Replies to post #62077 on Biotech Values

[DewDiligence]

Re: Sole vs multiple Lovenox approvals

>MNTA – one of the interesting questions remaining open is whether FDA has provided parallel guidance to Teva and/or Amphastar.<

From Teva, we can expect a no comment unless/until they have positive Lovenox news; hence, no news from Teva ought to be good news for MNTA shareholders.

For Amphastar, we have to rely on WPI to disseminate news. Any correspondence from the FDA on Lovenox is arguably a material event for WPI, so there’s a decent chance we’ll learn at least the rudiments of what is going on.

[stockdak]

MNTA--From the last CC.

<Q – Michael King>: Okay. And then final question is regarding the 180-day clock. That presupposes that Amphastar was first to be declared, first to file. But how do you view --I know
there has been some discussion about who’s really considered first to file, as the FDA may not view the Amphastar or the Teva application as complete. So I am just wondering if there is really any upside to that post the Appeals Court decision.

<A – Craig Wheeler>: Yeah, there is always the possibility there, but I think we have not put a firm stake in the ground on who is first. We know there are multiple players out there and we know that it could be a little messy, but our anticipation from the legal side is that even you had a different multiple patents out there that both of those patents will be covered in whatever decision is coming down on the legal side. So we think the starting of the clock would be a very good thing for us; any of those alternative outcomes could be even better for us.

<Q – Michael King>: Well I would imagine the FDA would have to make that decision at that time, wouldn’t they, as to who would --who is actually the first to file?

<A – Craig Wheeler>: Let me ask Rod Riedel, our Vice President of Regulatory to shed some light on that.

<A – Gerard Riedel>: Yes, this is Rod Riedel. The FDA will make a determination about first to file whether it’s a sole company or it’s shared on the basis of the time that that particular application is ready for final approval. I think you have raised a very interesting potential scenario, which is if the
court decision comes down and starts the 180-day exclusivity clock, what happens if the first-to-file applicant is not ready for approval. And from our perspective it starts the clock. The clock starts with the district court decision, because this application was filed before the MMA changes to the 180-day exclusivity. So it’s a very interesting position, and then it gives us a strong incentive to resolve these issues as quickly as possible, so that we are --we will be ready as early as we
possibly can.

[ThomasS]

MNTA: Your question may be more difficult to answer than you think. "Parallel guidance" from the FDA implies parallel input from Teva/Amphastar, in the context of what MNTA stated today:
"...Momenta and Sandoz submitted a proposal to FDA for addressing the potential immunogenicity of M-Enoxaparin, in response to FDA's letter of November, 2007. On April 28, 2008, FDA responded to the proposal and provided additional guidance which indicated their general concurrence with the Company's approach and proposal. FDA also requested additional data from in vitro and in vivo animal tests, the testing of additional samples for tests previously proposed, and additional information regarding certain of the methods proposed."