Biogen CEO to step down; drugmaker pulls back on Alzheimer’s drug Aduhelm

Might 3 (Reuters) – Biogen Inc (BIIB.O) mentioned on Tuesday that chief govt Michel Vounatsos will step down and that the corporate is pulling again on promoting its controversial Alzheimer’s drug Aduhelm, in what seems to be a remaining blow to its prospect of changing into a giant vendor.

The way forward for Aduhelm has been unsure because the U.S. authorities’s Medicare program restricted protection of the drugs to sufferers in scientific trials. learn extra

Aduhelm was anticipated to be the corporate’s subsequent massive blockbuster remedy, however controversy over its approval with out clear proof of affected person profit and the U.S. resolution to severely restrict entry forged severe doubt on its gross sales potential.

Biogen said on Tuesday it was taking a look at “considerably” eliminating industrial infrastructure associated to Aduhelm and plans for extra value cuts, along with the present program to save lots of $500 million yearly.

Biogen final month determined to withdraw its advertising and marketing utility for Aduhelm in Europe after failing to persuade the European regulator of the remedy’s advantages. learn extra

The corporate mentioned it’ll retain minimal sources to make Aduhelm out there to sufferers at present taking the drug in america.

Vounatsos, who was named because the CEO in 2016, will proceed in his position till a successor is appointed, the corporate mentioned. Underneath his management, the U.S. biotech developed and launched a number of necessary progress drivers together with spinal muscular atrophy drug Spinraza and a number of sclerosis drug Vumerity.

“The information (about Vounatsos) isn’t a surprise, given the various setbacks the corporate has confronted,” mentioned RBC Capital Markets analyst Brian Abrahams, including that it “might assist add to the notion that Biogen will flip the web page from being overly levered to Alzheimer’s to assembling a extra numerous pipeline.”

Biogen shares have been up about 1.3% at $210.03 on Tuesday. The inventory is down 47% since Aduhelm was accepted in June.

The corporate was betting on Aduhelm, the primary new remedy for the memory-robbing illness in practically 20 years, to behave as a buffer as its primary established income drivers face rising competitors.

The U.S. Meals and Drug Administration accepted the remedy final June regardless of a scarcity of clear proof that it slowed cognitive decline and over objections of the company’s panel of outdoor skilled advisers.

Aduhelm had gross sales of simply $2.8 million within the first quarter, lacking analysts’ diminished estimates. The corporate mentioned its earnings have been hit by a $275 million Aduhelm stock write-off.

Excluding objects, Biogen earned $4.38 per share, in keeping with analysts’ estimates.

Vounatsos referred to as the setbacks confronted by the corporate within the final 12 months “important,” however mentioned Biogen remained dedicated to Alzheimer’s illness.

Biogen remains to be relying on a second Alzheimer’s drug, lecanemab which, like Aduhelm, was developed with Japanese firm Eisai Co. Ltd (4523.T).

Biogen plans to finish a rolling submission of information for lecanemab beneath the U.S. accelerated approval pathway within the present quarter earlier than submitting it for full approval in 2023.

On Tuesday, Eisai revised down its working revenue forecast for the 12 months ended March 31 by 31.4% to 53.5 billion yen ($411 million), citing the impression of the U.S. protection coverage for Aduhelm.

($1 = 130.1300 yen)

Reporting by Leroy Leo and Mrinalika Roy in Bengaluru; Further reporting by Makiko Yamazaki in Tokyo; Enhancing by Shounak Dasgupta and Invoice Berkrot

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