Lundbeck/Otsuka Alzheimer’s drug improves cognition
pharmafile | July 17, 2013 | News story | Research and Development, Sales and Marketing | Alzheimer's, Lundbeck, Otsuka
Lundbeck and partner Otsuka have posted positive Phase II results for their experimental Alzheimer’s drug.
The latest data show statistically significant improvement for Lu AE58054 as an add-on to Pfizer’s ageing Alzheimer’s drug Aricept (donepezil), compared to using Aricept alone, on improving cognitive symptoms of the disease.
Lundbeck partnered with Japanese firm Otsuka in March to co-develop the drug, as the Danish firm looks to offset falling sales of drugs that are losing patent protection.
The data were showed at the Alzheimer’s Association International Conference 2013 (AAIC 2013) in Boston this week.
Lundbeck estimates that its drug, if approved, could have the potential to generate US sales of more than $1 billion per year.
Executive VP Anders Gersel Pedersen, head of R&D at Lundbeck, said: “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.”
He added: “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 Carson, president and chief executive of Otsuka pharmaceutical development and commercialisation, said: “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.”
Both firms said in a statement that they intend to start a Phase III clinical programme for the drug in about 3,000 patients before the end of the year.
The largest development efforts to date on investigational drugs for Alzheimer’s have focused on reducing amyloid plaque formation or excessive phosphorylation of tau proteins.
But Otsuka and Lundbeck’s drug, which blocks 5HT6 receptors, represents an alternative approach.
Around 36 million people worldwide are estimated to have dementia, with the number expected to almost double every 20 years, but there are no ‘breakthrough’ drugs on the market to help battle the disease.
Any pharma firm which markets a medicine that is able to significantly slow down the disease – or even reverse it – would likely see that treatment become one of the biggest selling of all time, given the extent of Alzheimer’s in an ageing global population.
Ben Adams
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