The need for Biogen Inc. (BIIB, Financial) to get its Alzheimer’s drug approved became more urgent this week after the company lost a patent dispute over its top-selling medication.
A West Virginia District Court ruled that a key patent covering Biogen's multiple sclerosis medicine Tecfidera is invalid, a win for the generics company Mylan (MYL, Financial), which could have a copycat on the market as early as next year, according to an article in BioPharma Dive.
The disappointing news shaved about $25 off Biogen’s share price this week, but the stock did bounce back, gaining more than $10 on Friday to close at about $271. Biogen has traded as high as nearly $375 this year.
With the patent setback, Biogen and its investors are now pinning their hopes on the Alzheimer’s drug, aducanumab. Like a phoenix rising from the ashes, aducanumab got new life after it was labeled all but dead last October, when Biogen and its partner Easai Co.Ltd. (TSE:4523, Financial) said they were stopping phase 3 testing because the drug simply wasn’t working.
Shortly thereafter, Biogen made a 180-degree turn and said that based on additional data that showed aducanumab was effective against Alzheimer’s, it would file for U.S. Food and Drug Administration approval. So far that hasn’t happened, though Biogen has said it will be done later this year.
Aducanumab’s importance to the Cambridge, Massachetts-based company can’t be overstated. Generic competition could take a big chunk out of Tecfidera sales, which accounted for more than 30% of Biogen’s $14.4 billion in revenue last year.
Biogen is facing a threat on another front, too. Its second best-selling drug, Spinraza, for muscular atrophy, is being challenged by the Novartis (NVS, Financial) gene therapy and another competitor, from Roche (RHHBY, Financial), is on the horizon. To supplement its core MS franchise, Biogen has a pipeline full of what BioPharma Dive called “risky” neuroscience-based drugs.
Biogen said it was disappointed at the decision on Tecfidera and plans to appeal the ruling.
Yet "Biogen themselves seem to acknowledge that a loss here would likely mark the beginning of the end for Tecfidera’s exclusivity," wrote Piper Sandler analyst Christopher Raymond in a note this week.
Biogen does have a more tolerable version of Tecfidera called Vumerity, which was co-developed with Alkermes (ALKS, Financial). But since being approved last October, Vumerity hasn’t done much, bringing in only $7 million during the first two quarters it’s been on the market.
Vumerity "really isn't all that differentiated from Tecfidera," Stifel analyst Paul Matteis wrote.
"Given this dynamic, as well as what we see as little more than a lottery ticket with respect to the aducanumab Alzheimer’s filing/FDA review, we are hard pressed to articulate a bullish thesis," Raymond wrote.
Disclosure: The author holds no positions on any of the stocks mentioned in this article.
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