Biogen mulls massive layoffs following disappointing Aduhelm rollout: Report

USA – Biogen is planning to lay off over 1000 employees following the disappointing launch of its Alzheimer’s therapy Aduhelm (aducanumab), according to STAT News.

According to STAT News, Biogen could save up to US$750 million with the cuts. The company’s leadership and board of directors are still working out the details, but the axe could fall before the end of the holiday season, leaving many people looking for work in 2022.

Furthermore, Alfred Sandrock, the company’s head of R&D, has announced his intention to leave the company at the end of this year, is being blamed for some of Aduhelm’s failure.

According to the report, Sandrock’s abrupt departure from Biogen was the result of a disagreement with Biogen CEO Michael Vounatsos.

Despite the fact that Sandrock has been involved in the development of numerous treatments for neurological diseases, including Spinraza, the first drug approved to treat spinal muscular atrophy, the company’s battering under Aduhelm has been too much for the CEO.

According to STAT, citing “conversations with people close to the situation,” Sandrock is being forced to bear the blame for Aduhelm’s controversial approval, as well as its less-than-impressive commercial launch.

This would not be the first time the company had to reduce its workforce due to slow sales. Biogen laid off 11% of its workforce, or approximately 800 people, in 2015, citing dwindling sales of its multiple sclerosis drug Tecfidera.

While the specifics of Biogen’s plans are unknown, the layoffs are expected to “exceed” the 2015 round of job cuts in terms of employee numbers and cost savings, according to STAT.

Meanwhile, due to concerns about Aduhelm’s safety, the company’s sales have been disappointing Aduhelm only made US$300,000 in sales in the third quarter in the United States.

A federal investigation is currently underway into the FDA’s contentious approval of the drug. The U.S. Food and Drug Administration (FDA) approved Aduhelm (aducanumab) under accelerated approval in June.

The approval was highly contentious due to an overwhelming rejection of the medication by members of the FDA’s advisory committee.

Following the regulatory agency’s decision to approve the drug, several members of the advisory committee resigned.

Aduhelm’s rocky journey

Aduhelm’s development has been rocky. Following a clinical trial futility analysis that suggested the drug would not meet its endpoints, Biogen and its partner Eisai were prepared to abandon development of the drug.

However, the companies reversed their decision after another investigation revealed that the trial data met its endpoints.

Furthermore, Biogen received a “negative trend vote” on Aduhelm’s application from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use earlier this month.

According to EMA guidance, a trend vote is not a final decision, but the formal decision is unlikely to change unless significant new information is provided.

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