Biotech Values

[DewDiligence]

MNTA: I’m going to go out on a limb and propose that the FDA’s response to Teva’s Copaxone Citizen Petition is neutral or even slightly bearish for MNTA. The overall tenor of Janet Woodcock’s letter to Teva (excerpted in #msg-50149604) is that the FDA is setting a relatively low bar for the definition of sameness. A relatively low bar for sameness increases the likelihood of multiple FDA-approved generics for Lovenox, which decreases the probability of the best-case scenario for MNTA (a sole FDA-approved generic Lovenox).

The FDA’s response to Teva’s CP does, of course, make eventual FDA approval of MNTA’s generic Copaxone more likely.* However, from a valuation standpoint, this is offset or even outweighed (IMO) by the slightly reduced likelihood of MNTA’s having a sole FDA-approved generic Lovenox.

*I especially like Dr. Woodcock’s rebuttal of Teva’s chutzpah in comparing Copaxone (a synthetically produced polypeptide) to Premarin (a biologic).