Mixed results with Eli Lilly Alzheimer's drug solanezumab, but investors pleased

US pharma major Eli Lilly (NYSE: LLY) yesterday reported detailed results from two Phase III studies for solanezumab, EXPEDITION1 and EXPEDITION2 following a presentation of the independent analyses by the Alzheimer’s Disease Cooperative Study showing that, while solanezumab did not meet its primary endpoints, in Lilly's pre-specified secondary analysis of pooled data in patients with mild Alzheimer's disease, a statistically-significant slowing of cognitive decline was shown; this finding represented a 34% reduction in decline.

In addition, the secondary analysis of the pooled data in patients with mild Alzheimer's disease showed a 17% reduction of functional decline as measured by the Alzheimer's Disease Cooperative Study (ADCS)-ADL. However, the treatment difference was not statistically significant compared with placebo (p=.057). Next steps for solanezumab will be determined after discussions with regulators, said Lilly. Initial data unveiled in August created doubts about whether the drug could be approved by the US Food and Drug Administration without large new studies (The Pharma Letter August 28).

If successful, could generate sales of $5-$10 billion