After Eli Lilly’s solanezumab failed to meet its primary endpoint in the EXPEDITION-3 trial, the company now plans to eliminate approximately 485 jobs across the US.
Solanezumab was expected to be the first disease-modifying drug to be launched for Alzheimer’s disease (AD), with a potential to generate multi-billion dollar sales. However, the failure has resulted in the closure of Eli Lilly’s Alzheimer’s unit, which was based in Indianapolis, Indiana. It has also created an urgent need for Eli Lilly to reevaluate its current pipeline assets.
Solanezumab’s failure was a big disappointment in AD research, as the drug had long led the race for the first treatment to reverse or halt AD. EXPEDITION-3 was a 39-center, Phase III trial in 2,100 patients with mild AD, which was initiated despite the fact that 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 the company, as it 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 this and other therapy areas. It already entered a new collaboration with AstraZeneca in December 2016 to co-develop MEDI1814, an antibody selective for amyloid-beta 42. This is currently in Phase I trials.
In January 2017, Eli Lilly announced its plan to acquire 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 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.