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Post by centralcoastinvestor on Apr 8, 2019 9:06:23 GMT -5
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Post by #NoMoreNeedles on Apr 8, 2019 9:07:21 GMT -5
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Post by boca1girl on Apr 8, 2019 9:10:15 GMT -5
Does this failure have a direct effect on TreT? I posted this article under Other Biopharmaceuticals because I don’t know if the two drugs are for the same purpose. |
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Post by centralcoastinvestor on Apr 8, 2019 9:12:22 GMT -5
Does this failure have a direct effect on TreT? I posted this article under Other Biopharmaceuticals because I don’t know if the two drugs are for the same purpose. They both treat PAH. There was some discussion awhile back that the tablets would replace the inhaled avenue of treatment which would be a risk to TreT in the long run. It now appears that UTHR is dropping the whole tablet program. And if UTHR isn’t going after tablet treatment of PAH then no one is. I believe this is very positive news for MannKind. Not that I wish any harm to UTHR or better treatments for PAH. TreT is the future for treating PAH in my opinion. (By the way, I did not see that you had already posted this info otherwise I would not have posted it again. Sorry about that.) |
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Post by stevil on Apr 8, 2019 10:20:57 GMT -5
It's my understanding of PAH that there are progressive treatments depending on the severity of the disease. Remember that Viagra was first developed for the indication of PAH, so there are still oral formulations for early stages of the disease (Revatio) with progression to inhaled medications for moderate disease and then IV drugs for severe disease.
All that to say, I'm not in research, so I won't speak to the prospect of TreT being a "one size fits all" therapy, but if it's to be so, it will take extensive trials like we're seeing with Afrezza. It's really hard to put a value on TreT without seeing trial data and the extent of its indication. One would think it would be better than current moderate treatment, but whether it replaces severe therapies remains to be seen. Simply because it acts as an injectable drug by entering the bloodstream through the lungs does not mean it will be as efficacious as other intravenous molecules. Trepostinil is a much older drug and advances have been made since its creation.
As with most things on this board, be wary of the complete naysayers and the cheerleaders. The truth probably lies somewhere in the middle. Right now, we should expect TreT to replace Tyvaso's sales, assuming UTHR pushes hard and educates doctors. Whether it will extend far beyond that is unknown.
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Post by brotherm1 on Apr 8, 2019 10:29:39 GMT -5
It would certainly be interesting if UTHR would drop the oral version of ralinepag and go the inhaled route. From the UTHR February 10k page 16 “...(1) Arena granted to us perpetual, irrevocable and exclusive rights throughout the universe to develop, manufacture and commercialize ralinepag; (2) Arena transferred to us certain other assets related to ralinepag, including, among others, related domain names and trademarks, permits, certain contracts, inventory, regulatory documentation, Investigational New Drug (IND) Application No. 109021 (related to ralinepag) and non-clinical, pre-clinical and clinical trial data; and (3) we assumed certain limited liabilities from Arena, including, among others, all obligations arising after the closing under the assumed contracts and the IND described above; and (4) we paid Arena an upfront payment of $800.0 million. We will also pay Arena (1) a one-time payment of $250.0 million for the first, if any, marketing approval we receive in the United States for an inhaled version of ralinepag to treat PAH...” seekingalpha.com/filing/4374136#/A2237754Z10-K_HTM_DK10401_ITEM_1A__RISK_FACTORS |
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Post by stevil on Apr 8, 2019 10:30:28 GMT -5
AAFP usually has good resources that (I think) is at least understandable by most educated laypeople. Here's an article on the complexity of the disease and different treatment options www.aafp.org/afp/2016/0915/p463.html |
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Post by harryx1 on Apr 8, 2019 11:37:41 GMT -5
It's my understanding of PAH that there are progressive treatments depending on the severity of the disease. Remember that Viagra was first developed for the indication of PAH, so there are still oral formulations for early stages of the disease (Revatio) with progression to inhaled medications for moderate disease and then IV drugs for severe disease. All that to say, I'm not in research, so I won't speak to the prospect of TreT being a "one size fits all" therapy, but if it's to be so, it will take extensive trials like we're seeing with Afrezza. It's really hard to put a value on TreT without seeing trial data and the extent of its indication. One would think it would be better than current moderate treatment, but whether it replaces severe therapies remains to be seen. Simply because it acts as an injectable drug by entering the bloodstream through the lungs does not mean it will be as efficacious as other intravenous molecules. Trepostinil is a much older drug and advances have been made since its creation. As with most things on this board, be wary of the complete naysayers and the cheerleaders. The truth probably lies somewhere in the middle. Right now, we should expect TreT to replace Tyvaso's sales, assuming UTHR pushes hard and educates doctors. Whether it will extend far beyond that is unknown. Here's the truth...  And the CEO of UTHR has stated that if TreT is approved they will move ~100% of patients to that platform. |
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Post by boca1girl on Apr 8, 2019 12:28:50 GMT -5
I don’t know but does TreT do this? Are / were the two drugs intended to have the same end points: ...”delayed time to first clinical worsening event.”
“The BEAT clinical study of esuberaprost tablets in patients suffering from pulmonary arterial hypertension did not meet its primary endpoint of delayed time to first clinical worsening event.”
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Post by figglebird on Apr 8, 2019 12:38:00 GMT -5
the implications of this are potentially uncertain though I believe it likely lies somewhere in the middle as stated above for now- Watson is allowed to come to market with generic tyvasso in 2025 w the caveat that they can enter sooner based on unown events that have not been reported - if that event ended up being the ultimate approval or non-approval of this particular medication which was used in combination with Tyvasso for p3 it begs numerous questions that could have very positive implications for mankind and dryvasso but it could also present limiting ones it's impossible to know without understanding how the FDA will look at dryvasso or without understanding exactly what Martin rosenblatt/jeffries mean about this trial having an extension component to it but I imagine with United's portfolio the way it is - the pship w them renains greatly undervalued
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Post by figglebird on Apr 8, 2019 13:36:27 GMT -5
Upon further research I would say the patents pending are probably more important now than prior... there are other ones besides this that relate to Tyvasso eliminating just one pending...
so basically appears dryvasso trial will be crucial... prob more so now.
per united filing
"Under our license agreement with MannKind, we have an exclusive license to a variety of granted and pending patents and patent applications related to treprostinil inhalation powder and the Dreamboat® and Cricket® devices, including multiple patent families covering the U.S. and other major market countries. These patents cover drug formulation, devices and device components, and manufacturing processes and intermediates. Expiration dates for issued patents range from the mid-2020s to the mid-2030s. Additional patents subject to pending patent applications, if issued, would have expiration dates in the late 2030s. Many of these patents would be eligible for listing in the Orange Book. For a description of the license agreement, please refer to the section above entitled Research and Development—Treprostinil Technosphere."
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Post by stevil on Apr 8, 2019 17:15:25 GMT -5
Here's the truth... And the CEO of UTHR has stated that if TreT is approved they will move ~100% of patients to that platform. I don't know why you say here's the truth as though anything I said was factually incorrect. It may be UTHR's plan to switch 100% of Tyvaso to TreT, but that doesn't always translate over. Expecting TreT to furiously outperform Tyvaso is probably a bad assumption. My exact words were "Right now, we should expect TreT to replace Tyvaso's sales, assuming UTHR pushes hard and educates doctors. Whether it will extend far beyond that is unknown. " I'm not sure how your post made that statement incorrect. Envision a scenario where a doctor prescribes Tyvaso but finds out it's discontinued. If a UTHR rep hasn't made their rounds to that doctor's office, they're not going to switch to TreT, they'll switch it to something else. That was the point of my post. UTHR is going to have to market TreT as a though it is a new drug. I won't comment too far outside of the lines but will posit this one question- if the market size is about the same, is UTHR going to aggressively market TreT to make the same amount of money (actually less since MNKD gets their cut too) they otherwise would have already? For all intents and purposes, TreT is superior to Tyvaso. But will it be indicated for more patients? Will they do another expensive superiority trial where they compare it against other medications or just let ease of use be the main driver for prescriptions? Unless I'm missing something, the studies they're doing are comparing TreT to Tyvaso as well as completing a safety trial, not comparing it to other drugs in its class. UTHR must have seen enough potential to recoup all of these costs and more, otherwise they probably wouldn't have inked the deal. I won't sit here and play armchair quarterback. Certainly UTHR has done their homework and knows how this all plays out. Just color me a little skeptical about this blowing Tyvaso out of the water for the reasons I stated above. A lot of this is riding on how aggressively UTHR markets TreT and how much they're willing to spend to ensure its success. |
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Post by mango on Apr 8, 2019 19:43:33 GMT -5
Here's the truth... And the CEO of UTHR has stated that if TreT is approved they will move ~100% of patients to that platform. I don't know why you say here's the truth as though anything I said was factually incorrect. It may be UTHR's plan to switch 100% of Tyvaso to TreT, but that doesn't always translate over. Expecting TreT to furiously outperform Tyvaso is probably a bad assumption. My exact words were "Right now, we should expect TreT to replace Tyvaso's sales, assuming UTHR pushes hard and educates doctors. Whether it will extend far beyond that is unknown. " I'm not sure how your post made that statement incorrect. Envision a scenario where a doctor prescribes Tyvaso but finds out it's discontinued. If a UTHR rep hasn't made their rounds to that doctor's office, they're not going to switch to TreT, they'll switch it to something else. That was the point of my post. UTHR is going to have to market TreT as a though it is a new drug. I won't comment too far outside of the lines but will posit this one question- if the market size is about the same, is UTHR going to aggressively market TreT to make the same amount of money (actually less since MNKD gets their cut too) they otherwise would have already? For all intents and purposes, TreT is superior to Tyvaso. But will it be indicated for more patients? Will they do another expensive superiority trial where they compare it against other medications or just let ease of use be the main driver for prescriptions? Unless I'm missing something, the studies they're doing are comparing TreT to Tyvaso as well as completing a safety trial, not comparing it to other drugs in its class. UTHR must have seen enough potential to recoup all of these costs and more, otherwise they probably wouldn't have inked the deal. I won't sit here and play armchair quarterback. Certainly UTHR has done their homework and knows how this all plays out. Just color me a little skeptical about this blowing Tyvaso out of the water for the reasons I stated above. A lot of this is riding on how aggressively UTHR markets TreT and how much they're willing to spend to ensure its success. Treprostinil Technosphere is the next generation of inhaled treprostinil therapy, and it will replace Tyvaso 100%. Martine Rothblatt has made it perfectly clear, numerous times—MannKind's inhalation devices are revolutionary, and their TreT drug/device combo will be a life-changer compared to Tyvaso. TreT is 100% superior to Tyvaso and will be 100% replacing it. Currently, that's WHO group 1, but potentially WHO group 3 (PH-COPD & PH-ILD) —and possibly more, will have to wait and see. No approved therapies for WHO group 3 currently. Tyvaso would be the first if the trials succeed. I cannot make sense of your hypothetical scenario. What is the physician gonna prescribe instead of TreT in that picture? Are they just gonna literally discontinue their inhaled treprostinil therapy entirely? That would be ridiculous. What if they use Tyvaso in combo with other med(s)? Just abruptly stop inhaled treprostinil therapy and select something else? Would they even continue using treprostinil at all? Pump? Injection? I can't see that unless it were clinically indicated. I really believe your scenario is FUD. Rothblatt is no flake, and we ain't goin to Hell in a bucket. |
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Post by cretin11 on Apr 8, 2019 23:41:43 GMT -5
If TreT replaces Tyvaso and generates the same revenue, then how much revenue is that - And how much do we (MNKD) see from it? I think we get “low double digit” royalties (sorry going from memory and I’m sure all this info is in other threads) which I’m guessing is 15% give or take a few points?
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Post by mango on Apr 8, 2019 23:46:04 GMT -5
If TreT replaces Tyvaso and generates the same revenue, then how much revenue is that - And how much do we (MNKD) see from it? I think we get “low double digit” royalties (sorry going from memory and I’m sure all this info is in other threads) which I’m guessing is 15% give or take a few points? I think mannmade, maybe it was, did the numbers some time back. I have a headache from reading a paper on how safe SGLT2-inhibitors are so I might be off— ~400M currently ------------ Royalties: 10% = 40M 15% = 60M ------------- Rothblatt has indicated that sales will be much higher in the future. I think ~1B, but may be wrong. |
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