MNTA: Quick notes (a compilation) from the CC today on Copaxone ANDA acceptance for review:
M356 (Copaxone generic) was filed by Sandoz on Dec 27, 2007.
They are not sure if they are "first to file." Yet. However, it seems obvious that they are.
MNTA/Sandoz believe TEVA's 7 Orange Book patents are invalid or not infringed upon.
Believe that OGD at FDA will prosecute this application, just like they did generic Lovenox.
Regarding the perceived possibility of clinical trials: This is the same path as a 505(j) filing; i.e., no trials are normally requested.
Craig Wheeler feels that the current biologics legislation does not affect the Lovenox/Copaxone apps.
Will not disclose EU plans for Copaxone.
50/50 profit split with Sandoz regardless of other entrants; no constraints. This 50/50 profit split applies throughout the world, not just in the US.
MNTA pays up-front for process-development expenses and NVS pays up-front for commercialization expenses; however, expenses incurred by either partner in this regard will be “trued up” to arrive at the 50/50 profit split.
Believe they have a scalable manufacturing process for Copaxone in-place.
If tentative approval is not garnered by June 2010, 180-day exclusivity would be lost unless any delay was caused by the FDA for any reason, such as a request for more data.
"Illegitimacy is something we should talk about in terms of not having it."
- Dan Quayle
