New Roche threat to Shire's hemophilia franchise? CEO Ornskov says he's not worried

Blood
Shire has new hemophilia competition from Hemlibra, a new product from Roche's Genentech that analysts have dubbed a future blockbuster.

ATLANTA—Roche’s Genentech is out with a new threat to Shire’s hemophilia franchise in the form of a bispecific antibody dubbed Hemlibra—but the Dublin drugmaker’s CEO, for one, says he is not too concerned.

“I don’t think factor VIII, I don’t think factor IX, I don’t think plasma, I don’t think Feiba is going to go away with any of the things I see here,” Chief Executive Flemming Ornskov said in an interview at the American Society of Hematology (ASH) annual meeting. Those older therapies "will still be part of the treatment options for patients, and in many cases, the foundation of their treatment,” he said.

RELATED: Single-minded Shire finally pins down Baxalta with $32B deal

That’s the outcome Shire needs, at least. Currently a front-runner in hemophilia because of its Baxalta buyout, Shire lags a few years behind some of the leaders in potentially disruptive fields such as gene therapy and bispecific antibodies. That's because Baxalta "had been a bit starved for resources and innovation” before Shire snapped it up, Ornskov said.

Since then, Shire has done what it can to correct course. It licensed in a bispecific antibody and sped up “all the things that we can do in gene therapy,” Ornskov said. “I think we’ve shown in multiple categories that we can catch up and sometimes overtake some of our competitors," he said.

For now, though, it’s Roche that has the bispecific antibody lead—and the threat to Shire’s market share—with Hemlibra, a product that snagged approval last month in hemophilia A patients who have developed factor VIII-inhibiting antibodies. Hemlibra put up positive longer-term data at ASH, and consensus estimates peg that product at $2 billion in sales by 2025. Some analysts, such as those at Jefferies, think it could pull in much more if it can move into the larger, noninhibitor population.

RELATED: Roche nabs blockbuster FDA approval for Hemlibra, big label expansion for Gazyva

But as Ornskov cautioned, while there’s “significant unmet need” in the inhibitor group and “doctors are really welcoming” of another treatment option, they may not be as keen to use Hemlibra in the noninhibitor population, which represented “a more satisfied market.”

“The hurdle both safety-wise and in terms of efficacy is pretty high in that area, so any new agent will have to meet this criteria,” he said, adding that “the unmet need, I’m sure, is also there, but it’s not of the same magnitude.”

What if Hemlibra can snag a green light and manage to poach market share, though? Shire will still be okay, he insisted.

“Hemophilia is 20-plus percent of our business. It is not our largest business,” he said, noting that distinction “by far” belongs to immunology. Still, when it comes to hemophilia, “I feel very confident that with the right investment, the right focus, with the new R&D team that I’m putting in place, that we will do very well and continue to be a leader,” he said.