Decision to halt Alzheimer's trial sends Biogen shares sliding

Biogen Halts Promising Alzheimer's Drug Trials Due to Disappointing Results

Biogen scraps two Alzheimer drug trials, wipes $18 billion from market value

Eisai Co Ltd on Friday said it has begun phase 3 clinical trials of Alzheimer's treatment BAN2401, a day after the Japanese drugmaker and USA partner Biogen Inc scrapped trials for another Alzheimer's drug, aducanumab.

The announcement took a punishing toll on Biogen, whose shares fell almost 30 percent to $227.82 in midday trading, its largest drop since February 2005, when Biogen shares fell almost 43 percent to close at $38.65 on Nasdaq.

"The decision was based on the data monitoring committee's futility analysis that the trials would not reach their primary endpoint".

As of Thursday morning, Biogen's share price had fallen to $230 from $320 at Wednesday's close. That drug failed in a 12-month analysis.

Analysts at Jefferies described the data as "all over the place" but said a phase 3 programme was justified, although those comments came ahead of the aducanumab failure.

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Without the potential revenue from an Alzheimer's drug, the company has poor growth prospects as it faces patent issues over its flagship Tecfidera multiple sclerosis drug and possible competition to spinal muscular atrophy drug Spinraza, Wall Street analysts said.

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

Between 2002 and 2012, a study recorded a 99.6% failure rate for clinical trials looking into bringing a treatment through to patients.

Eisai, which is partnering with Biogen Inc (NASDAQ: BIIB) on Alzheimer's research, announced the initiation of a global Phase 3 clinical study Thursday, dubbed Clarity AD/Study 301, of BAN2401, which is being evaluated in patients with early Alzheimer's disease. Detailed results of Study 201 were presented at Alzheimer's Association International Conference 2018 and Clinical Trials on Alzheimer's Disease 2018 in July 2018 and October 2018, respectively.

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

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Successful completion of these late-stage studies would have been a boon for Biogen as there are only a few treatments approved for Alzheimer's. BAN2401 selectively binds to neutralize and eliminate soluble, toxic Aβ aggregates (protofibril) that are thought to contribute to the neurodegenerative process in Alzheimer's disease. It is still assessing whether to conduct a separate aducanumab late-stage prevention trial.

Apart from aducanumab - for which trials were scrapped - the company has two more assets for Alzheimer's, namely BAN2401 and elenbecestat, both of which target amyloid plaques in the brain. "Aducanumab is dead, and we'd argue so is the beta-amyloid hypothesis". "I'm not completely there yet, but you'd certainly like to see some kind of positive response". In February of that year, the company halted the study for early-stage Alzheimer's patients.

A sign marks a Biogen facility in Cambridge, Massachusetts, U.S. January 26, 2017.

Dr. Howard Fillit of the Alzheimer's Drug Discovery Foundation said research must identify biomarkers and diagnostics to help "weed out ineffective drugs earlier", before they are tested in large, expensive trials.

He said BAN2401 is not that different from aducanumab.

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