Yes, CSL’s FVIIa-albumin conjugate is made in cell culture, which leads one to wonder how the yield—and the manufacturing cost—will compare to NovoSeven’s.
There’s also the question of how much like NovoSeven this product will be in terms of efficacy. Note the use of waffle words in the abstract:
“The recombinant FVII albumin fusion protein was expressed in mammalian cells and upon activation displayed a FVII activity close to that of wild type FVIIa.”
…and also in the PR:
“…rVIIa-FP demonstrated a biologic activity comparable to wild type rFVIIa.”
Moreover, it looks as though CSL has reduced the upper bound of the range of increase in the half-life relative to NovoSeven. In the PR from Dec07, the range was given as 6-9x, but in the abstract it is given as 6-7x.
Whether albumin conjugation turns out to be a better approach to extending FVIIa half-life than PEGylation—the approach being used by NVO/NTEC and by Omri Labs in Israel—remains to be seen. Further, it remains to be seen whether any of these attempts to modify endogenous FVIIa will lead to safety issues.
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