Lundbeck’s Lu AE58054 meets primary endpoint in large placebo-controlled clinical proof of concept study in people with Alzheimer’s disease

• 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

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.