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United Therapeutics' CEO Discusses Q1 2012 Results - Earnings Call Transcript

Martine A. Rothblatt

Okay, thank you very much. We're going to spend more through our time on your first question and you feel free to get back in the queue on the second question. Just to give you a quick answer, there is no change in our previously announced use of cash fund plans. Andy, can can you expand, provide some color on the IP questions asked?

Andrew Fisher

Sure. Thanks, Martine. So the situation with Tyvaso is that it has orphan drug exclusivity until July of 2016, and it has a range of Orange Book listed patents expiring from 2014 until 2018. So those are the things you need to be mindful of when you consider Tyvaso's exclusivity position with respect to generic filers. I would also remind our listeners that Tyvaso is approved as a drug device combination. So I think the situation presents slightly differently with Tyvaso, than with respect to the current pending Paragraph IV and the filing for a module.

Martine A. Rothblatt

Excellent observations Andy hopefully, that we're responses to Mark's question. I'd like to add just a little top off color, on top of that what Andy said. On the concept to the drug device combination because it's kind of an unusual concept in the biotechnology space. When we were originally getting the Remodulin approved the -- what was somewhat different is that the drug was improved with, sort of a generic step of infusion flow parameters that applied through the Medtronic, and formerly called MiniMed device, that infused it such that one could in fact, provide Remodulin with an -- the equivalent infusion device from another manufacturer. And there are in fact, a couple or maybe even more than 2 different infusion pumps that are used in combination with Remodulin. But as Andy pointed out, it's quite a different situation with Tyvaso being approved as a drug device combination. We ourselves tried more than once to reproduce the dispersal pattern within the bronchi that is associated with our device. It was in fact, not possible. Oftentimes other insulation devices will provide something that was deeper than the Optineb, perhaps some people could argue "better" than the Optineb, in terms of it's dispersal pattern within bronchi. But what was incontestable is that all of the any other device, it was always very, very different from the Optineb. And therefore, it would not in any way, shape or form come within the approval that was granted for Tyvaso and the Optineb device, as the drug device combination. So it would be -- it's going to be a hoarse of another color for there to be an introduction of a substitute for Tyvaso because of this unique drug device combination approval. And of course, as many of you are aware, this is a device that we own all rights to, the manufacture, so on and so forth. Thanks for the question from Mark's Group. And operator, if you can please take the next question.

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