United Therapeutics and MannKind Announce Closing of License
Nov 17, 2018 13:16:01 GMT -5
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Post by mango on Nov 17, 2018 13:16:01 GMT -5
Comparing the Arena and MannKind deals is really like comparing apples to mangos.
TreT and the Phase 1 study cost MannKind very little. Arena discovered and developed Ralinepag themselves so they are really two entirely different scenarios.
However, Rothblatt stated that it is an honor to be working with MannKind, and that they are fully integrated with an UT R&D team at their Research Triangle Park location in North Carolina.
MannKind has a long-term future with United, and this is merely the beginning.
From Rothblatt:
"And the team at MannKind is one of the absolute best groups of people that we've ever had the honor to work with. They are now fully integrated into our Clinical Drug Development Group over in Research Triangle Park. And I'm confident that once the MannKind device is approved that that will augur yet additional thousands of patients..."
I put this together from the UT call, and to me it looks like there's nothing to worry about. Plus, you have to figure in the time it will take to transition a patient from inhaled treprostinil to Ralinepag, and we have no data available showing short and long-term success with transitioning people off Tyvaso and onto Ralinepag.
—And the team at MannKind is one of the absolute best groups of people that we've ever had the honor to work with. They are now fully integrated into our Clinical Drug Development Group over in Research Triangle Park. And I'm confident that once the MannKind device is approved that that will augur yet additional thousands of patients on Tyvaso
—So very rapid advance in simultaneous dry powder with MannKind, liquid with MedSpray and the PRN showing that you throw esuberaprost on top of that, it all works longer and better. And anyway you add up one, two, and three, to me it's like 6,000 more patients. I don't know. Don't get hung up on the number 6,000, it could be much larger. So I think Tyvaso is another huge grower of United Therapeutics' patients on treprostinil.
—I hope I've given you a sense of confidence, the data behind the confidence, the substance behind the confidence that we have, the United Therapeutics treprostinil franchise is going to continue to grow many thousands of patients more, year-after-year, after this very exciting reach of our second highest level of treprostinil patients ever, which we reached during this past quarter.
—I didn't have time to talk about what we're doing in terms of our Orenitram combo pill and our Orenitram once daily pill, but all that stuff is going forward as well.
—So we're not going to go into the minutia of each particular product and how many thousands of patients are on each particular product. But I do think that I completely agree with you that the total number of United Therapeutics patients on treprostinil is an excellent barometer of how well the company is doing.
—There is another subset of pulmonary fibrosis which is associated with pulmonary hypertension. We have a Phase III trial now enrolling patients called the PERFECT trial, and it's enrolling quite well. That's a growth opportunity for Tyvaso thousands of new patients I mentioned before.
—Second best number of patients on our treprostinil franchise ever, and the forecast is for continued growth in total patients on treprostinil through Remodulin, Tyvaso, Orenitram, and the ever-growing number of new forms of both molecules that will provide advantages to physicians and providing patient care, as well as growth outside of pulmonary hypertension now into pulmonary fibrosis and into small cell lunch cancer.
—Before I go into those differentiable aspects, let me mention the most important thing from a scientific standpoint is that our research has shown that treprostinil uniquely activates the EP2 receptor in the pulmonary vascular bed. And this is something which is not matched by other prostacyclin analogs or prodrugs of prostacyclin and it seems to have a significant pharmacodynamic impacts that are particularly relevant to the progress of pulmonary hypertension and the natural history of the disease. So we feel very fortunate that the treprostinil franchise, our home franchise, is one that uniquely activates this EP2 receptor in the pulmonary vasculature.
—But now let me describe how our productization of that treprostinil franchise gives us some really exciting products and gives us the confidence to say that total patients on United Therapeutics treprostinil products are very, very likely and we are quite confident that they will continue to grow year-after-year for the coming years.
• Something to keep in mind here, and this is absolutely key IMO, is this:
"our research has shown that treprostinil uniquely activates the EP2 receptor in the pulmonary vascular bed. And this is something which is not matched by other prostacyclin analogs or prodrugs of prostacyclin and it seems to have a significant pharmacodynamic impacts that are particularly relevant to the progress of pulmonary hypertension and the natural history of the disease"
As Rothblatt also pointed out, when Tyvaso is used with esuberaprost, inhaled treprostinil delivers a sustained vasodilator effect, lasting much longer and working much better.
—The next area is Tyvaso. I'm pleased to announce that we have completed the necessary number of events that we need for the unblinding of the BEAT trial, which is a combination of Tyvaso, esuberaprost trial meant to show that when Tyvaso is boosted with esuberaprost that there's a reduction in morbidity and mortality, that is great for the patients, those patients can use our drugs for longer period of time. And that unblinding is scheduled to occur at the end of March of 2019. And then we are queuing ourselves up for a filing on esuberaprost in combination with Tyvaso for the end of August 2019. So I do believe that that augurs very positively for Tyvaso.