Biotech Values

[DewDiligence]

Miscellaneous items from MNTA’s 4Q13 CC:

• M923* (the lead FoB compound in the BAX-MNTA collaboration) will start phase-1 in the EU rather than the US. According to Craig Wheeler, the rationale for starting in the EU is timing; specifically, the FDA requires a full-fledged clinical roadmap to begin even a phase-1 trial under the 351(k) pathway for FoB’s, while the EU does not. MNTA expects to conduct a global clinical-trial program for M923—including the US—once the phase-1 PK data are in hand; however, the degree to which the global clinical-trial program can be abbreviated relative to a conventional (i.e. non-FoB) clinical-trial program remains to be seen. My take is that the FDA staffers who provide guidance on the 351(k) pathway are not up to speed vis-à-vis MNTA’s characterization and reverse-engineering technology for biologics.

• MNTA has decided to develop a recombinant form of IVIG using the Fc components rather than a plasma-derived variant of IVIG per se.

*Probably Humira—see #msg-97084466.