Biogen lost around 30% of its value after discontinuing a Phase III trial of Alzheimer’s disease candidate aducanumab. The CRO involved will also take a hit in revenues.
Codeveloped with Eisai, aducanumab had been undergoing Phase III clinical trials in patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia.
But the firms took the decision to halt the study this week – along with the EVOLVE Phase 2 safety study and the long-term extension of the PRIME Phase1b study – based on results of a futility analysis conducted by an independent data monitoring committee. The committee indicated the trials were unlikely to meet their primary endpoint upon completion, and the recommendation to stop the trials were not safety related.
“This disappointing news confirms the complexity of treating Alzheimer’s disease and the need to further advance knowledge in neuroscience,” Biogen’s CEO Michel Vounatsos said. “We are incredibly grateful to all the Alzheimer’s disease patients, their families and the investigators who participated in the trials and contributed greatly to this research.”
Following the announcement, Biogen’s stock dropped by 30%, representing a loss of around $18 billion (€16 billion) of its market value.
$150m CRO hit?
The news is likely to have gathered a lot of attention from investors in the contract research organization (CRO), ISI Evercore analyst Ross Muken said in a note.
“While study failures are not uncommon, failures of this prominence garner a lot of attention from CRO investors. Ultimately, while this is a setback for Alzheimer’s research, it is not a major event for the CRO complex. This outcome builds on prior failures in the category and is unlikely to result in a deluge of incremental cancellations,” which he said is “always the fear.”
And, Muken added, Biogen is not the only firm to lose out on the news, as the CRO involved in carrying out the cancelled trials is likely to have lost revenues of – he speculated – between $100 and $150 million.
While the CRO involved has not been divulged, Muken said many believe it to be IQVIA based on Biogen inking a strategic agreement with the CRO (then named Quintiles) in 2014.