AI assistant
H. Lundbeck A — Earnings Release 2011
May 29, 2012
Preview isn't available for this file type.
Download source file-- Patients receiving the investigational compound Lu AE58054 achieved
statistically significant improvement in cognitive performance when added
to donepezil
-- In the clinical study Lu AE58054 was well-tolerated in combination with
donepezil
-- The pivotal clinical programme is in planning
-- Alzheimer’s disease affects over 26 million people worldwide. The cost to
society has been reported as USD 600 billion per annum
H. Lundbeck A/S (Lundbeck) today announced that Lu AE58054 has met its primary
endpoint in a fixed dose, randomized, placebo-controlled clinical study in 278
patients suffering from Alzheimer’s disease.
The investigational compound, Lu AE58054 is a novel, selective 5HT6 receptor
antagonist with a different mechanism of action than currently available
Alzheimer’s medications.
Augmentation therapy with Lu AE58054 (plus10mg/day donepezil) at the selected
dose resulted in statistically significant improvement in cognition, as
measured by the ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive
sub-scale) over a 24 week treatment period versus placebo (plus10mg/day
donepezil). Secondary endpoints, including measures of global status and
activities of daily living also showed positive trends with the addition of Lu
AE58054, compared with patients who only received donepezil.
Treatment with Lu AE58054 in this study was well tolerated.
"These results are very encouraging, and we are now evaluating how to best
proceed with the development of Lu AE58054," says Executive Vice President
Anders Gersel Pedersen, Head of Research & Development at Lundbeck, and
continues: "We believe that there is a strong need for better treatments for
patients with Alzheimer's disease, and Lundbeck sees Lu AE58054 as a potential
new treatment option for this devastating disease."
The study was conducted in 278 patients suffering from moderate Alzheimer’s
disease, and Lu AE58054 was administered as add-on to donepezil, a commonly
used acetylcholinesterase inhibitor for a period of 24 weeks. In the study, Lu
AE58054 as adjunctive treatment to donepezil was compared with placebo plus
donepezil. Lu AE58054 (plus donepezil) demonstrated significant improvements in
cognitive function in Alzheimer’s disease compared to placebo (plus donepezil),
as assessed by ADAS-cog. Lu AE58054 was considered overall to be well tolerated
at the selected dose.
The study was conducted in selected European countries as well as Canada and
Australia.
Lundbeck is now evaluating the future development strategy of Lu AE58054 with
the intention to initiate a major pivotal clinical programme potentially
including development and commercial partnerships.
Full data from this study will be made available through scientific disclosure
at upcoming medical congresses and in scientific publications.
Financial guidance
The content of this release will have no influence on the Lundbeck Group's
financial guidance for 2012 which was provided on 8 February 2012 in connection
with the release of the financial results for 2011.
About Lu AE58054
Lu AE58054 is a potent and selective 5-HT6-receptor antagonist. The
5-HT6-receptor is primarily found in areas of the brain involved in cognition.
A number of early trials have demonstrated that a 5-HT6-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 behaviour, 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[i].
Alzheimer’s disease damages and kills 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[ii]. 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[iii].
Alzheimer’s disease is the most common cause of dementia, accounting for 50–70%
of cases[iv].
The worldwide costs of dementia (USD 604 billion in 2010) amount to more than
1% of gross domestic product (GDP).
Lundbeck contacts
Investors: Media:
Palle Holm Olesen Mads Kronborg
Chief Specialist, Head of Investor Relations Media Relations Manager
[email protected] [email protected]
+45 36 43 24 26 +45 36 43 28 51
Magnus Thorstholm Jensen Simon Mehl Augustesen
Investor Relations Officer International Media Specialist
[email protected] [email protected]
+45 36 43 38 16 +45 36 43 49 80
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 brain 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, psychotic disorders, 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 6,000 people worldwide. Lundbeck is one of the
world’s leading pharmaceutical companies working with brain disorders. In 2011,
the company's revenue was DKK 16.0 billion (approximately EUR 2.1 billion or
USD 3.0 billion). For more information, please visit www.lundbeck.com.
Safe Harbor/Forward-Looking Statements
The above information contains forward-looking statements that provide our
expectations or forecasts of future events such as new product introductions,
product approvals and financial performance.
Such forward-looking statements are subject to risks, uncertainties and
inaccurate assumptions. This may cause actual results to differ materially from
expectations and it may cause any or all of our forward-looking statements here
or in other publications to be wrong. Factors that may affect future results
include interest rate and currency exchange rate fluctuations, delay or failure
of development projects, production problems, unexpected contract breaches or
terminations, government-mandated or market-driven price decreases for
Lundbeck's products, introduction of competing products, Lundbeck's ability to
successfully market both new and existing products, exposure to product
liability and other lawsuits, changes in reimbursement rules and governmental
laws and related interpretation thereof, and unexpected growth in costs and
expenses.
Certain assumptions made by Lundbeck are required by Danish Securities Law for
full disclosure of material corporate information. Some assumptions, including
assumptions relating to sales associated with product that is prescribed for
unapproved uses, are made taking into account past performances of other
similar drugs for similar disease states or past performance of the same drug
in other regions where the product is currently marketed. It is important to
note that although physicians may, as part of their freedom to practice
medicine in the US, prescribe approved drugs for any use they deem appropriate,
including unapproved uses, at Lundbeck, promotion of unapproved uses is
strictly prohibited.
[i]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.
[ii] Ferri CP, Prince M, Brayne C, et al. Global prevalence of dementia: a
Delphi consensus study. Lancet 2005; 366 (9503): 2112–2117.
[iii] Alzheimer Disease International. World Alzheimer Report 2011. The
benefits of early diagnosis and intervention. Published by Alzheimer’s Disease
International (ADI), September 2011.
[iv] Alzheimer’s Association. Basics of Alzheimer’s disease: what it is and
what you can do. 2010.
http://www.alz.org/national/documents/brochure_basicsofalz_low.pdf. Accessed
30/09/11.