Report: Biogen Eyes Massive Layoffs in Wake of Disappointing Aduhelm Rollout
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Massive layoffs could be headed to Biogen due to the disappointing rollout of its Alzheimer's drug Aduhelm that generated only a few million dollars in revenue over the past two quarters. The company could lay off as many as 1,000 employees as it continues to deal with the controversial treatment.
According to a report by STAT News, Biogen could eye saving up to $750 million with the cuts. The process is still being ironed out by the company's leadership and board of directors, but the axe could fall before the end of the holiday season, leaving many people looking for a new job in 2022.
Additionally, some of the blame for Aduhelm's failure is being placed on the company's head of R&D, Alfred Sandrock, who announced his plans to depart the company at the end of this year. According to the report, Biogen Chief Executive Officer Michael Vounatsos was behind Sandrock's sudden departure from the company. Although Sandrock has been behind the development of multiple treatments for neurological diseases, including Spinraza, the first drug approved to treat spinal muscular atrophy, the battering the company has taken over Aduhelm has been too much for the CEO.
Citing conversations "with people close to the situation," STAT said Sandrock is being forced to shoulder the blame for the controversial approval of Aduhelm, as well as its less than impressive commercial launch.
Publicly though, Vounatsos called Sandrock a visionary who dedicated his life to developing medications for some of the most devastating diseases. He called Sandrock "one of the most recognized drug developers of his generation." Vounatsos said the R&D chief has been an inspiration to research scientists and played a crucial role in turning Biogen into a Fortune 500 company.
In an email to BioSpace, Biogen said it is not commenting on the specifics of the pending layoffs and said the information was “largely told from the perspective of critics hiding under the cover of anonymity.” Despite that, Ashleigh Koss, global head of Corporate Communications at Biogen praised Sandrock for his dedicated service to the company and denied nefarious reasons behind the departure. She said Sandrock issued an internal note that highlighted his reasons for stepping down from his role at the company.
“While there’s never a perfect time, with a strong R&D team in place and Aduhelm having been approved, he decided that now is the best time,” Koss said.
Aduhelm (aducanumab) was approved by the U.S. Food and Drug Administration (FDA) in June under accelerated approval. The greenlight was highly controversial due to an overwhelming rejection of the medication by the FDA's advisory committee members. Several members of the advisory committee resigned following the regulatory agency's decision to approve the drug.
As BioSpace has reported, Aduhelm's development has been rocky. Biogen and its partner Eisai were prepared to abandon the development of the drug following a clinical trial futility analysis that suggested the drug would not hit its endpoints. However, the companies then reversed the abandonment following another investigation that suggested the trial data achieved its endpoints.
Sales have been disappointing for the company due to concerns over Aduhelm's safety.
Throughout the drug's clinical development, researchers observed cases of amyloid-related imaging abnormalities (ARIA-E), or cerebral edema. Last month a woman who was taking Aduhelm died of a cerebral edema. It has yet to be shown whether her death was related to the medication, but that has given pause to prescribers who may wish to offer the medication to patients.
While Aduhelm was approved in the United States last month, the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) gave the Alzheimer's drug a thumbs down.
Despite the shaky start, Biogen has stood behind the medication and continues to generate data that supports the safety and efficacy of the drug. At the recent Clinical Trials on Alzheimer's Disease conference, Biogen presented data from two Phase III trials that showed treatment with Aduhelm reduced amyloid plaque and significantly lowered plasma p-tau181, a biomarker of tau tangles in Alzheimer's disease.
Another longtime Biogen employee who could be leaving the company is Alphonse Galdes, who oversees global manufacturing. STAT noted that Galdes has been seen as a "stabilizing force" in the company's management for nearly 30 years. It is unclear whether or not Galdes is being forced out, as the report suggests Sandrock was, or if his departure has been planned for some time.