On Friday Eli Lilly ($LLY) managed to pull off one of the most difficult tricks in drug development: Turning a failed pivotal study into a plus. A number of commentators jumped right over the fact that its Alzheimer's drug solanezumab had failed both primary endpoints in Phase III and landed squarely on the company's secondary analysis, which picked up a positive trend line for improved cognition among patients with a mild, or earlier stage, form of the disease. By the end of the day, Lilly had ridden the positive trend to a 3.4% hike in its stock price.
The news, and Eli Lilly's handling of the data, triggered a firestorm of remarks on Twitter, including some harsh assessments for a Big Pharma company which preferred to highlight its analysis over the endpoints. In Alzheimer's, desperate patients would be happy to see any indication that something, anything, could help address this dread disease. And some analysts who long ago gave up any hope of seeing anything positive come out of the solanezumab program were willing to applaud an unexpected indication of success.
This morning, Bloomberg published its second take on reactions. And some key experts in the field weren't in the least bit reluctant to view Lilly's approach with considerable skepticism.
For Samuel Gandy, director of Mount Sinai Center for Cognitive Health, the mere fact that Lilly turned to a re-analysis amounted to a red flag. "For the layman, this means poking around a dataset in hand, hunting for a result that may be statistically significant but is unlikely to be clinically significant," he told the business wire. "So caveat emptor here."
Mayo's David Knopman had this to say: "I take care of people with Alzheimer's disease who desperately want to see something positive here. For my patients right now, absolutely it won't be available commercially. I don't want them thinking this is something being withheld by a 'nasty' (FDA), or that the scientists are being too cautious. This was a negative study."
This morning on Twitter, clinical trial expert Bernard Munos noted that "LLY has not produced any innovation since 2004. It's an indictment of current and past CEO."
Eli Lilly's hole card here represents patients' hopes for a new drug. It's playing that card because the company desperately needs a blockbuster product, or at least the hope that it can one day deliver one. -- John Carroll, Editor-in-Chief. Follow me on Twitter and LinkedIn.
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