MNTA / WPI / generic-Lovenox addendum:
Other than Sandoz/MNTA, the two other sponsors of Lovenox ANDA’s are Teva and Watson/Amphastar.
Teva is such a large company that non-approval of its Lovenox ANDA would not reach the threshold of materiality for investor disclosure, so we will not hear anything negative from Teva on this subject.
Amphastar is private and is the actual filer of the Watson/Amphastar ANDA, but Watson (WPI) is public and is just small enough that an FDA action on the ANDA might be considered material. By coincidence, WPI held its 3Q07 CC this morning and was asked about Lovenox. This is what was said at 28:58 into the call”
“Well… we read [MNTA’s PR] the same time you
did. We have not heard from out partner this
morning… they are of course on the West Coast. We
have a call in… if we hear anything we’ll certainly let
everybody know. But right now we’re just evaluating
the [MNTA] release that we saw and we’ll react to it
once we talk to our partner.”
This doesn’t exactly sound like a denial, IMO. (Elliot Wilbur of CIBC is the one who asked the question.)
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