Biotech Values

[RockRat]

The Wall Street Journal, at least, has a well known source in a position to know about that issue. But, of course, this article does not directly address why Teva's ap is in limbo. Whether t-enox is Lupenox or something a little closer to branded Lovenox, it's the t-enox, not the bureaucratic bias, that's Teva's problem. It wouldn't be the first time the FDA moved the goal posts, but it is less usual for ANDAs; of course this ain't a small molecule . . . we can expect to see the FDA behave in this way in the future wrt biosimilars/FoBs. It'll frustrate all players, and will select for superior technique.

Anyhow, if the standards changed in '07 and Teva was actually trying to get approval for Lupenox, they probably started over shortly afterward. That'll be my belief until I can fiind credible evidence to the contrary. I still think the molecular weight issue would have made Lupenox a non-starter even earlier than that.

I wonder what will come out of the Amphastar suit. I think it will backfire on Amphastar. The FDA has been kind enough not to publicly say their version of Lovenox sucked, but Amphastar might just be forcing the FDA to do so under oath. We and the market might get a little color on how far off Momenta's competition is. But I'm clueless as to timing of the suit. The market may get other cues before then . . .

My premium gift subscription here expired today -- thanks again to my benefactor! So I'll just say that while I don't speak a lick of Italian -- do you? -- I've got cousins who speak it very well. We'll see what I can arrange, and if anything comes of it, y'all will be the first to hear about it.

Edit: we now have a link:

http://online.wsj.com/article/SB10001424052748703514904575602781097808598.html

Buona Notte, RockRat