Industry watchers have known for a long time that Biogen's key multiple sclerosis med Tecfidera is slowing down. But compounding that problem is the fact that one of its main competitors isn’t.
Sanofi’s Aubagio is gaining ground, Citigroup analyst Robyn Karnauskas pointed out on last week’s Q4 earnings call, with new company CEO Michel Vounatsos confirming the trend, calling it “a very slight erosion."
“I have noticed what you have noticed,” he told Karnauskas and investors. “We can certainly see the inroads of Aubagio ... and we have to do a better job at that.”
Aubagio may still have room to steal share, too. The med could benefit if Sanofi pumped up its direct-to-consumer advertising efforts, which spark patient requests from doctors that are often granted, Jennifer Robinson, president at intelligence provider Spherix, recently told FiercePharma.
So what can Biogen do to help Tecfidera stand its ground?
“What is important is that we continue ... to perform, and that the team is able to generate ... the demand as expected,” Vounatsos said.
Biogen is counting on Tecfidera to help total revenues for 2017 reach between $11.1 billion to $11.4 billion, especially with overall MS revenue “slowing regardless of how you look at it,” as Leerink Partners analyst Geoffrey Porges put it last week in a note to clients.
While the company anticipates “relatively stable demand” for Tecfidera this year, though, it’ll be outside-the-U.S. expansion that’s “offsetting modest patient declines in the U.S.” and keeping the med afloat, Biogen CFO Paul Clancy said on the call.
“Outside the U.S., our efforts are aimed at both new country launches and a renewed focus on early launch European markets such as France and Germany,” Vounatsos said.
Unfortunately for Biogen, Aubagio isn’t the only reason the company foresees a Tecfidera slide at home. The drugmaker is readying itself for up-and-coming Roche rival Ocrevus, which could hit the scene at the end of March. Serious competition from the hot prospect is baked into Biogen’s guidance.
While Roche may have “very good” clinical trial data in hand, though, it’ll still need to be confirmed in an FDA-approved label to make a marketing difference. The drug will also have to prove itself "in the real world,” Vounatsos reminded investors. And “in the meantime, we have 250,000 patients” on Tecfidera.
“The safety perception and efficacy perception on our product is well characterized,” he said. “We have many cards to play, and play well."