Biotech Values

[DewDiligence]

Re: Lovenox ANDA from HSP

>At least four companies have filed ANDAs with Paragraph IV certification for generic versions of Lovenox (enoxaparin sodium): Teva, Amphastar, MNTA/Sandoz, and Hospira.<

Was the HSP filing disclosed very recently? I see that the FDA lists one of the Lovenox ANDA’s with a filing date of 12/7/06 and I presume that one is HSP’s:

http://www.fda.gov/cder/ogd/ppiv.htm

If the HSP ANDA was only recently disclosed, it means that the ANDA was only recently accepted for review. Hence, it may be too early in the review for anyone to get a read on it.

I would think that HSP lacks the in-house expertise to characterize and reverse-engineer a drug as complex as Lovenox, but I could be wrong about this. My first reaction to your post is that HSP has licensed the US rights to a Lovenox knockoff developed by another (presumably foreign) company.

I’d appreciate hearing any further comments you may have on this matter. Regards, Dew

p.s. Why does the FDA document referenced above list only three P-IV challenges rather than four?