function and behavior, which worsen over time. These changes
increasingly impact upon the person's daily life, reducing their independence,
until ultimately they are entirely dependent on others.
Alzheimer's disease also has an enormous impact on the patient's caregiver.
Most caregivers are close relatives who provide care in the home - a demanding
and exhausting role that represents an emotional and physical burden^ii.
Alzheimer's disease is associated with damages and death of brain cells,
leading to significant brain shrinkage and neurotransmitter imbalances. As the
brain cells degenerate, characteristic waste accumulates in the brain, known
as 'plaques' and 'tangles'.
Worldwide, 36 million people have dementia. Perhaps as many as 28 million of
the world's 36 million people with dementia have yet to receive a diagnosis
and, therefore, do not have access to treatment, information and care. Every
year, an estimated 4.6 million new cases are identified^iii. 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, 115 million people will have the condition^iv.
Alzheimer's disease is the most common cause of dementia, accounting for
50-70% of cases^v.
The worldwide costs of dementia (USD 604 billion in 2010) amount to more than
1% of gross domestic product (GDP).
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. We are a "big venture" company at heart, applying a youthful
spirit of creativity in everything we do.
In pharmaceuticals, Otsuka is a leading firm in the challenging area of
psychiatric disorders and our drug ABILIFY^® (aripiprazole) recently became
the number-one selling drug in the U.S^vi. Tuberculosis, a global public
health issue, is another research area that we have been active in for several
decades. These commitments illustrate more powerfully than words how we are a
"big venture" company at heart, applying a youthful spirit of creativity in
everything we do.
Otsuka is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding
company for the Otsuka Group. Our chairman Akihiko Otsuka is the third
generation of Otsuka family members to lead the business, whose origins date
from 1921. The Otsuka Group has business operations in 25 countries and
regions around the world, with consolidated sales of approximately USD 14.7
billion for fiscal year 2011 (4/1/2011-3/31/2012.) We welcome you to visit our
global website at https://www.otsuka.co.jp/en/.
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company
highly committed to improving the quality of life of people living with brain
diseases. For this purpose, Lundbeck is engaged in the entire value chain
throughout research, development, production, marketing and sales of
pharmaceuticals across the world. The company's products are targeted at
disorders such as depression and anxiety, psychotic disorders, epilepsy,
Huntington's, Alzheimer's and Parkinson's diseases. Lundbeck's pipeline
consists of several mid- to late- stage development programs.
Lundbeck employs more than 5,800 people worldwide, 2,000 of whom are based in
Denmark. We have employees in 57 countries, and our products are registered in
more than 100 countries. We have research centers in Denmark, China and the
United States and production facilities in Italy, France, Mexico, China and
Denmark. Lundbeck generated revenue of approximately DKK 15 billion in 2012.
For additional information, we encourage you to visit our corporate site
^i H. Lundbeck A/S. (May 2012). Lundbeck's Lu AE58054 meets primary endpoint
in large placebo-controlled clinical proof of concept study in people with
Alzheimer's disease [press release]. Available at
^ii Georges J, Jansen S, Jackson J, et al. Alzheimer's disease in real life -
the dementia carer's survey. Int J Geriatr Psychiatry 2008; 23 (5): 546-551.
^iii Ferri CP, Prince M, Brayne C, et al. Global prevalence of dementia: a
Delphi consensus study. Lancet 2005; 366 (9503): 2112-2117.
^iv Alzheimer Disease International. World Alzheimer Report 2011. The benefits
of early diagnosis and intervention. Published by Alzheimer's Disease
International (ADI), September 2011.
^v Alzheimer's Association. Basics of Alzheimer's disease: what it is and what
you can do. 2010.
^vi ABILIFY sales rank in the overall U.S. market based on IMS data for the
fourth quarter of 2012
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Otsuka Pharmaceutical contacts
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Media in Japan/Asia:
Jeffrey Gilbert, +81-80-8728-6039 (cell)
Public Relations Dept.
Media in Europe:
Alison Ross, +44-7768337128 (cell)
Head of Communications - Europe
Takuma Kimura, +81-3-6361-7411
Mads Kronborg, +45-36-43-28-51
Media Relations Manager
Simon Mehl Augustesen, +45-36-43-49-80
International Media Specialist
Palle Holm Olesen, +45-36-43-24-26
Chief Specialist, Head of Investor Relations
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