Replies to post #107438 on Biotech Values

[DewDiligence]

RockRat et al: What prompted this thread in the first place was not merely piecing together some circumstantial evidence; rather, I have a credible source who asserts that the drug in Teva’s ANDA is the Lovenox knockoff developed and manufactured by ItalFarmaco. Regards, Dew

[ilpapa]

all we have in the public domain is ItalFarmaco's status as the producer of Lupenox whose facilities have been inspected by the FDA in September of 2010. A small amount of circumstantial evidence, at best.

I still think it's hardly credible that TEVA would foist Lupenox on the FDA as a fully characterized Lovenox, but I'd say it was strong circumstantial evidence that Italfarmaco are producing whatever TEVA is showing the FDA. It may not be Lupenox, however, but something a whole lot closer to the FDA's criteria. That's my worry.

[genisi]

Regardless of the information from Dew's source, which I will try to inquire about after Teva will report 3Q10 next week, I think the answer to the question - can Teva's ANDA for generic Lovenox pass the high bar placed by Momenta, is - no. And if it takes few more years, as I suspect, Teva might withdrawal.