Replies to post #11427 on Momenta Pharmaceuticals, Inc. (MNTA)

[nu123]

thanks, jbog.
I think it is more positive than if it fails. This result at least proves TEVA's claims were wrong. Copaxone is not hard to copy. At least 3 companies have done that. FDA will approve all of them before the end of 2015.
From last cc, CW commented that Synthon followed EMA rule to do p3, it may not be accepted by FDA.
Another thing is that, MNTA ANDA is different pathway from Synthon ANDA. Synthon was late to the party in 2011, in order to get a piece of pie, it tried to short-cut by clinical trials which FDA does not require.
MNTA may slide further until TEVA's appeal result.

[pollyvonwog]

Notes from Ritu Baral (Canaccord) on Synthon

Synthon Copaxone-Like Drug May See 2015 EU Approval: Canaccord
2014-03-28 13:21:37.407 GMT

March 28 (Bloomberg) -- Synthon’s Phase 3 Gate study
showing equivalent efficiacy and safety of its glatiramer
acetate to Copaxone, has clear potential and timelines that may
lead to late 2015 EU approval, Canaccord analyst Ritu Baral said
in note yday.
* Canaccord believes Synthon has had L-T dialogue w/ EMA
around design, conduct of Gate trial which should
“translate” to high chance of timely approval
* Path forward in U.S. less clear as FDA review continues,
although Synthon confident of near-term approval
* Synthon’s strategy for U.S. most likely to impact for
Momenta and Sandoz partnered M356 generic Copaxone
* Synthon hasn’t had any real discussions w/ FDA around
application, development strategy, which is now even more
challenging given structured communications mandated by
Gdufa
* Canaccord expects full data expected to be presented at
ECTRIMS 2014 (Sept., Boston)