Biogen’s Q3 revenue falls 10% as focus shifts to new Alzheimer’s and ALS drug candidates – Endpoints News

Biogen’s Q3 revenue falls 10% as focus shifts to new Alzheimer’s and ALS drug candidates – Endpoints News

While Biogen’s third-quarter revenue fell 10% from a year earlier, the company focused its earnings on two bright prospects — recently disclosed positive results for lecanemab, its anti-amyloid Alzheimer’s follow-up Aduhelm and its potential ALS drug tofersen.

The FDA has until January 6, 2023 to decide on lecanemab’s accelerated approval, and Biogen executives, which have partnered with Eisai on the new drug with a 50-50 profit split, indicated that a full approval filing would soon follow in the US, EU and Japan before the end of the 1st quarter 2023.

Even with full approval, questions remain as to whether CMS will cover the drug.

Outgoing Biogen CEO Michel Vounatsos told investors that Eisai is taking the lead in talks with CMS, but he gave no assurances that lecanemab would be covered under an accelerated approval or a full approval.

“It depends on the strength of the evidence,” he said. Full data on lecanemab will be presented at the CTAD conference at the end of next month.

Priya Singhal

Priya Singhal, interim head of R&D, added that for the accelerated approval scenario, “it’s essentially just coverage in a randomized controlled trial, which is essentially non-coverage” as it was for Aduhelm. But for traditional approval, she said, “there are a number of options” from coverage in a CMS-approved prospective comparative study, including a registry.

“The strength and rigor of that type of study will depend on the strength and rigor of the randomized controlled trial that provides the final traditional approval,” Singhal said. “So in that sense, we feel very confident” in the strength of the recently unveiled positive study for lecanemab.

Michael McDonnell

As for the ramp-up to commercialize lecanemab, CFO Michael McDonnell said it was not reasonable, between the Aduhelm decision on coverage and the reading of lecanemab, to keep a large sales force on board, but he says he feels confident that the ramp on expenses will be more closely related to revenues for lecanemab than was seen for Aduhelm.

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An FDA decision on tofersen, an antisense drug developed to treat a genetic subset of ALS, is due next April. But that timeline was recently delayed by three months due to an information request.

Using a functional rating scale that measures patient symptoms as the primary measure, the tophersen failed a phase III test late last year. But Biogen is trying to win accelerated approval based on the drug’s effect on neurofilament light chain, a surrogate biomarker that some researchers believe can measure neuronal cell death.

However, the FDA has never approved a drug based on a drug candidate’s purported neurofiring-lowering effect.

Biogen’s global MS revenue, including Ocrevus royalties, fell 11% in the quarter, and Tecfidera’s revenue fell 32% due to the launch of generic drugs.

Biogen even slightly raised expectations for full-year 2022 revenue, to between $10 billion and $10.15 billion (from $9.9 billion to $10.1 billion), which it said: “is primarily driven by better than expected top line performance and continued cost management.”

Biogen recently offloaded $600 million worth of Massachusetts-based property and hundreds of employees tied to its weak Aduhelm sales, thanks to the CMS decision on national coverage that mandated additional RCTs. Biogen said Tuesday it has sold $4.5 million worth of Aduhelm in the first nine months of this year.

As for who might succeed Vounatsos, no updates were offered in today’s announcement. J&J’s Mathai Mammen recently emerged as a top contender.

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