When Biogen disclosed a filing delay for its closely watched Alzheimer’s disease drug candidate aducanumab back in April, analysts were puzzled and pushed for answers. But no matter when the drug makes its way to regulators, controversy will follow, J.P. Morgan analysts wrote in a recent note, pointing to results from a survey of experts.
Among 30 Alzheimer’s doctors who are “very familiar” with aducanumab's data—20 academic doctors and 10 community docs—most said the drug should not be approved, the analysts wrote. Even still, many of the doctors will prescribe the drug if it is, the firm's expert survey found.
The survey results “pretty clearly” outline “why the ultimate regulatory fate of [aducanumab] stands to be controversial,” J.P. Morgan analyst Cory Kasimov wrote in a note to clients.
An overwhelming majority of docs surveyed—94%— see the drug as at least “somewhat tolerable” for patients, according to the note. But the experts are split on whether the phase 3 data that will support Biogen’s FDA application are “clinically meaningful.”
The doctors treat about 7,000 Alzheimer's patients each year, and the group said they would prescribe aducanumab for about 20% of patients at launch, growing to about 40% after two years, Kasimov wrote.
“Although it is difficult to take these utilization rates at face value, our survey results imply that there will be strong initial demand for aducanumab, if approved,” Kasimov wrote.
After teaming up on aducanumab in 2017, Biogen and its partner Eisai in March 2019 disclosed the drug had failed phase 3 testing. Biogen planned to write off the effort entirely. But in a stunning development that fall, Biogen said a review of a larger dataset justified an FDA filing. Within a year after Biogen's discontinuation news, the company's share price had recovered as it pushed forward, toward an FDA filing.
At the J.P. Morgan Healthcare Conference earlier this year, execs said they were already gearing up for launch. The company has finished construction on a plant in Switzerland that will produce the drug, CEO Michel Vounatsos told analysts April.
In another move that surprised analysts earlier this year, Biogen said it was pushing its FDA filing to the third quarter of 2020. That means an approval could come in 2021 or 2022, analysts wrote. Biogen execs insisted the delay wasn't caused by problems with the data, but instead the complexity of the application and challenges from COVID-19. The company is “prioritizing quality of submission versus the timing,” Vounatsos said at the time.