Biogen, Alkermes win FDA approval of Tecfidera successor — but can they actually sell it?
Just a few months after nailing Phase III data demonstrating the greater tolerability of Vumerity compared to the blockbuster franchise therapy it’s designed to replace, Biogen and their partners at Alkermes have won an FDA approval to start marketing the treatment for multiple sclerosis.
Like much of what Alkermes is known for, the drug’s future success will hinge on an improved safety profile, with fewer gastrointestinal side effects for MS patients. That will be the key argument that Biogen will use to woo patients away from their big drug Tecfidera ahead of generic competition — a cheaper alternative that payers will likely prefer over the new-and-improved drug.
It’s an important advance for both of these companies. Alkermes just triggered a restructuring aimed at eliminating $150 million in expenses, and Evercore ISI analyst Umer Raffat did the math showing that a billion dollars of Vumerity sales will add $150 million in revenue to Alkermes, which needs the boost as its market cap has shriveled.
Analysts are giving Biogen until 2023 to get ahead of the generic competition, which will shred their revenue from that drug. But Cowen’s Phil Nadeau counts himself as a skeptic when it comes to the pitch they’re making to transfer patients to Vumerity. He noted recently:
The difference in rates of flushing, diarrhea, nausea, and discontinuations are on the order of 4 – 7 percentage points. While 4 – 7 percentage point improvements are notable, we question whether these benefits are substantial enough for physicians (and payors) to use Vumerity in front of a generic version of Tecfidera. Moreover, we suspect that the majority of patients on Tecfidera tolerate it, and therefore would be unlikely to switch to Vumerity.
Biogen experienced a debacle with the failure of aducanumab earlier in the year, then enjoyed an overnight comeback with their claim that they snatched positive data out of the jaws of defeat. Overall the news today is another plus, but like aducanumab, the big biotech still has a lot of work to do to prove it can deliver.