USA – Biogen Inc. has announced that it is letting go of CEO Michel Vounatsos and effectively abandoning its high-profile Alzheimer’s disease treatment Aduhelm as it tries to chart a new course following Medicare’s devastating refusal to pay for it.
Aduhelm’s future was thrown into disarray following the announcement by United States government’s Medicare program to limit coverage of the medicine to patients in clinical trials.
Biogen announced that Mr. Vounatsos, 60, would continue to lead the company and serve on its board of directors until a new CEO is found. It also took steps that effectively put an end to its marketing of the Alzheimer’s drug.
In this regard, the company said it will retain minimal resources to make Aduhelm available to patients currently taking the drug in the United States.
Vounatsos, who was appointed CEO in 2016, will remain in his position until a successor is named, according to the company. Under his direction, the US biotech developed and launched several key growth drivers, including the spinal muscular atrophy drug Spinraza and the multiple sclerosis drug Vumerity.
The company was banking on Aduhelm, the first new treatment for the memory-robbing disease in nearly two decades, to act as a buffer as its main established revenue drivers face increased competition.
Despite a lack of clear evidence that it slowed cognitive decline and despite the agency’s panel of outside expert advisers’ objections, the Food and Drug Administration approved the treatment last June.
Aduhelm’s first-quarter sales were only US$2.8 million, falling short of analysts’ lower estimates. Aduhelm inventory write-off of US$275 million hurt the company’s earnings.
Aduhelm was expected to be the company’s next big blockbuster treatment, but controversy surrounding its approval without clear evidence of patient benefit, as well as the United States’ decision to severely restrict access, cast serious doubt on its sales potential.
Biogen said that it was considering “substantially” eliminating commercial infrastructure related to Aduhelm, as well as additional cost-cutting measures in addition to the current US$500 million-a-year program.
Biogen withdrew its marketing application for Aduhelm in Europe last month after failing to persuade the European regulator of the treatment’s benefits.
All is not lost for Biogen as it is still banking on a second Alzheimer’s drug, lecanemab, which, like Aduhelm, was developed in collaboration with the Japanese firm Eisai Co. Ltd.
Biogen intends to complete a rolling data submission for lecanemab under the accelerated approval pathway in the United States in the current quarter before submitting it for full approval in 2023.