- Shire plc has gained European approval for one of its key hemophilia drugs. But the victory will likely be short-lived, as analysts still expect a substantial portion of patients with the blood disorder to switch over to treatment with Roche's Hemlibra.
- The European Commission OK'd Adynovi — marketed as Adynovate in the U.S. — as an on-demand and prophylactic treatment for hemophilia A patients 12 years and older. According to a Monday statement, the EC's decision hinged on positive data from three late-stage trials.
- Investment bank Cowen & Co. estimates international sales of Adynovate totaled $20 million in 2017, and will rise to a peak of $110 before falling due to competition from Hemlibra.
Shire's latest approval comes as it braces for substantial losses within its hemophilia business. The Irish drugmaker expects new therapies, such as Hemlibra (emicizumab), to erode about half of its Feiba (anti-inhibitor coagulant complex) franchise by 2022.
Hemlibra is indicated for hemophilia A patients with inhibitors, putting it in direct competition with other inhibitor-centric products like Feiba. Where Roche's drug really stands apart, though, is in its its once-weekly dosing regimen, which is much less frequent than competitor products.
Hemophilia drugmakers are already wary of the threat Hemlibra poses to their bottom lines, and are working to progress their own even longer-acting therapies to market.
Yet those companies will also need to keep an eye on their non-inhibitor products, according to Cowen analyst Ken Cacciatore.
The investment bank recently surveyed 25 hemophilia experts who collectively treat 954 hemophilia patients, and found that, while many are waiting for more safety data and regulatory progress before prescribing Hemlibra to non-inhibitor patients, Roche's drug is poised to steal a good amount of those patients in the next several years.
"While these two requirements are likely to be met in due time, other clinicians indicated that stability of patients on their current treatments also represented a barrier," Cowen analyst Ken Cacciatore wrote in a Jan. 8 investor note. "And as anticipated, clinicians anticipate a slower uptake in non-inhibitor patients following approval, with 12% of their patients expected on Hemlibra within 6 months, and 31% expected on the drug within 3 years."
Cowen estimates Shire's non-inhibitor product revenues will hit $2.92 billion in 2018, but will fall to $2.55 billion in 2020 as Hemlibra makes headway in the market.