Biotech Values

[acgood]

TEVA CFO on 12/7 webcast:

Re MNTA lawsuit:
"we don't understand what it means"
"baseless"
"meaningless"
"filed now because approval imminent"

Re tEnox:
They understand from FDA that nothing is holding up approval except for the process. No unanswered questions.

Re Copaxone:
-According to FDA, chemical sameness determination depends on knowledge of the mechanism of action (where do they get this idea? from the lovenox guidelines?). Since copaxone and some other biologics have unknown MOA, must do trials.
-If copaxone was filed today, would be filed as biologic (I am quite positive, based on lectures I attended recently, that this statement is absolutely false)
-Teva thinks the FDA "sees eye to eye with us" on these matters
-Reiterated no lawsuit case before 2012 probably
-He finally called the 0.5mL copaxone a "lifecycle" tactic, then quickly threw in a comment about being intended to ease patient comfort level
-Also used the request for clinical trial of 0.5mL formulation as evidence that generic will require trials
-Said Teva does not expect approval on 1/1/2011