Lundbeck's Innovative Alzheimer's Drug Met Primary Cognition Endpoint

Patients receiving investigational compound Lu AE58054 achieved statistically significant improvement in cognitive performance when added to donepezil

Toronto, ON and Montreal, QC (Marketwire) - Lundbeck Canada announced that its investigational Alzheimer's drug Lu AE58054 met its primary cognition endpoint in patients with Alzheimer's disease. This compound is a novel, selective 5-HT₆receptor antagonist with a different mechanism of action than currently available Alzheimer's medications.

The large, phase 2, proof-of-concept study was conducted in 278 patients in Canada, Europe, and Australia with either Lu AE58054 (plus 10mg/day donepezil) or placebo (plus 10mg/day donepezil).

Augmentation therapy with Lu AE58054 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 donepezil monotherapy (10mg/day). 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.

"As our Canadian population ages, effective and safe treatments that can help reduce Alzheimer's symptoms are becoming increasingly crucial," said Dr. Sharon Cohen, behavioural neurologist and Medical Director of Toronto Memory Program. "It is encouraging to see these positive preliminary results and it will be interesting to follow this compound's development."

Lundbeck is now evaluating the future development strategy of Lu AE58054 with the intention to initiate a major pivotal clinical program, potentially including development and commercial partnerships.

"Lundbeck is very pleased with the results," said Jean Proulx, Senior Director, Scientific Affairs at Lundbeck Canada. "We see Lu AE58054 as having a strong potential in Alzheimer's disease, a disease with a huge unmet medical need."

Full data from this study will be made available through scientific disclosure at upcoming medical congresses and in scientific publications.

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 2 trial with Lu AE58054 as augmentation therapy in Alzheimer's disease.

About Alzheimer's disease

Alzheimer's disease is the most common neurodegenerative disorder and most frequent cause of dementia, accounting for 50-70% of cases.¹Alzheimer's disease is a progressive brain disorder in which the brain gradually degenerates. It most frequently occurs in people aged above 65-70 years. In Canada, an estimated 500,000 Canadians, or 1 in 11 people over the age of 65, have Alzheimer's or a related dementia. Within a generation, it is estimated that between 1 and 1.3 million Canadians will have the disease.²

Alzheimer's disease also has an enormous impact on the patient's caregiver. One in five Canadians over the age of 45 is providing unpaid care of some kind to seniors with long-term health problems.³ Family caregivers contribute over $5 billion of unpaid care every year.⁴

About Lundbeck Canada Inc.

Montreal-based Lundbeck Canada is a subsidiary of H. Lundbeck A/S, a leading international research-based pharmaceutical company. Lundbeck has built its reputation as a leader in specialty treatments. For decades, we've concentrated our expertise on helping people everywhere fight CNS disorders such as Alzheimer, depression, anxiety and schizophrenia. Now, we're directing that same focus and energy to oncology. Visit us at www.lundbeck.ca.

¹ 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.

² Rising Tide - The Impact of Dementia on Canadian Society. Alzheimer Society of Canada.

³ Eldercare: What We Know Today. Statistics Canada report, October 20, 2008.

⁴ A profile of Canadian chronic care providers. Fast, J., Niehaus, L., Eales, J., & Keating, N. 2002a.

SOURCE: Lundbeck Canada Inc.