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Post by lennymnkd on Jun 7, 2023 17:39:14 GMT -5
GIP
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Post by sayhey24 on Jun 7, 2023 18:26:44 GMT -5
... stevil , Mounjaro packing a 1,2, punch? Effectively yes. The added benefit is that GIP helps with nausea (they use it with some chemotherapy) as well as it's glucose management properties. Mounjaro will take over from Ozempic, but I suspect Novo Nordisk is already working on their version. I sounds like we all think Mounjaro is going to crush Ozempic and Wegovy sales. It sure seems like Novo Nordisk needs to be doing something. Why not Wegovy DPI? It sure seems UTHR has had great success with Tyvaso DPI. Maybe Doug Langa never considered it. Maybe he should.
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Post by agedhippie on Jun 7, 2023 22:47:51 GMT -5
Effectively yes. The added benefit is that GIP helps with nausea (they use it with some chemotherapy) as well as it's glucose management properties. Mounjaro will take over from Ozempic, but I suspect Novo Nordisk is already working on their version. I sounds like we all think Mounjaro is going to crush Ozempic and Wegovy sales. It sure seems like Novo Nordisk needs to be doing something. Why not Wegovy DPI? It sure seems UTHR has had great success with Tyvaso DPI. Maybe Doug Langa never considered it. Maybe he should. If the problem is Mounjaro then the issue is the GIP (Novo already have a GIP themselves in phase 2) so the answer is to develop that next gen drug and not focus on the last gen drug. Realistically Ozempic will hold market share for some time since currently they are constrained by their manufacturing and are selling everything they can make.
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Post by letitride on Jun 8, 2023 3:00:47 GMT -5
I believe the real answerer here is these drugs sell because they provide real visible results now without taking people out of their comfort zone, long term consequences be dammed. This should be one of the greatest selling points for Afrezza now that it can be seen with the help of a CGM, especially with the lack of long term consequences. Make lack of a comfort zone comfortable.
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Post by prcgorman2 on Jun 8, 2023 6:04:21 GMT -5
This is why the pediatrics strategy is so important. The comfort zone for folks who’ve been stabbing themselves with leetle teeny tiny needles for years is to keep stabbing themselves. Kids who grow up with Afrezza and a CGM (another teensy little needle in most cases - for now) should be most comfortable with the convenience, speed (aka superior effectiveness) and SAFETY of Afrezza.
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Post by sayhey24 on Jun 8, 2023 6:21:52 GMT -5
I sounds like we all think Mounjaro is going to crush Ozempic and Wegovy sales. It sure seems like Novo Nordisk needs to be doing something. Why not Wegovy DPI? It sure seems UTHR has had great success with Tyvaso DPI. Maybe Doug Langa never considered it. Maybe he should. If the problem is Mounjaro then the issue is the GIP (Novo already have a GIP themselves in phase 2) so the answer is to develop that next gen drug and not focus on the last gen drug. Realistically Ozempic will hold market share for some time since currently they are constrained by their manufacturing and are selling everything they can make. Hey - as I have said from the beginning when I say GLP1 I have been lumping Mounjaro in with that. If Doug is already ready to roll on a subq GLP1/GIP maybe putting that on TS provides the market advantage over Mounjaro. Maybe its gen 2.0 for him. It seems to have done wonders for Tyvaso. Who else wants to sell a few $B into the diet space? What is Merck doing? They signed that deal a few years ago with Hanmi for the GLP1. What are they doing with GIP. Maybe all this stuff should be on TS. How about other BPs. How about Martine? Maybe she wants to get into a new market. She is building a TS factory. Maybe she can build a bigger one. Here is what I know, it sure seems like there are a lot of potential partnering opportunities for a multi $B market and if Peter was right TS provides a real advantage. It also seems like right now MNKD is doing nothing. I sure hope that changes. Maybe I will be shocked at ADA2023. At the same time we are putting V-Go in the sales reps bag and it seems like there is a hole in their bag as no one wants it while there are millions on TikToc watching weight lose videos and then paying cash out of pocket.
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Post by agedhippie on Jun 8, 2023 8:17:09 GMT -5
Hey - as I have said from the beginning when I say GLP1 I have been lumping Mounjaro in with that. If Doug is already ready to roll on a subq GLP1/GIP maybe putting that on TS provides the market advantage over Mounjaro. Maybe its gen 2.0 for him. It seems to have done wonders for Tyvaso. ... if Peter was right TS provides a real advantage. It also seems like right now MNKD is doing nothing. I sure hope that changes... Tyvaso was already an inhaled drug, Martine simply moved the inhaler from one inhaler to another. With GLP-1 Novo Nordisk would be moving from injected to inhaled which is a hard sell, not least because the only example of that is Afrezza which has not exactly been a resounding commercial success. From a marketing standpoint Novo Nordisk doesn't need an inhaler, they just need a competitive version and they can do the rest leveraging their relationships. The key word on TS-GLP1 is IF. Nobody knows how well it works beyond the fact that it doesn't kill you which is all a Phase 1 trial proves (also why Phase 1 trials are cheap and easy to do). There are a pile of unanswered questions; does it have side effects if you take it more than one, does it have side effects is you prolong the action (when the original work was done GLP-1 was a twice daily shot, now it's weekly so there is an expectation), how effective is it (more/less/same, as Mounjaro), will GLP-1 alone be sufficient or is GIP also needed as it seems that is more effective both for diabetes and weight loss? And the key question; how much money does Mike want to spend to roll the dice on those questions. I can see an announcement to help the share price, I don't see it ever coming to market because of the upfront costs.
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Post by prcgorman2 on Jun 8, 2023 8:44:03 GMT -5
The administration route of subcutaneous versus inhaled does make a difference, obviously, or TS and Afrezza would never have been developed. The question is whether the administration route for TS GLP-1 is better, not non-inferior, and certainly not inferior. The quick access to the bloodstream does not seem to be an advantage if the drug is supposed to last a week.
So then the question is whether quick and easy access to the bloodstream provides some advantage in terms of less drug used (cheaper to manufacture?) and reduced toxicity and side-effects. These (less cost and less toxicity and side effects) would be material advantages.
I've no idea whether those advantages are likely (not saying they aren't likely, just that I'm not qualified to say) or how much it would cost to develop, test, get approved, and market.
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Post by sayhey24 on Jun 8, 2023 14:35:03 GMT -5
Hey - as I have said from the beginning when I say GLP1 I have been lumping Mounjaro in with that. If Doug is already ready to roll on a subq GLP1/GIP maybe putting that on TS provides the market advantage over Mounjaro. Maybe its gen 2.0 for him. It seems to have done wonders for Tyvaso. ... if Peter was right TS provides a real advantage. It also seems like right now MNKD is doing nothing. I sure hope that changes... Tyvaso was already an inhaled drug, Martine simply moved the inhaler from one inhaler to another. With GLP-1 Novo Nordisk would be moving from injected to inhaled which is a hard sell, not least because the only example of that is Afrezza which has not exactly been a resounding commercial success. From a marketing standpoint Novo Nordisk doesn't need an inhaler, they just need a competitive version and they can do the rest leveraging their relationships. The key word on TS-GLP1 is IF. Nobody knows how well it works beyond the fact that it doesn't kill you which is all a Phase 1 trial proves (also why Phase 1 trials are cheap and easy to do). There are a pile of unanswered questions; does it have side effects if you take it more than one, does it have side effects is you prolong the action (when the original work was done GLP-1 was a twice daily shot, now it's weekly so there is an expectation), how effective is it (more/less/same, as Mounjaro), will GLP-1 alone be sufficient or is GIP also needed as it seems that is more effective both for diabetes and weight loss? And the key question; how much money does Mike want to spend to roll the dice on those questions. I can see an announcement to help the share price, I don't see it ever coming to market because of the upfront costs. For upfront costs lets assume $1B. Afrezza cost us $3B+. Earlier in this thread Lenny said - "Pfizer would be an interesting candidate for some sort of partnership. They seem quite interested in this space . Would that be to good to be true" The interesting thing as I started looking at this a bit closer is the desire by other BPs to get rid of the shot. Also interesting is Albert Bourla thinks this is a $90B market - “this is a market that will grow to $90 billion altogether. And we are very confident on that given the current size of the market and the current growth rates.” IDK, thats bigger than I was thinking but even if its $50B, is that big enough to spend $1B? I say yes. We already know TS is great. We know it provides the drug right into the blood stream near as well as intravenous. It has none of the oral GI issues. Its also FDA approved which is a big f-ing deal. The question then is which "GLP1" do you load on it. Maybe Lenny has the answer- danuglipron. Danuglipron is seeing great weight loss results maybe better than Mounjaro but its showing troubling drop-out rates because of nausea. In their latest study results there was a discontinuation rate of the medication of up to 34% at the higher doses. Thats not good for Pfizer but sure seems like a great opportunity for Technosphere. Can TS reduce the nausea, IDK but if Peter was right I think there is a pretty great chance and worth spending the money. The big question is would Pfizer be interested? TS is not a pill but maybe its sexier and it is an oral. I guess we need to ask them. In the second article it also mentions Novo is also interested in oral solutions. Bourla said “In all the market research that we are doing, we see that there is a preference in the diabetic population for an oral compared to injectable,” he explained, but said this is particularly true for patients with obesity. An oral drug here “unlocks the market,” www.today.com/health/news/weight-loss-pill-pfizer-rcna87714www.fiercepharma.com/marketing/pfizer-ceo-talks-experimental-oral-glp-1-diabetesobesity-hopeful-90b-lilly-novo-battle
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Post by JEvans on Jun 8, 2023 16:36:28 GMT -5
Is Mike Castenega in this conversation with you guys ? or are you monday-night quarterbacking CEO's for future development because the revenue possibilities sound really good.....
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Post by lennymnkd on Jun 8, 2023 16:46:04 GMT -5
I’ll go first 😀 I’m a Monday morning quarterback .. trying to help the cause .
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Post by sayhey24 on Jun 8, 2023 17:20:51 GMT -5
Is Mike Castenega in this conversation with you guys ? or are you monday-night quarterbacking CEO's for future development because the revenue possibilities sound really good..... I am Thursday-night quarterbacking but I have a field pass. Here is the history - Aged pointed out over a year ago the weight loss Mounjaro was seeing which got my interest for GLP1s in the diet space. I have never been a GLP1 fan for prandial glucose control. Soon after the TikToc videos popped and so did their sales. Over a year ago I asked about the work Peter did in 2007 and got crickets. I think it was stored away with Dave Kendall's lost "veins of gold". Then Mango saw the patent filing in December so they must have found it. I don't think Mike sees the market the same way Albert does. Then again Albert has an entire market research division. Mike doesn't but neither do I. Who knows maybe Mike will change his mind. Mike also doesn't have $1B. He just bought V-Go. Then again, he also bought a new phone and it worked great on the last call. I say- hey, $90B sounds even too big for me to believe. What I found interesting was Albert saying it had to be oral and not a shot to make this market. I agree. Thats what my market research division would have said if I had one. The issue is the same with insulin the GI tract gets in the way and to get the weight reduction they need a lot of their GLP-1R. They said - 120 milligrams, twice daily — lost about 10 pounds in 16 weeks. TS should be able to significantly reduce the amount needed and significantly reduce the 34% drop out rate. 30lbs in 48 weeks sounds as good a Mounjaro which was 25lbs in 40 weeks.
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Post by agedhippie on Jun 8, 2023 17:49:16 GMT -5
Drugs like Danuglipron and Rybelsus are oral meds, they are pills. A TS GLP-1 would be an inhaled drug which is completely different class. No pharma is going to show interest this side of a Phase 2 trial because they want to be sure the side effects are really gone.
Pfizer would be a nice partner, but the question is if they have got over their last attempt to convert an injectable to inhaled (Exubera)
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Post by lennymnkd on Jun 8, 2023 19:40:56 GMT -5
Imagine we’re we would both be Pfizer/ mannkind … if they went with Afrezza/ technosphere… Never too late . A company the size and history of pfizer didn’t get were they are dwelling on past Failures .. i am sure mikes hard work is making the picture clearer for them to evaluate.. not to mention They are right down the street from Danbury.. never know 🤞
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Post by peppy on Jun 8, 2023 20:08:30 GMT -5
OZEMPIC® (semaglutide) injection, for subcutaneous use
——— DOSAGE AND ADMINISTRATION ——— • Start at 0.25 mg once weekly. After 4 weeks, increase the dose to 0.5 mg once weekly.
the long half-life of OZEMPIC® of approximately 1 week.
Injection: 2 mg/3 mL (0.68 mg/mL) available in: • Single-patient-use pen that delivers 0.25 mg or 0.5 mg per injection (3) Injection: 2 mg/1.5 mL (1.34 mg/mL) available in: • Single-patient-use pen that delivers 0.25 mg or 0.5 mg per injection (3).
===============================================================================
"The GLP-1 drugs on the market today are GLP-1 analogs engineered for an extended half life rather than actual GLP-1." aged.
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How does TS GLP-1 make sense?
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