Whither Eli Lilly’s Go-it-Alone Strategy in Wake of Alzheimer Drug Failure?
After years of anticipation and growing skepticism, Eli Lilly (LLY) this morning disclosed that an Alzheimer’s medication failed to meet the primary endpoints, both cognitive and functional, in a pair of Phase III double-blind, placebo-controlled trials in patients with mild-to-moderate Alzheimer’s disease. Although disappointing, the outcome was actually mixed, but may still renew questions about the future for Lilly as it grapples with its commitment to Alzheimer’s research.
For the past few years, Lilly ceo John Lechleiter has repeatedly acknowledged that the drugmaker was placing a big bet on Alzheimer’s compounds under the guise that the high-risk, high-reward scenario might help compensate for the crushing loss of revenue as several big-selling medicines lost patent protection and began facing generic competition. Now, though, that theory may be tested and perhaps revive calls for him to rethink his reluctance to mergers.
Revenue growth, in the face of patent expirations on major drugs, is an issue for the entire pharma industry.
Lilly, however, noted that a pre-specified secondary analysis of pooled data showed statistically significant slowing of cognitive decline in patients with mild-to-moderate disease who were treated with its solanezumab compound. And pre-specified secondary subgroup analyses of pooled data across both studies showed a statistically significant slowing of cognitive decline in patients with mild disease, but not in those with moderate disease.
“We recognize that the solanezumab studies did not meet their primary endpoints, but we are encouraged by the pooled data that appear to show a slowing of cognitive decline,” Lechleiter says in a statement. “We intend to discuss these data with regulatory authorities to gain their insights on potential next steps.” And Lilly exec vp for science and technology Jan Lundberg says the drugmaker remains “committed” to find meds that alter the “pathology” of Alzheimer’s.Pharmalot.