Roche and Shire are taking their hemophilia battle across the pond.
Following Shire’s EU approval for Adynovi last week, Roche has nabbed a European approval recommendation for Hemlibra, a first-in-class hemophilia A medication that analysts expect to reach blockbuster heights.
While the highly anticipated product is still waiting for an approval, it’s been available in one country on the continent since early this month, when the U.K.’s Medicines and Healthcare Regulatory Agency granted a positive opinion under its early-access program.
In the U.S., Hemlibra snagged its go-ahead in mid-November, putting Shire and its hemophilia franchise—which came over in its 2016, $32 billion Baxalta buy—on notice. Right now, Hemlibra is approved to treat only those hemophilia A patients who have developed factor VIII-inhibiting antibodies. But some industry watchers are predicting big things—think $5 billion in annual sales, Jefferies analysts say—if the drug can move into the larger, noninhibitor population.
Shire, for its part, doesn’t see factor VIII treatments such as Adynovi—called Adynovate in the U.S.—going away anytime soon, though. As CEO Flemming Ornskov figures, they "will still be part of the treatment options for patients, and in many cases, the foundation of their treatment,” he said in a December interview.
That’s certainly what the big biotech is hoping. Shire’s playing catch-up in the hemophilia arena to companies developing market-changing gene therapies and bispecific antibodies, a status Ornskov blames on Baxalta being “a bit starved for resources and innovation” before the buyout.