A Biogen facility in Cambridge, Massachusetts.
Brian Snyder | Reuters
Biogen’s Chief Government Officer Michel Vounatsos is stepping down, at a time the drugmaker is grappling with Medicare proscribing protection for its Alzheimer’s drug Aduhelm to sufferers in medical trials.
Vounatsos, who will proceed in his position till his successor is appointed, was named because the CEO in 2016 and has been on the helm as Biogen developed and launched a number of flagship medication together with spinal muscular atrophy drug Spinraza, a number of sclerosis drug Vumerity and most lately Aduhelm.
Biogen mentioned on Tuesday it was considerably eliminating industrial infrastructure associated to the Alzheimer’s drug and plans for extra value cuts, along with the present program to avoid wasting $500 million yearly.
Protection for Aduhelm is restricted to sufferers in medical trials, and the corporate mentioned it’s going to retain minimal assets to make the drug obtainable to sufferers at the moment on therapy within the U.S.
The corporate was betting on Aduhelm, the primary new therapy for the memory-robbing illness in almost 20 years, to behave as a buffer as its essential income drivers face rising competitors.
Nonetheless, Aduhelm has confronted a number of hurdles after the U.S. Meals and Drug Administration accepted it final June beneath an accelerated approval pathway.
Since then, investigations have been launched into the FDA’s determination taken over objections of its personal exterior advisers, medical doctors have held again on prescribing the drug and the U.S. Medicare operator in April determined to restrict protection of Aduhelm beneath the federal government insurance coverage plan.
“We predict the Road will view robust adjustments as a transfer in the suitable course for the sake of BIIB sentiment, longer-term spend and want to maneuver ahead … the adjustments have been talked about beforehand … however the timing was not essentially anticipated this quickly,” Jefferies analyst Michael Yee mentioned in a word.
Biogen is now relying on its second Alzheimer’s drug lecanemab, which like Aduhelm, has additionally been developed with Japanese firm Eisai Co. Ltd.
Biogen plans to finish the rolling submission for lecanemab beneath the accelerated approval pathway within the U.S. within the second quarter.