While Biogen buckles under intense criticism for the Phase III failure of aducanumab for Alzheimer’s — triggering a review of what it should focus on next — its longtime neurosciences partner Eisai continues to build its investment in their controversial R&D work.
The biopharma player has recruited a pair of senior execs to join the Alzheimer’s team at Eisai, which stirred a considerable fuss with a ham-handed decision to start a Phase III trial for BAN2401 right after Biogen was forced to try and explain the aducanumab flop — after building their late-stage pipeline around that project.
Noting that the company is deepening its commitment to Alzheimer’s, Eisai wooed Harald Hampel to join the company as vice president, global medical affairs while Michael Irizarry has been named vice president, clinical research. Both will take leading roles on the Alzheimer’s programs.
Hampel is coming from the Sorbonne while Irizarry is jumping on after completing a stint at Eli Lilly, which has suffered its own late-stage fiascoes in Alzheimer’s over the years — most prominently with solanezumab and more recently with the failed Phase III BACE effort.
Eisai and Biogen are still working together on BAN2401, for now at least, as that program has weaved from one controversy to the next. First it was a Phase II failure, then researchers claimed a success before analysts pounced on a trial design feature forcing out high-risk patients that may have skewed the results.
They’re also still partnered on the oral BACE drug elenbecestat, even though they’ve never tracked cognitive rewards from the drug, which fits into a field that has seen a pair of decisive Phase III failures at Merck and Eli Lilly/AstraZeneca.
Both drugs are aimed squarely at amyloid beta, a toxic substance that often accumulates in the brains of patients. But after industry players spent billions of dollars on the theory, there’s no data to suggest that it works. Now some prominent analysts are demanding that Biogen back off and steer a new direction, while Eisai continues to plow its own course.
Eisai has been building a bespoke, $100 million R&D center in the Cambridge/Boston hub for its Alzheimer’s work.
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