Phase II clinical data show statistically significant improvement for Lu AE58054 as add-on to donepezil, versus donepezil alone, on cognitive symptoms of Alzheimer’s disease

Phase II clinical data show statistically significant improvement for Lu AE58054 as add-on to donepezil, versus donepezil alone, on cognitive symptoms of Alzheimer’s diseaseⁱ

• Lundbeck and Otsuka present data at Alzheimer’s Association International Conference 2013
• Lu AE58054 is a selective 5-HT6 receptor antagonist under investigation for the treatment of Alzheimer's diseaseⁱⁱ
• Lundbeck and Otsuka will initiate a phase III clinical program in about 3,000 patients during the second half of 2013
• The two companies’ focus on the 5-HT6 receptor is a different approach from the amyloid and tau hypotheses that have underpinned much of the research to date on Alzheimer’s diseaseiii
• 36 million people worldwide are estimated to have dementia, with the number expected to almost double every 20 years^iv,v

Valby, Denmark and Tokyo, Japan, 16 July 2013 - H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd.  (Otsuka) today announced the presentation of the first clinical data on the investigational drug Lu AE58054 in Alzheimer’s disease at the Alzheimer’s Association International Conference 2013 (AAIC 2013) in Boston.

The phase II clinical study demonstrated that treatment with Lu AE58054 as add-on to donepezil for six months improved cognitive performance in patients with moderate Alzheimer’s diseaseⁱ.

“I am very pleased with the data achieved in this project.  Lu AE58054 potentially represents a new approach to Alzheimer’s disease and a continuation of Lundbeck’s commitment to addressing this complicated disease”, says Executive Vice President Anders Gersel Pedersen, Head of Research & Development at Lundbeck. “It is my hope that the clinical phase III program will confirm results seen from this phase II trial, and demonstrate a positive outcome on this devastating disease”.

William H. Carson, M.D., President and Chief Executive Officer, Otsuka Pharmaceutical Development and Commercialization, Inc., notes that “Our investigation of the 5-HT6 receptor and its role in memory processes and in Alzheimer’s disease is encouraging. We are eager to continue phase III trials with Lundbeck”.