Eli Lilly & Co. (NYSE: LLY) is confirming prior news showing that late-stage trial data analysis showed the the primary endpoints in cognitive and functional were not met in the two Phase 3, double-blind, placebo-controlled solanezumab EXPEDITION trials. While this sounds bad on the surface, the study in patients with mild-to-moderate Alzheimer’s disease may still allow for approvals.
Lilly’s secondary analysis of pooled data in patients with mild Alzheimer’s disease showed that a statistically significant slowing of cognitive decline was shown with a 34% reduction in decline. It has been previously indicated that only 35% reduction might be needed for the approval process to continue.
Today’s data is similar to top-line results originally reported on August 24, 2012 and the company said that the next steps for solanezumab will be determined after discussions with regulators.
Lilly shares are up more than 2% at $49.34 on the news to a new 52-week high. With a market cap of $54 billion now, it is important to realize that the market value of this has been $1 billion in value on this news alone.
With no known cure and millions of patients suffering from Alzheimer’s and related cognitive diseases, the prize is potentially billions and billions of dollars to companies which can offer any assistance at all in this devastating disease.
JON C. OGG