Biogen’s 2022 fourth-quarter and full-year report comes the day after an additional warning on the company’s first Alzheimer’s drug came to light.
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Biogen anticipates middling market performance for its newly-approved Alzheimer’s therapy Leqembi (lecanemab), company leadership announced Wednesday in its 2022 fourth-quarter and full-year results.
The financial report comes after an additional warning on Biogen’s first anti-amyloid Alzheimer’s therapy, Aduhelm (aducanumab), came to light. The updated label alerts doctors to the risk of intracerebral hemorrhage in treated patients.
In an investor call Wednesday morning, Michael McDonnell, chief financial officer, Biogen, said the company expects commercialization expenses for Leqembi to exceed its revenue.
Still, the Massachusetts-based biotech is pinning its hopes on Leqembi, along with upcoming depression candidate zuranolone, as it grapples with declining revenues and growing biosimilar pressure.
Zuranolone, developed with Sage Therapeutics, has an FDA action date of Aug. 5, 2023.
Christopher Viehbacher, president and CEO, said during the call that both have the potential to be “quite transformative in their respective therapeutic areas.”
Biogen is also looking to grow its existing products, including multiple sclerosis drug Vumerity (diroximel fumarate) and Spinraza (nusinersen) in spinal muscular atrophy (SMA), Viehbacher said.
In total, Biogen made more than $10 billion in 2022, down from nearly $11 billion in 2021. Almost all of the company’s businesses demonstrated downward trends, including its multiple sclerosis, SMA and biosimilar products.
Biogen also revealed it had discontinued its neuropathic pain candidate vixotrigine due to “regulatory, development and commercialization challenges.” The oral sodium channel blocker showed early promise in the Phase II CONVEY trial, where a 200-mg twice-a-day dose significantly eased daily pain after 12 weeks.
The company has also terminated its licensing agreement with InnoCare Pharma and is returning oral Bruton’s tyrosine kinase inhibitor, orelabrutinib, to the Chinese company. In July 2021, Biogen paid $125 million to gain access to orelabrutinib and study it in multiple sclerosis.
Aduhelm Takes another Hit
Aduhelm, the first-ever therapeutic approved to treat an underlying cause of Alzheimer’s disease, is a human monoclonal antibody that targets amyloid beta plaques in the brain. The product launched in April 2021 and almost immediately attracted controversy.
In November 2021, Biogen reported that a 75-year-old woman treated with the drug died of amyloid-related imaging abnormalities (ARIA). Three other ARIA cases were reported from July to September 2021, all of which occurred outside the U.S. but required hospitalization.
In the new label adjustment, the FDA advised prescribers to inform their patients that though infrequent, cases of intracerebral hemorrhage exceeding 1 cm in diameter have been documented in patients taking Aduhelm.
The risk of brain bleeding might also be higher in patients who are also on antithrombotic or thrombolytic medications, the regulator noted.
The additional safety warning is unlikely to strongly impact Aduhelm sales, as few patients are on it to begin with after the U.S. Center for Medicare and Medicaid Services severely limited coverage of Aduhelm. Over the course of 2022, Aduhelm managed just $4.8 million in sales.
