Biotech Values

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"So I think what we are left with is can Teva characterize in this manner?"


I think we need to step back and look at Teva's original PR on July 23 for some key words.


JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA - News) commented today on the U.S. Food and Drug Administration’s response to a citizen petition questioning the approval criteria for a generic Lovenox® (enoxaparin sodium) injection and its subsequent approval of another generic filer’s Abbreviated New Drug Application (ANDA).

After reviewing the FDA’s response to the citizen’s 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.

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

If they did file a new ANDA for Lovenox in 2008 it appears that they are still not confident it has been fully characterized.