Eli Lilly and Roche are overpricing this week for the controversial approval of biogen’s anti-amyloid Alzheimer’s drug, aducanumab.
First up is Lily, who hit record highs this week and drew attention to the once well-promoted donanemab. This is another anti-amyloid with mixed data in March, about the more widely used measurement of Alzheimer’s disease, which won slightly on one disease scale weakened by failure.
Lily has shown much more conclusively that donanemab, which focuses on amyloid plaques, reduces the levels of misfolded protein aggregates in the brain. This was also what Biogen showed at Aduhelm, and this week it turned out to be enough to get full FDA approval, so Lilly’s inventory increased.
However, the major pharmaceutical companies decided to shelve everything but donanemab in the short term because they couldn’t see the direction of future regulation.
Mizuho Americas analysts, who spoke to Lily’s management this week, said it might have changed now. “Overall, this approval raises new questions for Lily. It seems (as many of us do!), “The company said in a note to its customers.
“They are looking to work with the FDA again to better understand the bars that donanemab needs to clear for faster regulatory approval.”
Meanwhile, Jeffreys analysts said the FDA accelerated approval of Aduhelm based on surrogate endpoints (not clinical benefit) for amyloid beta plaque reduction. 3 The GRADUATE test of anti-amyloid beta candidate gantenerumab It is now set as “a much lower hurdle than showing a clear cognitive benefit.”
Jeffreys remains cautious, but said, “It’s still unclear what position the FDA will take in this area if GRADUATE fails to recognize despite a significant reduction in Abeta.” The late-stage CREAD trial was discontinued due to waste, but research into the prevention of Alzheimer’s disease is currently underway.
For Jeffreys, this is “in our view, it has not been proven to reliably reduce the burden of amyloid plaques,” although the company estimates that global sales of gantenumab will be $ 3 billion. , The probability is 0%, “There is no contribution because it is likely.”
Roche is also hitting highs on the stock market this week. Investors are still hoping that the broader profile of Alzheimer’s disease will improve.
It also includes a pipeline to counter tau, and FDA approval “affects AD programs that target tau,” Jeffreys said.
Currently, mid-stage data for the Roche-AC immunity anti-tau antibody semolinemab in moderate Alzheimer’s disease are scheduled for later this year, but Phase 2 trials for mild disease have already failed.
Roche’s second anti-tau antibody, UCB0107, in partnership with UCB, will also enter more detailed trials this year. Tau appeared to have new potential as a type of amyloid rival. In Tau theory, changes in intracellular neurofibrillary tangles clog the brain and eliminate it in Alzheimer’s disease. It helps the patient.
This hasn’t been proven in the clinic, but since Aduhelm it’s probably no longer an issue.
https://www.fiercebiotech.com/biotech/eli-lilly-roche-s-alzheimer-s-prospects-including-flops-boosted-light-fda-s-aduhelm Eli Lilly, in light of FDA Aduhelm approval, Roche’s outlook for Alzheimer’s disease, including failure, was boosted: Analysts