Biotech Values

[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?