After Eli Lilly’s Alzheimer’s disease (AD) drug, solanezumab, failed to meet its primary endpoint in their Phase III trial, the company now intends to cut close to 485 jobs in the US. Initially, it was hoped solanezumab would become the first disease-modifying drug for AD, with the prospect of it generating billions of dollars in sales. Nevertheless, the drug’s failure will force Eli Lilly’s hand in shuttering its US-based Alzheimer’s unit in Indianapolis, IN. It will also necessitate the need for the company to reassess assets currently in the pipeline.
With Solanezumab long having led the way in the race to become the first treatment to reverse or halt AD, the drug’s failure will come as a huge blow for AD research. The Phase III trial, EXPEDITION-3, was a 39-center study treating 2,100 patients with mild AD, which was initiated despite the fact solanezumab had failed two large Phase III trials (EXPEDITION-1 and -2) in 2012. Eli Lilly’s gamble to continue the trial and retest the drug in mild AD patients resulted once again in a disappointment, which will have a serious ramification for Eli Lilly, as the company still has six AD products in its pipeline with a similar mechanism of action: targeting amyloid-beta.
Given the high risk associated with its AD pipeline drugs, Eli Lilly is now looking to strengthen its pipeline in AD and in other therapy areas. It has already entered a new collaboration with AstraZeneca in December 2016 to co-develop MEDI1814, an antibody selective for amyloid-beta 42, which is currently in Phase I trials. Further, in January 2017, Eli Lilly has announced its plan to acquire a migraine biotech, CoLucid, in an effort to grow its pain management portfolio and build its presence in the sector.
Beyond Eli Lilly, solanezumab’s failure was also a significant blow for competing companies that are currently developing drugs that similarly target amyloid-beta. Manufacturers such as Roche, Johnson & Johnson, Biogen, and Merck are also pursuing late-stage studies in drugs aiming to clear amyloid from the brain. Given this serious setback, their successes will now depend on tackling the major unmet need within AD research, namely lack of objective biomarkers. If the cause and effect between amyloid build-up and AD disease progression can be demonstrated using a measurable biomarker, a cure for AD may be within reach. To achieve this, it will be increasingly important for manufacturers to develop drugs and biomarkers alongside each other.
*This article first appeared in GlobalData Expert Insights on Jan. 25, 2017