Replies to post #111410 on Biotech Values

[tinkershaw]

According to Teva, the FDA said it is not completely clear how Copaxone works, so the agency cannot be certain the new version would be as effective.

I would much rather read what the FDA actually said. Funny how what the FDA said is exactly what Teva has said in its citizen petitions that the FDA has rejected on multiple occasions.

As with lovenox, in which it is not clear at all how all the supposed "junk" works (which is all that TEVA has stated it needs to work on) the FDA nevertheless allowed mlovenox on the market as identical without having to run a clincal trial. This is because what MNTA submitted was proven by MNTA, in a manner acceptable to the FDA, that it was identical, and therefore knowing the mechanism of action is irrelevant as identical is identical.

It is part of Teva's very tortuous web of spin however.

Tinker

[DewDiligence]

Two points:

• NVS/MNTA’s ANDA is not seeking approval for a formulation change to Copaxone; to the contrary, NVS/MNTA’s version of Copaxone is a reverse-engineered replica of Teva’s branded Copaxone that will likely have less variation from a given lot of Teva’s Copaxone than two lots of Teva’s Copaxone will have from each other.

• The language in today’s Teva PR about Copaxone’s MoA emanated from Teva, not the FDA.

Regards, Dew

[jq1234]

I can't understand how the FDA's statement on low volume Copaxone won't impact MNTA's generic approval.

1. FDA was talking about sNDA here, not ANDA. NDA and ANDA have completely different standards.

2. Teva applied "for its supplemental New Drug Application (sNDA) for a lower-volume (0.5mL) injection of glatiramer acetate. Copaxone® containing 20mg of glatiramer acetate in 1ml is the global market leader in the treatment of relapsing-remitting multiple sclerosis (RRMS)." FDA deemed 20mg/1mL is different from 20mg/0.5mL from NDA point of view, so adequate clinical data are needed for approval.

3. MNTA ANDA is for generic version of 20mg/1mL.