Kogenate (recombinant factor VIII [rfVIII]; Bayer/CSL Behring) – is a recombinant antihemophilic factor indicated for the control and prevention of bleeding episodes, perioperative management, and for routine prophylaxis in children and adults. Kogenate is produced using the baby hamster kidney cell line. Although the cell culture medium used in the manufacturing of Kogenate does not contain any proteins of animal origin, the cell culture medium does contain human proteins. The current formulation, Kogenate FS, is formulated with sucrose and has been available since 2000. This makes it a second-generation rfVIII, while the original therapy contained human albumin as a stabilizer and was thus initially classified as a first-generation recombinant product
Under an agreement that involved global distribution through 2017, Bayer distributed Kogenate to CSL Behring, which additionally markets it under the tradename Helixate in the US. In Europe, Bayer and CSL Behring market the product under the tradename Helixate NexGen. However, the manufacture of the Helixate brand is now being stopped and the product phased out, as CSL Behring transitions its patients onto Afstyla (single-chain rfVIII; CSL Behring).
LIST OF FIGURES
9 Figure 1: Kogenate for hemophilia – SWOT analysis
10 Figure 2: Datamonitor Healthcare’s drug assessment summary of Kogenate for hemophilia
11 Figure 3: Datamonitor Healthcare’s drug assessment summary of Kogenate for hemophilia
13 Figure 4: Kogenate sales for hemophilia across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES
6 Table 1: Kogenate drug profile
7 Table 2: Kogenate pivotal trial data in hemophilia
14 Table 3: Kogenate sales for hemophilia across the US, Japan, and five major EU markets, by country ($m), 2016–25
This is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.