Biogen Shares Plunges After Halting Phase 3 Of Alzheimer’s Disease Drug Trials

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Many companies including Biogen, Eisai, Lilly and AbbVie, are pursuing alternative approaches, such as focusing on tau, another Alzheimer's protein that is more closely linked with the onset of symptoms.

Eisai will conduct phase 3 trials of BAN2401 involving 1,566 patients with mild cognitive impairment or mild Alzheimer's disease dementia with confirmed amyloid accumulation. An independent data monitoring committee determined that completed studies were unlikely to show that the investigational compound benefited people with Alzheimer's when compared with placebo, the companies said. Safety concerns have played for the termination of the studies, no matter, - said Biogen.

"This disappointing news confirms the complexity of treating Alzheimer's disease and the need to further advance knowledge in neuroscience", said Michel Vounatsos, Biogen's chief executive officer.

Biogen is the latest pharmaceutical company to stop the research on treatment for Alzheimer's. Late-stage studies will still proceed this year as planned, Holman said. One of them is Allergan's Namenda. But the magnitude of the blow Thursday could make Biogen vulnerable to acquisition by a bigger suitor, or force it to go shopping for a large enough asset to replenish its labs with something of similar potential.

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"We view this as a transformative failure for Biogen's pipeline", RBC Capital Markets analyst Brian Abrahams wrote in a research note.

Alzheimer's, a fatal illness that causes progressive decline in memory, is a highly challenging area as multiple pharma companies have failed in their attempts to develop treatment.

BAN2401 has been seen as something of an also-ran in the Biogen/Eisai pipeline, particularly after reporting confusing results in a phase 2b trial past year.

In January 2019, Roche RHHBY discontinued two late-stage studies evaluating its Alzheimer's disease candidate, crenezumab. After its candidate, gantenerumab, failed an earlier test four years ago, Roche chose to ratchet up the dose and try again with a pair of big late-stage trials.

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Eisai said the Phase 3 study is meant to support a regulatory filing for the asset following discussion with regulatory agencies based on the results of a Phase 2 study.

Aducanumab was targeted at soluble beta amyloid, and some researchers now think that neurotoxic amyloid beta aggregates - which are the target for BAN2401 - are in fact the key driver of AD pathogenesis. Roche's partner on the second compound, Alzheimer's specialist AC Immune, at one point fell more than 12 percent in premarket trading in NY.

Biogen BIIB, -29.02% and drug development partner Eisai Co.

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