Kovaltry (Bayer) is a full-length recombinant factor VIII (rfVIII) protein that has been manufactured without using human- or animal-derived proteins throughout the manufacturing process. As a follow-on to Kogenate, Kovaltry is produced using technologies that improve consistency in glycosylation and expression, resulting in a purer product with low levels of protein aggregates. Unlike other recent hemophilia approvals, Kovaltry does not offer any major pharmacokinetic differences or an extended dosing interval frequency compared to its predecessor therapy. Rather, Kovaltry was approved in early 2016 with dosing of two or three times weekly.
Kovaltry falls outside of the prior commercial agreement between Bayer and CSL Behring pertaining to the marketing of Kogenate (rfVIII; Bayer/CSL Behring). As such, Bayer holds exclusive rights for the development and commercialization of Kovaltry.
LIST OF FIGURES
9 Figure 47: Xyntha for hemophilia – SWOT analysis
11 Figure 4: Hemophilia market sales across the US, Japan, and five major EU markets, by indication, 2016–25
13 Figure 5: Hemophilia sales across the US, Japan, and five major EU markets, by treatment strategy, 2016–25
LIST OF TABLES 6 Table 1: Kovaltry drug profile
14 Table 2: Kovaltry sales for hemophilia across the US, Japan, and five major EU markets, by country ($m), 2016–25
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