Biotech Values

[DewDiligence]

Why Teva won’t get FDA approval for Lovenox:

I recently reread my own post in #msg-45522123 and I see that it has the smoking gun vis-à-vis Teva’s lame attempt to copy Lovenox. Here is the relevant passage, which is a direct quote from Bill Marth at the Goldman Sachs conference on 8-Jan-2010:

“...with Lovenox, the active sequence has been identified by us. It has been identified by the innovators. It has been identified of course by Momenta and Amphastar. So it is defined. It is a sugar. When you look at those sugars and you look at the active sequence, then what you really have to do is understand what is the other stuff or junk that is within your protein or sugar, and there make sure that you don't have improper immunogenicity.”

Bill, the “other stuff” in Lovenox that you speak of is not necessarily junk; to the contrary, it may have physiological activity that is not well understood.

If you have not characterized the Lovenox junk, then you have not replicated Lovenox and your drug is not the same as Lovenox. That’s why you have not gotten FDA approval even after eight years.

Sorry, Bill—your ItalFarmaco gambit may have been a reasonable thing to do in 2003, but it doesn’t cut it with the FDA and I think you know that already.