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Biogen Alzheimer’s Drug Hits Delays Caused by Data, Covid-19

Biogen Alzheimer’s Drug Hits Delays Caused by Data, Covid-19

(Bloomberg) -- Biogen Inc. said it now plans to submit a closely watched experimental Alzheimer’s drug for U.S. approval in the third quarter, after data-processing challenges and a coronavirus outbreak that sickened numerous employees derailed a more ambitious timeline.

The Cambridge, Massachusetts-based biotechnology company had indicated it would seek approval from the U.S. Food and Drug Administration for its drug, aducanumab, in early 2020. After abruptly abandoning study of the therapy last year, Biogen just as suddenly revived it months later, raising hopes it could be the first to bring such a treatment for the memory-destroying disease to market.

The delay on Wednesday caused Biogen’s stock price to fall by the most since the company ended the aducanumab trial last March. Shares declined as much as 12%, wiping out more than $6.4 billion in market value.

Pressed by Wall Street analysts on a conference call, Chief Executive Officer Michel Vounatsos said there were “two main reasons” for the delay. First, he said, data from the aducanumab study was unusually difficult to process. Second: Covid-19.

Employees spanning all levels of Biogen management contracted the illness caused by the novel coronavirus. All have recovered, or are recovering, Vounatsos said, and most employees affected by the virus continued to work. But the physical effects of the illness have made the challenging tasks of the researchers harder to carry out.

“Some members of the team, they did get Covid, and I can tell you it’s hard to work when you have Covid,” Executive Vice President of R&D and Chief Medical Officer Alfred Sandrock said on the call. “The mental and physical fatigue was such that there were some people who were affected by the disease.”

Complex Data

Despite the strain created by the virus, both executives said the primary reason for the delay was a highly complex dataset that required additional processing.

“We are prioritizing the quality of the submission,” Vounatsos said. “Not the timing.”

The company said it has a Biologic License Application with the U.S. Food and Drug Administration, and has begun submitting modules of the filing. It’s preparing for a preliminary meeting with the agency that is set for the summer. Executives told investors that they’ve received encouragement from the FDA and that the pre-BLA meeting is standard.

Biogen also initiated a redosing study for aducanumab. Vounatsos said he doesn’t believe that study is required for the regulatory filing.

The twists and turns around aducanumab have made Biogen shares exceptionally volatile over the past year. When Biogen said in October it was reviving the drug, its stock soared, and the shares had been among the best performing large-cap health-care stocks ahead of Wednesday’s first-quarter earnings release.

The “Alzheimer’s saga drags on,” wrote Citigroup Inc. analyst Mohit Bansal in a note. He said the shifting time line “does not appear good, especially when many investors do not believe in the Alzheimer’s story in the first place.”

The delayed filing stole the spotlight from first-quarter results that were stronger than many on Wall Street anticipated. Sales of blockbuster multiple sclerosis medicines Tysabri and Tecfidera topped estimates as patients around the world stockpiled drugs amid the coronavirus pandemic.

Vounatsos told investors that uncertainty surrounding the pandemic poses unquantifiable risks to the biopharmaceutical business and near-term financial results. Still, the chief executive said “compelling opportunities exist in the therapeutic areas we are pursuing,” like Alzheimer’s.

©2020 Bloomberg L.P.