Momenta Pharmaceuticals, Inc. (MNTA)

[RockRat]

"it means MNTA's lead over MYLAN has likely been wiped out"

I hear you, but I think you put too much weight on the possibility that Mylan can get approval for their generic Copaxone. This is where MNTA HAS delivered. Note that Teva, using Lupin/ItalFarmaco's enoxaparin knockoff, has gotten nowhere with this enoxparin with the FDA, despite a two year head start (I think it's been 9 years). Similarly, I think you can expect Mylan to have regulatory problems with their Copaxone knock-off produced by Natco of India. This version is approved in Ukraine and maybe one other piddly country. That should tell you something.

I grant you, virtually no one, including me, thought Amphastar could get approval, either, but they were not working with a foreign knock-off that has yet to see approval in a first world country.

No doubt the legal loss hurts. If one thought MNTA had even odds of prevailing at the district level, one would have to give less than even odds of winning on appeal. That describes me, so I am resigned to MNTA launching no earlier than 9/14. I see a slightly better chance of getting a partial appeal victory in the form of getting the process patent overturned, so that they aren't shut out till 2015.

And maybe this means MNTA's enoxaparin process patent is strong enough to win that revenue stream back. My expectation of that outcome has improved slightly, though there's probably little basis for it, since there are some differences in the legal setting aside from the patents themselves, as has been noted. We'll have a much better idea about that when we see the opinion regarding the lifting of the injunction. Geez, that's taking a long time to write!

Regards, RockRat