GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Maxygen MAXY-Seven (rFVIIa) update:

Now that Roche has dropped out of the development program for MAXY-Seven (#msg-17854630), MAXY will no longer pursue acute bleeding conditions as an initial program goal. Instead, MAXY says it will focus on hemophilia and will file an IND to begin phase-1 in 1H08.

MAXY’s stated reason for dropping the acute settings from the development program is that the regulatory path for these indications is unclear. (Roche had previously cited the lack of a large-animal model for acute bleeding conditions as a significant impediment.)

Despite the talk of a strong commitment to a scaled-back MAXY-Seven program, I foresee the program’s getting squeezed by MAXY’s budgetary constraints and proceeding slowly, if at all. Moreover, for the reasons mentioned in #msg-17854630, I question the need for an “enhanced” rFVIIa product. Evidently, Roche does too.