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Endpoints 24Jun2021 Article "On heels of Aduhelm approval, Bristol Myers jumps back into Alzheimer's race"June 24, 2021 10:59 AM EDT Deals On heels of Aduhelm approval, Bristol Myers jumps back into Alzheimer's race Jason Mast Editor Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether. But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road. The option comes just two weeks after the FDA’s controversial decision to approve Biogen’s amyloid clearing antibody Aduhelm, a move that has already changed the calculus for other companies developing Alzheimer’s therapies. Thursday morning, Eli Lilly reversed course and announced that they would file for approval for their amyloid-clearing therapy later this year, before it has gone through Phase III trials. They’re relying on an accelerated approval pathway the FDA opened in order to approve Aduhelm. Before the FDA decision, experts predicted that an approval would spur pharma companies to spend millions, if not billions, developing similar amyloid-clearing drugs, potentially pulling much-needed cash away from long-overlooked rival approaches. The impact on tau-targeted therapies is less clear, but the two approaches have similarities. Both rely on clearing out misshapen proteins that build up in the brains of Alzheimer’s patients, and the FDA’s willingness to conditionally approve drugs based on amyloid clearance could open the door for them to do the same with tau. It’s far from apparent, though, whether eliminating tau can actually slow patients’ mental decline. Bristol Myers’ decision to opt-in on the Prothena therapy comes a week after Biogen announced that the tau therapy they licensed from the Big Pharma in 2017 failed to make a dent on cognition in a large trial. A tau-targeted therapy from Roche similarly flopped. Some longtime critics of the amyloid hypothesis fear that the field, recognizing that an amyloid drug will likely never make a major dent on the disease, has coalesced around another red herring protein. Alberto Espay “We’re essentially turning from one church, the Church of Amyloid, to another church: the Church of Tau,” Alberto Espay, a neurologist at the University of Cincinnati, told Endpoints News before the FDA decision. “We’re living the definition of insanity.” Bristol Myers thinks Prothena’s drug can succeed where previous drugs failed because it targets a different part of the tau protein, an argument that will be familiar to longtime followers of pharma’s on-and-off-again love affair with amyloid. Previous drugs targeted the N-terminus region on the end of the protein. Prothena goes after a section in the middle called the microtubule binding region, or MTBR, that they believe is important to stopping tau from spreading across the brain. “PRTA anti-tau has a differentiated approach compared to others that may be of particular interest to BMY,” Jefferies analyst Michael Yee wrote. “PRTA and BMY have spent significant time over the last years developing this asset and are keen on the MTBR region as important to stop the cell-to-cell spread of tau.” Bristol Myers acquired the Prothena collaboration as a part of their $74 billion buyout of Celgene, who originally teamed with the Irish biotech in 2018. Prothena’s shares $PRTA were up 10% Thursday, from $48.11 to $52.91. With multiple tau and amyloid targeted assets in their pipeline, they’ve nearly doubled in value since the FDA chose to approve Aduhelm on June 7. |
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