Momenta Pharmaceuticals, Inc. (MNTA)

Deutsche Bank BioFEST

December 05, 2011 9:00 a.m. ET

Executives

Rick Shea - SVP and CFO

Ganesh Venkataraman - CSO, SVP, Research and Co-Founder

Analysts

Robyn Karnauskas - Deutsche Bank Securities

Presentation

Robyn Karnauskas - Deutsche Bank Securities

Thank you all for joining us and for those of you on the webcast. I am Robyn Karnauskas. And next, we have Momenta Pharmaceuticals. And it’s my pleasure to introduce, not only Rick Shea, the CFO, but also Ganesh Venkataraman – did I say that correctly – which is the one of the founders and chief scientific officer of Momenta.

And actually for those of you who are listening on the webcast, if you want to email me any questions, robyn.karnauskas@db.com. So with Ganesh here, he could answer any questions around their acquisition this morning and around some of the science behind Momenta.

And for those of you in the audience, again, we’re trying to use the DB app to sort of get some real-time feedback on the conference.

So with that, we’ll start off talking about – talking about Lovenox, first of all. You guys have been very successful with defending your patents. Maybe talk a little bit about -- you've got several cases actually ongoing. Maybe just give everyone in the audience an update on when is the next data point for each of those court cases? When we’re going to hear.

Rick Shea

So as you know we have been – in response to Amphastar’s approval for generic Lovenox on September 19, we sued Amphastar and Watson under our patents and obtained initially a temporary restraining order and then a temporary injunction against Amphastar and Watson, preventing them from launching.

Amphastar and Watson have appealed both at the district court level on emergency basis as well as at the appellate level, both on emergency basis and on a protracted basis. And as of last Friday, the district court upheld the original temporary injunction, denied the motion by Amphastar.

So Amphastar’s avenues of ending the temporary injunction now lie with the appellate court. There are some briefs and documents that are to be filed at the appellate level during the month of December and into early January. So sometime following that, presumably that there will be some hearing at the appellate level and some determination by the appellate court of whether the temporary injunction will stay in place.

Robyn Karnauskas - Deutsche Bank Securities

And TIs are very hard to get and they are hard to overturn, do you have a statistic on what percentage of TIs that are overturned at the appellate court?

Rick Shea

I don’t have a statistic, and I find when applying general industry wide statistics to whatever is happening at Momenta is probably a bad analogy.

Robyn Karnauskas - Deutsche Bank Securities

Very fair. And then I get some questions sometimes about people thinking you can manufacture a drug ex-U.S. and import it. But it wouldn’t infringe International Trade Commission rules, you can file suit under ITC and keep that from happening, as well as you can’t leave away anywhere (ph).

Rick Shea

Yeah, you are referring to our similar lawsuits on the patents against Teva Pharmaceuticals, for their generic Lovenox. In their early response to that suit, they’ve indicated that they are manufacturing the drug offshore and that might possibly be a vehicle for defense for them. And I think you’re absolutely correct that using an infringing process to manufacture a product and then importing that into the United States, this is not allowed. And so their argument would have to be slightly different, a more subtle argument, than simply the fact that it’s manufactured offshore.

Robyn Karnauskas - Deutsche Bank Securities

If that would happen, would you have to go through a separate court through the ITC to sort of – because there is better rules against that, via ITC court case versus the U.S. court?

Rick Shea

My understanding is that we can use the court process for that.

Robyn Karnauskas - Deutsche Bank Securities

Okay. And then third on the sanofi – the case against sanofi, maybe remind the audience what the case is versus the sanofi. And they recently made a decision to remove their authorized generic, I think that was last week. Maybe talk a little bit about what’s the status on the court case, first of all and then –

Rick Shea

Well, the court case with sanofi is not versus Momenta. Sanofi sued the FDA on the basis that the FDA’s approval – rejection of their citizens' petition and approving their generic Lovenox. So we are not a party to that case. My understanding is that, just following the normal course of litigation, which in this country, once their request for a preliminary injunction was denied, can easily take a couple of years or so. And I don’t see anything that is happening to make that move more quickly.

Of course, in response to Amphastar’s approval and their announcement – Watson’s announcement that they were going to launch in the fourth quarter, sanofi, through their subsidiary, Sanofi Winthrop, did launch an authorized generic. You can see in the court papers that were filed in the Amphastar case that there are declarations from Sandoz regarding that launch and what Winthrop has been doing. So Winthrop went after several of Sandoz’s customers, it was clear that they secured at least one of those customers. And in response, Sandoz had to make some price reductions to some of their retail customers.

Read the rest of this transcript for free on seekingalpha.com

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