Replies to post #107427 on Biotech Values

[zipjet]

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.

I can almost hear them saying, we explained exactly why we thought we met the FDA criteria for approval. We told you exactly what we had done and that it meets the criteria. Apparently the FDA did not agree.

:-)

ij

[iwfal]

MNTA TEVA -

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.

Not only don't they back it up, but the explanation is actually completely off topic - it isn't an explanation of why their generic enoxaparin is approvable, but just an explanation of why in their opinion a generic enoxaparin is possible but a generic Copaxone is not.

The active ingredient in enoxaparin is significantly better characterized than the active ingredients of significantly more complex molecules - nothing in here about how similar their enoxaparin is. Only how enoxaparin is more characterized than other products (hint, hint - Copaxone)

Pharmacologically active portions of enoxaparin can be identified and replicated - again, nothing about whether their enoxaparin is, in fact, replicating the branded version. Just another hint, hint about the difficulties of Copaxone.

In vitro and in vivo PD tests are rapidly indicative of drug efficacy and safety - again, nothing about their enoxaparin's results. Just another hint at the difficulty of generic Copaxone.

All in all, while the PR was ostensibly about defending the approvability of their enoxaparin, in reality is was explaining why they think they will maintain Copaxone without generic competition. An odd PR.