Biogen's multiple sclerosis business has been treading water and its best-selling med, Tecfidera, might just run up against early generics. But now, the company has its next launch—and, it hopes, Tecfidera replacement—in the newly FDA-approved MS med Vumerity.
The Tecfidera follow-up won approval Wednesday, and Biogen touted it as a just-as-effective, better-tolerated version of its multibillion-dollar predecessor—and pharma watchers can expect the company to use that advantage to push patients toward the newer drug.
Vumerity "offers the well-characterized efficacy” of Tecfidera and "has been studied for improved patient-reported gastrointestinal tolerability,” Chief Medical Officer Alfred Sandrock said in a statement.
The nod comes as Tecfidera, Biogen’s top drug by sales, battles new competitors, including Roche's fast-launching MS star Ocrevus. And Tecfidera faces an intellectual property challenge from Mylan that could cut short its exclusivity. The key drug posted a 3% revenue increase in the third quarter to $1.12 billion.
As for the follow-up med, Bernstein analysts have said it will grow to $734 million by 2022 as Tecfidera sales shrink.
With the approval, Biogen owes its partner Alkermes a $150 million milestone payment, and the biotech stands to collect a mid-teens royalty on global sales.
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Vumerity will be one of Biogen's most important new drugs, but the approval news pales alongside the bombshell Biogen dropped last week when it revived Alzheimer’s candidate aducanumab. A futility analysis this spring determined the drug wouldn’t help patients, but Biogen now says a new analysis of a larger dataset sets the drug up for a potential FDA approval. The drugmaker is now in talks with the agency and working on a filing.
Just how the effort will play out remains to be seen—after previous data disappointments, some analysts are wary—but excited investors drove shares up by 26% on the news.
Outside of MS and Alzheimer's disease, Biogen's spinal muscular atrophy drug Spinraza has surpassed early expectations, but it's facing a threat from Novartis' new gene therapy Zolgensma and a potential entrant in Roche and PTC Therapeutics' risdiplam.