Momenta Pharmaceuticals, Inc. Q3 2009 Earnings Call Transcript

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2009-11-06 01:30:20.0

Tags: FDA, Oppenheimer & Co., Call Transcript, Earnings, Question, Momenta Pharmaceuticals Inc., Federal Government, Healthcare Reform, Government, Healthcare, Seeking Alpha

Question-and-Answer Session

Operator

(Operator instructions). Our first question comes from Bret Holley.

Bret Holley – Oppenheimer & Co.

Yes. Thanks for taking the questions. I’m wondering just kind of the 30,000 level, if you think the pending healthcare reform legislation adequately addresses the difference in biogenerics and biosimilars. It seems like there is often a completion of these concepts in the legislation in my mind?

Craig Wheeler

Yes, Bret, thanks. I think you're correct. There still continues to be confusion among the use for the works of biogeneric and biosimilars etc., I think the thing that really gives us confidence that we can adequately address that is that it does give the ability to the FDA to actually make substitutable decisions. And so, while the Nomenclature continues to be confused I think in various different bills and conversations, the statutes that we see being developed there are very clear at least at this point that the FDA has the discretion to actually allow for the approval of substitutable drug.

Bret Holley – Oppenheimer & Co.

Okay. So basically just the interchangeability is kind of left to the discretion of the FDA, you’re confident that based on their scientific understanding, they can adequately make a decision essentially for the legislators?

Craig Wheeler

Yes. We do believe that is the intent and that will happen that way

Bret Holley – Oppenheimer & Co.

Okay. And then the other question I have was what the potential time line following the Markman hearing will be in the generic Copaxone litigation, just I guess theoretically what next steps would be?

Craig Wheeler

Well, I think it’s really hard to speculate because a lot of that depends upon how narrow the scope of the claims are, that are defined. Of course, we’re going to a trial phase after that and a lot can happen around the Markman hearing. I mean you would expect that it should be able to be completed with the timeline so advance for the Markman hearing within the stay before 2011. So I would estimate that we would be able to be done before them, but speculating on a specific timeline probably doesn’t make sense.

Bret Holley – Oppenheimer & Co.

Fair enough. Thanks for taking the questions.

Craig Wheeler

Sure. Thanks.

Operator

Our next question comes from Eric Schmidt. Please state your question.

Eric Schmidt Cowen & Co.

Good morning. Craig, just a further probe little bit on your comments about the USP standards changing for Enoxaparin on December 1. Do I interpret what you said to me that you could in fact be approved even before the December 1 change?

 

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