Biotech Values

[DewDiligence]

MNTA: Teva’s Bill Marth ought to have his title changed from CEO of Teva North America to Minister of Propaganda.

I previously cited Marth’s bogus Copaxone mathematics in #msg-45378265, but Marth’s comments vis-à-vis Lovenox are even more disingenuous, IMO. From the blog you posted:

…with Lovenox, the active sequence has been identified by us. It has been identified by the innovators. It has been identified of course by Momenta and Amphastar. So it is defined. It is a sugar. When you look at those sugars and you look at the active sequence, then what you really have to do is understand what is the other stuff or junk that is within your protein or sugar, and there make sure that you don't have improper immunogenicity. They have asked us for immunogenicity testing. We have done that. And it seems to be acceptable so far.

Marth neglects to mention that branded Lovenox has many constituents aside from the heparin chains that inhibit FXa and FIIa. This is a convenient omission insofar as Teva has not been able to characterize what these other constituents of Lovenox are—but MNTA has. Hence, Teva argues in its Citizen Petition to the FDA that comparable FXa/FIIa inhibition to branded Lovenox ought to be all that’s required of a generic. Meanwhile, SNY and MNTA assert that full characterization of all of the constituents of branded Lovenox is the proper requirement for an approved generic.

Whether the FDA approves a sole generic or multiple generics hinges on where the FDA stands on this point.