Biogen stands to lose billions in Tecfidera sales next year, analyst says after new court ruling – FiercePharma

Defending its blockbuster multiple sclerosis drug Tecfidera from generics hasn't been easy for Biogen lately, and the painful trend continuedthis week with a court ruling thatclears the way for more copycat drugs to launch.

After the Delaware patent court loss this week, multiple generics will likely roll out soon, Bernstein analyst Ronny Galpredictsand when they do, they'll siphon off most of Tecfidera's $3 billion-plus in U.S. sales.

Biogens multibillion-dollar drugcould have fared reasonably well against oneor twogenerics, Gal wrote this week, but the launch of several generics simultaneously will likely turn this market into a commodity generic, causing prices to fall steeply.

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The Delaware decision comes after a West Virginia court ruled against Biogen in June. After Mylan won a full generic approval from the FDA, the generic drugmaker launched its copycat despite the risk that BIogen might win on appeal.

Already, fouror five other companies have tentative generic approvals and could launchafter securingfinal FDA nods, Gal pointed out.Tecfidera pulled in $3.3 billion in the U.S. last year, the majority of which will now "probably be lost," Gal wrote.

RELATED:Biogen's lagging Vumerity, stalled by the pandemic, faces 'critical' stretch ahead, CEO says

Cost cuts at Biogen could follow. In court documents, the company laid outplans to makepainfulcuts if it lost the case, Gal wrote.But because Tecfiderahas a high margin and limited direct R&D spending, the analystsaid any direct cost cuts should be modest and that the company will cut marginal costs elsewhere.

A Biogen spokesman said the company is "disappointed" and will appeal. The company has "transformed" MS treatment over the span of more than two decades, he added, and "remains committed to advancing" treatment.

The Tecfidera losses will also prompt the company to pivot tofollow-up multiple drug Vumerity. That drug has yet to take off,generating just $11 million in the U.S. during the first half of the year.

RELATED:Mylan's Tecfidera generic launch jolts Biogen, putting billions at stake

In ruling against Biogen in Delaware,the judge largely relied on that prior decision from West Virginia because she felt that court in did a thorough job, Gal said in asynopsis.Biogen is appealing the loss in West Virginia, but Gal notes the rate of reversals is about 20%. His team sees no reason for deviation here.

Looking forward, Biogen now has even more on the line with aducanumab, its controversial Alzheimers disease drug candidate. Thedrugmakerlast year cancelled a phase 3 trial on the drug, but later said a larger data analysis warranted an FDA application. The FDA accepted the companys application last monthand set a decision date for March 7, 2021.

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Biogen stands to lose billions in Tecfidera sales next year, analyst says after new court ruling - FiercePharma