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Biogen delays filing of Alzheimer’s drug, which hits its share price

Company still reported solid first-quarter financial results

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Biogen has confirmed that its much-anticipated regulatory filing for Alzheimer’s disease candidate aducanumab will be delayed, weighing on its shares despite solid first-quarter financial results.

The company said the delay in the marketing application to the third-quarter was caused by the ongoing coronavirus pandemic, but that failed to reassure investors already nervous about the prospects for the drug, and yesterday its shares were down by more than 11% after the announcement.

Biogen has felt the impact of COVID-19 more than most biopharma companies, as it suffered its own outbreak a few weeks ago after dozens of employees became infected at a management meeting in Boston. Some of the employees working on aducanumab were affected, according to chief executive Michael Vounatsos.

In its first-quarter results update, Biogen said it has already started filing some modules as part of the Biologics License Application (BLA) to the FDA, but doesn’t expect to have a meeting with the regulator until the summer. It had previously suggested it could file the soluble amyloid-targeting antibody in the US in early 2020.

Aducanumab was written off last year by Biogen and Eisai, its development partner for the drug, after an initial look at data from two phase 3 trials suggested the drug was unlikely to show a clinical benefit.

The EMERGE trial gave a positive if modest readout for the high-dose aducanumab arm on cognition scores, but ENGAGE didn’t reproduce those findings.

The setback strengthened calls to abandon the so-called ‘amyloid hypothesis’ of Alzheimer’s disease, which is based on the premise that blocking the formation of the amyloid plaques that are evident in the brains of patients with this type of dementia could prevent neurodegeneration and the resulting declines in memory and cognitive function.

A few months later, however, it was all change, as Biogen said a fresh look at data from the two trials had revealed a benefit in patients taking a higher dose of the antibody over a longer period of time, and outlined a plan to file for approval.

Biogen has been forced to defend the drug’s resurrection, however, with some experts saying the rejigged data is complex, hard to interpret and doesn’t meet the FDA’s usual requirements for approval.

Others say the FDA is unlikely to turn the drug down even if the data is modest as the need for a treatment for Alzheimer’s is so acute. GlobalData has said that, if approved, it could become a multibillion-dollar blockbuster.

Aside from the disappointment over aducanumab, Biogen’s first-quarter results were solid, with a 1% increase in revenues to $3.53bn, ahead of analyst expectations and driven by its multiple sclerosis therapies and spinal muscular atrophy therapy Spinraza (nusinersen), which grew by 9% to $565m.

Article by
Phil Taylor

23rd April 2020

From: Research

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