Haven't you been following all the convolutions at IHub?
The last time a molecular weight for Lupenox was published was in early '08, which means it was actually measured in '07. One theory is that since then, changes have been made to Lupenox, but the changed product is still being marketed under that name, and this is what is currently being presented to the FDA. The apparent involvement of some Italian third party does point to ItalFarmaco being involved. The other theory is that if it is the original Lupenox, it does not infringe, and Momenta won't prevail in the lawsuit. But they'll prevail in the marketplace because T-enox wouldn't get approved.
The earliest of the two patents issued in August of '09. If the FDA made it obvious that Lupenox 1.0 was not going to fly in late '07 by demanding immunogenicity data, that would have given Teva about a year and a half to change w/o infringing. That's a WAG. FDA might have pointed to the molecular weight disparity earlier than that.
As all of you know, I've never been in the camp that Lupenox 1.0 is T-enox, and I was skeptical ItalFarmaco was involved at all. Since an Italian 3rd party is mentioned in the motion for summary judgement documents, I am less skeptical of ItalFarmaco's involvement, but maintain that T-enox is Lupenox 2.? or something entirely different, with odds heavily favoring the the latter (see below for why). I've mentioned that I did an IP search of ItalFarmaco and found their IP related to heparin only involves filtration, not any novel process for depolymerizaton. This may explain why Lupenox 1.0 weighs ~20% less than enoxaparin. Finally, an email communication by Teva's IR to an IHub poster said that Teva was "very pleased with our partner for generic Lovenox." Implying there is only one. An ex Teva exec -- a commercial development veep or someone of that ilk -- joined ItalFarmaco shortly before the filing of the Teva enoxaparin ANDA.
OTOH, idos posted that she had an analyst ask Teva if T-enox was Lupenox and the CFO said it was different than the drug marketed by Lupin.
siliconinvestor.com
Cheers, Tuck |
