Replies to post #107419 on Biotech Values

[RockRat]

With all due respect . . . Are you kidding me?

>>After reviewing the FDA's response to the citizen petition, which outlines 5 criteria to demonstrate "sameness", Teva believes that it has demonstrated to the FDA that its version of generic Lovenox meets their criteria and that Teva's pending ANDA is approvable. <<

This sentence sure reads to me that Teva believes it has met the 5 criteria. Yet you say:

"However, nothing in that statement is indicative of meeting the standards that the FDA laid out. NOTHING." Why does that seem to me to contradict your assertion that "Reading it in context of this Indian drug, yes, Teva was exactly accurate?"

In my opinion there is no way Teva can accurately say that Luponex meets the 5 criteria. I'm not a lawyer, but if they are really talking about unmodified Luponex when they refer to their version of generic Lovenox, this is close enough to a flat out lie to be actionable.

Regards, RockRat

[mouton29]

<<However, nothing in that statement is indicative of meeting the standards that the FDA laid out. NOTHING>>

I agree with your analysis of the second part of their comment but they do make the unqualified assertion in the first sentence that they believe they have demonstrated to the FDA that they meet the 5 criteria outlined by the FDA. They just don't back it up in the second paragraph.

[jb_118]

Teva maintains the approval for an ANDA for generic Lovenox is appropriate because:

...The active ingredient in enoxaparin is significantly better characterized than the active ingredients of significantly more complex molecules
- Pharmacologically active portions of enoxaparin can be identified and replicated, and
- In vitro and in vivo PD tests are rapidly indicative of drug efficacy and safety



This third point is funny in that (as I recall) the specific point of the SNY lawsuit against the FDA with respect to mEnox is that the in-vivo immunogenicity data was used by the FDA to show safety, which is against statue. FDA didn't dispute that would be against statue, but just stated they didn't use that data for safety/efficacy, but rather manufacturing purity. In this light, the SNY lawsuit might turn out to be more about keeping TEVA from getting approval than getting mEnox revoked.

TEVA could pull branded lovenox right off the shelf and not get it approved as a generic unless they are able to prove it is the same drug by some means other than in vivo testing. There are two hurdles here. 1) come up with a sufficiently similar drug; 2) show it is the sufficiently the same by means allowable by statue (i.e the same mix of molecules, not just similar efficacy which can't be an approval consideration in the ANDA mechanism).

At this point i'm not sure they've done either one.

[iwfal]

MNTA - A move away from Clintonian parsing of conference calls -g-:

TEVA, in their PR after m-enox approval, clearly fired off a rationale as to why meeting the 5 sameness criteria for a Copaxone generic is, in their opinion, impossible:

- The active ingredient in enoxaparin is significantly better characterized than the active ingredients of significantly more complex molecules
- Pharmacologically active portions of enoxaparin can be identified and replicated, and
- In vitro and in vivo PD tests are rapidly indicative of drug efficacy and safety

I am not smart enough in chemistry to comment on number 1 of this list, but number 2 and 3 actually seem reasonable assertions, if a little sloppy in their exact representation of the FDA criteria. For instance, the FDA required for enox that the applications show in vitro and in vivo assays that demonstrate sameness of efficacy profile. In the case of enox that was (potentially among other things) the proper values/ratio of the two primary modes of action for enox (anti-Xa and anti-IIa). But since no one knows with much certainty the different modes of action for Copaxone how is this condition to be met for a g-Glat submittal?