Between slow sales, safety concerns and a likely European rejection, newly minted Alzheimer's disease drug Aduhelm has proven more of a headache than a blessing for developer Biogen. Now, the med's sluggish start could put Biogen jobs in jeopardy.
In the aftermath of Aduhelm's rocky launch, Biogen is gearing up for large-scale layoffs, Stat News reports, citing a Biogen employee close to the matter. The plan has yet to be finalized and still needs approval from the company’s board of directors, the publication writes. Overall, the staff squeeze could slash expenses by $500 million to $750 million, Stat said.
Biogen is not commenting on the matter, a company spokesperson said over email.
This wouldn’t be the first time slow sales prompted the company to cull its ranks. Back in 2015, citing dwindling sales of its multiple sclerosis med Tecfidera, Biogen fired 11% of its workforce or about 800 jobs.
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While the nitty-gritty of Biogen’s plans aren't yet known, the layoffs are expected to “exceed” the 2015 round of job cuts in terms of number of employees and cost savings, Stat reports.
The news comes just a few weeks after the revelation that Biogen’s longtime head of R&D, Al Sandrock, M.D., Ph.D., is leaving the company by the end of the year.
It’s not entirely clear why Sandrock is leaving, though his departure occurs against a backdrop of sharp criticism and meager sales of Aduhelm. There’s currently a federal probe investigating the FDA’s controversial approval of the drug. Meanwhile, Aduhelm posted just $300,000 in third-quarter U.S. sales.
In addition, Biogen last month received a “negative trend vote” on Aduhelm’s application from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use.
A trend vote isn’t a final verdict, but the formal decision likely won’t change unless major new information is provided, according to EMA guidance. The rejection has likely cost Aduhelm some 40% of potential future revenue, RBC Capital Markets analyst Brian Abrahams wrote in a note to clients last month.
Meanwhile, safety concerns continue to dog the drug. In November, reports surfaced that a 75-year-old woman in Canada being treated with Aduhelm had died. The death is still under investigation, though it appears her death was "likely" linked to the drug, RBC Capital Markets' Abraham wrote in a separate note to clients. The patient’s death seems to be related to a known side effect of Aduhelm called amyloid-related imaging abnormalities, or ARIA, the analyst, a non-practicing physician, wrote.
Roughly 40% of early Alzheimer’s patients taking Aduhelm in phase 3 studies experienced ARIA, according to a secondary analysis of two late-stage trials, Emerge and Engage, published last month in JAMA Neurology. About one-quarter of those patients experienced ARIA symptoms, the researchers said.