Biotech Values

[DewDiligence]

MNTA: to what extent, if any, are you concerned that the FDA might ultimately ask MNTA/NVS to run clinical trials to compare its generic lovenox to the branded version?

This is a low-level concern, IMO. By statute, ANDA’s require a showing of bioequivalence to the branded drug, and NVS/MNTA have already shown that. The FDA has never requested independent confirmation of a generic drug’s safety and efficacy; indeed, such a request would negate the premise of the Hatch-Waxman act that created the ANDA regulatory pathway in the mid 1980’s.

This is not to say that an FDA request for a new clinical study is impossible, but I think it’s sufficiently unlikely to be of little practical consequence. A bigger concern for MNTA investors is that the FDA might approve the competing ANDA’s from Teva and/or Amphastar in addition to the ANDA from NVS/MNTA.