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Post by matt on Aug 18, 2020 14:32:25 GMT -5
Can anyone shed some light on whether the UT press release implies royalties to MNKD would begin prior to 2022? The press release did not suggest royalties earlier than 2022. The relevant language is this: ". . . New Drug Application (sNDA) for Tyvaso® (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD)." Note that it explicitly calls out the solution form of Tyvaso and not the powered form. This is not surprising since UTHR has been marketing Tyvaso in solution for a long time and it is the form of delivery with which UTHR and its clinical centers have the most experience. That translates directly into a faster path through FDA. This is a supplemental application to add ILD as a treatment to the exist label for Tyvaso which is a far simpler process to manage that to try and license a drug for a new disease at the same time as a new formulation. The winning strategy for any drug manufacturer is to get the indications expanded first, then to add different delivery mechanisms. This also implies that there will be more than one formulation available and that the market price of a powered inhaler will matter to the uptake with managed care companies. It is unrealistic to assume that all Tyvaso patients will immediately be switched to TreT because many physicians are unwilling to alter a therapy choice that has been working and Tret may not provide equivalent results for all patients. Similarly, while there are a lot of patients that could potentially benefit from a powered version for treating PAH, there needs to be clinical evidence that the powdered form is equivalent in efficacy to the solution form. Assuming this is the case (it is always dangerous to assume that a trial will turn out as hoped) some patients will get switched to the powered version and some will not. A lot will depend on the clinical data and that will not be available for some time. Likewise, do not forget that Liquida is moving ahead with its dry powdered formulation so by the time TreT hits the market it will likely have a direct competitor along with the liquid versions of treprostinil. Because Liquida is applying for approval under the 505(b)(2) pathway, whatever indications UTHR has approval for will also extended to the Liquida product. That makes the tea leaves difficult to read regarding timing and amount of future royalties, but material royalties are not likely in 2021. |
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Post by bones1026 on Aug 18, 2020 21:55:19 GMT -5
Can anyone shed some light on whether the UT press release implies royalties to MNKD would begin prior to 2022? The press release did not suggest royalties earlier than 2022. The relevant language is this: ". . . New Drug Application (sNDA) for Tyvaso® (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD)." Note that it explicitly calls out the solution form of Tyvaso and not the powered form. This is not surprising since UTHR has been marketing Tyvaso in solution for a long time and it is the form of delivery with which UTHR and its clinical centers have the most experience. That translates directly into a faster path through FDA. This is a supplemental application to add ILD as a treatment to the exist label for Tyvaso which is a far simpler process to manage that to try and license a drug for a new disease at the same time as a new formulation. The winning strategy for any drug manufacturer is to get the indications expanded first, then to add different delivery mechanisms. This also implies that there will be more than one formulation available and that the market price of a powered inhaler will matter to the uptake with managed care companies. It is unrealistic to assume that all Tyvaso patients will immediately be switched to TreT because many physicians are unwilling to alter a therapy choice that has been working and Tret may not provide equivalent results for all patients. Similarly, while there are a lot of patients that could potentially benefit from a powered version for treating PAH, there needs to be clinical evidence that the powdered form is equivalent in efficacy to the solution form. Assuming this is the case (it is always dangerous to assume that a trial will turn out as hoped) some patients will get switched to the powered version and some will not. A lot will depend on the clinical data and that will not be available for some time. Likewise, do not forget that Liquida is moving ahead with its dry powdered formulation so by the time TreT hits the market it will likely have a direct competitor along with the liquid versions of treprostinil. Because Liquida is applying for approval under the 505(b)(2) pathway, whatever indications UTHR has approval for will also extended to the Liquida product. That makes the tea leaves difficult to read regarding timing and amount of future royalties, but material royalties are not likely in 2021. Are you Matthew Pfeffer? Serious question. Just can’t figure out why you choose to share this knowledge with us. You’re a smart guy, nobody can deny that. |
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Post by Clement on Aug 18, 2020 22:06:40 GMT -5
Can anyone shed some light on whether the UT press release implies royalties to MNKD would begin prior to 2022? The press release did not suggest royalties earlier than 2022. The relevant language is this: ". . . New Drug Application (sNDA) for Tyvaso® (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD)." Note that it explicitly calls out the solution form of Tyvaso and not the powered form. This is not surprising since UTHR has been marketing Tyvaso in solution for a long time and it is the form of delivery with which UTHR and its clinical centers have the most experience. That translates directly into a faster path through FDA. This is a supplemental application to add ILD as a treatment to the exist label for Tyvaso which is a far simpler process to manage that to try and license a drug for a new disease at the same time as a new formulation. The winning strategy for any drug manufacturer is to get the indications expanded first, then to add different delivery mechanisms. This also implies that there will be more than one formulation available and that the market price of a powered inhaler will matter to the uptake with managed care companies. It is unrealistic to assume that all Tyvaso patients will immediately be switched to TreT because many physicians are unwilling to alter a therapy choice that has been working and Tret may not provide equivalent results for all patients. Similarly, while there are a lot of patients that could potentially benefit from a powered version for treating PAH, there needs to be clinical evidence that the powdered form is equivalent in efficacy to the solution form. Assuming this is the case (it is always dangerous to assume that a trial will turn out as hoped) some patients will get switched to the powered version and some will not. A lot will depend on the clinical data and that will not be available for some time. Likewise, do not forget that Liquida is moving ahead with its dry powdered formulation so by the time TreT hits the market it will likely have a direct competitor along with the liquid versions of treprostinil. Because Liquida is applying for approval under the 505(b)(2) pathway, whatever indications UTHR has approval for will also extended to the Liquida product. That makes the tea leaves difficult to read regarding timing and amount of future royalties, but material royalties are not likely in 2021. But contract manufacturing revenue is likely in 2021. |
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Post by agedhippie on Aug 19, 2020 8:27:49 GMT -5
Are you Matthew Pfeffer? Serious question. Just can’t figure out why you choose to share this knowledge with us. You’re a smart guy, nobody can deny that. He is not, that is well established going back years. I am grateful that he shares his knowledge. I think he shares because he can and people want the information. You don't have to always be motivated by profit, being helpful is rewarding as well. |
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Post by uvula on Aug 19, 2020 9:13:43 GMT -5
Are you Matthew Pfeffer? Serious question. Just can’t figure out why you choose to share this knowledge with us. You’re a smart guy, nobody can deny that. He is not, that is well established going back years. I am grateful that he shares his knowledge. I think he shares because he can and people want the information. You don't have to always be motivated by profit, being helpful is rewarding as well. It has always puzzled many of us why he spends so much time posting here. I'm a fan of Pfeffer so I don't mean this as an insult, but matt seems to have more CEO level experience than Pfeffer. Also, I'm guessing that if Matt P. Wanted to post here incognito he probably would have picked something other than matt as his screen name. |
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Post by boytroy88 on Aug 19, 2020 9:41:37 GMT -5
He is not, that is well established going back years. I am grateful that he shares his knowledge. I think he shares because he can and people want the information. You don't have to always be motivated by profit, being helpful is rewarding as well. It has always puzzled many of us why he spends so much time posting here. I'm a fan of Pfeffer so I don't mean this as an insult, but matt seems to have more CEO level experience than Pfeffer. Also, I'm guessing that if Matt P. Wanted to post here incognito he probably would have picked something other than matt as his screen name. I believe Matt has mentioned that he was in senior Management either in pharma or bio. I also believe MP had posted here before. |
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Post by LongMNKD on Aug 19, 2020 10:16:48 GMT -5
It's best he remain un-identified. IDC who he is, just keep giving good knowledge.
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Post by harryx1 on Aug 19, 2020 10:21:53 GMT -5
Martine has stated several times that they will move as many patients as they can to TreT once it's approved. I'll go with the CEO of UT as she probably has the most & best insight on what's going to happen. www.genengnews.com/news/united-therapeutics-to-co-develop-mannkinds-dry-powder-treprostinil-for-pah/Moving into Second Generation “On the very same day 21 years ago, we enabled the development of treprostinil into a practical treatment thanks to an invention of the late Al Mann—the discrete, ambulatory, programmable, parenteral infusion pump called the MiniMed 407c. By marrying our molecule and MiniMed's device, Remodulin® was born,” Dr. Rothblatt said in a statement. She referred to Alfred E. Mann, the philanthropist and entrepreneur who founded and funded MannKind among 17 companies in biopharma and other technologies, before his death in 2016 at age 90. “As we now move into the second generation of United Therapeutics products, we are proud to once again team with Al Mann's brilliance, this time with his Dreamboat®, Bluhale®, and Cricket® devices for inhalation,” Dr. Rothblatt added. “ I believe these revolutionary new inhalation devices will accomplish for Tyvaso what our recently-approved Implantable System for Remodulin, pending RemUnity™ system and recently-acquired Trevyent® product represent for Remodulin—a further step toward a next-generation of treprostinil drug-device systems that enhance options for patients, their families, and their prescribers.” |
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Post by mango on Aug 19, 2020 13:10:30 GMT -5
I’m sorry but my understanding of this is that Martine Rothblatt has indicated numerous times that TreT will be replacing Tyvaso entirely. Not some, a little, a select few patients, or even for just those patients whose physicians choose to allow them to transfer over to TreT.
United Therapeutics is phasing out Tyvaso ENTIRELY post-TreT FDA approval and replacing it with TreT. Physicians eventually won’t have a choice between Tyvaso or TreT, it will ONLY be TreT.
😎
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Post by Omega on Aug 21, 2020 11:20:25 GMT -5
The current device used to Inhale Tyvaso (Right Picture) is Barbaric compared to Dreamboat(Pictured Left)... Where have I heard that before? =) But this time we aren't fighting to change the Paradigm since Both are Inhaled, AND we are partnered with the current Big Dog in the field.  |
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Post by sportsrancho on Aug 21, 2020 14:58:37 GMT -5
He is not, that is well established going back years. I am grateful that he shares his knowledge. I think he shares because he can and people want the information. You don't have to always be motivated by profit, being helpful is rewarding as well. It has always puzzled many of us why he spends so much time posting here. I'm a fan of Pfeffer so I don't mean this as an insult, but matt seems to have more CEO level experience than Pfeffer. Also, I'm guessing that if Matt P. Wanted to post here incognito he probably would have picked something other than matt as his screen name. You can’t post incognito, big sister is watching:-)) |
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Post by mango on Aug 21, 2020 20:04:29 GMT -5
The current device used to Inhale Tyvaso (Right Picture) is Barbaric compared to Dreamboat(Pictured Left)... Where have I heard that before? =) But this time we aren't fighting to change the Paradigm since Both are Inhaled, AND we are partnered with the current Big Dog in the field. Nice thing about this go-round is that we are already at the top. No fighting the SoC or trying to convince opinion leaders. United Therapeutics controls this space, they are King of the PAH space. Liquidia is the equivalent of what MannKind is with the diabetes space, but even worse. They don’t have the infrastructure, the pull, the partnership, sales force, and the credibility. United has their name carved in stone with this space. To the moon we go 2021-2022 🚀 |
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