Replies to post #89042 on Biotech Values

[DewDiligence]

TEVA MNTA: Michael McCaughan, author of the blog you posted, is off-base, IMO, to, call Teva’s position with respect to Lovenox and Copaxone a hedge. From the same blog:

So call it a hedge: if generic Lovenox is rejected, Teva’s Copaxone franchise is more secure.

This is a weak premise. The one thing Bill Marth said in the quotations cited by the blog that I would not characterize as BS is that Lovenox and Copaxone are very, very different compounds. I don’t think the FDA’s ruling on Lovenox will be strongly indicative of how the FDA will rule on Copaxone.

[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.

[genisi]

Quiz: The blogger made a spelling error that stands out. What is it?

[jq1234]

“When you think about Copaxone, many people try to equate it to Lovenox. It is much, much different—vastly more complex—than Lovenox will ever be. We have not characterized it. We don't believe it can be fully characterized."

Maybe indeed Teva's capability of full characterization isn't that great.