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Post by sayhey24 on Feb 18, 2023 13:00:43 GMT -5
Who the partner is and what they are partnering for should be interesting. Nova Nordisk makes both Tresiba and icodec. Mike has mentioned a lot in the past that he is excited about the once weekly basal. Novo Nordisk would probably like to replace the pumps with Tresiba/icodec. On the other hand they also make Ozempic. Afrezza could replace that or be added to it. Mike mentioned they did proper dosing in India so results should be even better than Affinity 2. I am not sure Novo Nordisk wants Ozempic replaced unless they think Mounjaro will significantly eat into the GLP1 market. Maybe they show Ozempic plus afrezza beat Mounjaro. I heartily agree with this. There is no way I can see Novo Nordisk is the partner since in addition to the Ozempic (the largest selling GLP-1 and 6th largest prescription drug by Rx dollars last I looked), but they also make Novolog and Fiasp which which pretty much split the RAA market with Lilly. I cannot see them encouraging the use of Afrezza. Maybe its time to load Novolog on Technosphere and NVO starts pitching Inhaled Novolog. |
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Post by peppy on Feb 18, 2023 13:06:28 GMT -5
I heartily agree with this. There is no way I can see Novo Nordisk is the partner since in addition to the Ozempic (the largest selling GLP-1 and 6th largest prescription drug by Rx dollars last I looked), but they also make Novolog and Fiasp which which pretty much split the RAA market with Lilly. I cannot see them encouraging the use of Afrezza. Maybe its time to load Novolog on Technosphere and NVO starts pitching Inhaled Novolog. Novolog would need to be tested and go through approval. That was an awaking when Heard, Afrezza is approved to be made with the 1 regular insulin that was used upon approval. amphastar.com/facilities.htmlYou knew that. |
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Post by sayhey24 on Feb 18, 2023 13:50:28 GMT -5
OK - Aged wants more trials. I want more sales. Let them run the trials with insulin aspart and get it approved. NVO can then sell it with icodec and as an add on to Ozempic and as a better subq Novolog. Plus they can get patent protection.
Its going to work about the same as afrezza and the inhaler does not need the scrutiny it did in the days of Martin Shreli. I bet NVO could even get it approved with no black box nor FEV testing.
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Post by cjm18 on Feb 18, 2023 14:52:18 GMT -5
High level summary of the best points mc made.
1. Clofazimine is “derisked” due to orals being safe but with side effects. Inhaled will be safe. Also less side effects due to lower dose.
2. Trial in India will show higher dosing improves a1c as much as GLP
3. Pump switch trial results will be at June ADA. Larger trial in works. Goal is get ppl off pumps.
4. Tyvaso dpi has very low drop out rate. Medicare is half the patients and the copays are heading down and will be low in 2025. No new trial needed for IPF.
5. Vgo max quarterly sales was 10m with 70 reps in 19q4. We are at 5m and will have 80 reps. Goal is 2.5% of raa market. OmniPod is at 1 billion in sales. ( Is raa market 7b worldwide? )
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Post by prcgorman2 on Feb 18, 2023 15:28:24 GMT -5
Novolog on TechnoSphere would be very similar to Pfizer’s failed Exubera, but with a whistle instead of a bong. The whistle would be more convenient, and a small dose of RAA combined with Afrezza might actually work well. i.e., a hybrid of Afrezza + Fiasp for instance with like a 60%/40% mix (or whatever made sense). Let fast-in/fast-out take are of initial blood glucose spike and then let the RAA with the long tail do the work to avoid stacking with Afrezza.
I’ve been reading a book recently which pointed out that Humulin launch failed at first and it was because the improvement in the “purity” of the insulin over the older pig/cow insulins was no longer much of a concern, and the convenience of the RAA pens that came out about the same time (from Novo Nordisk I believe) ate Humulin’s lunch (after a $1B investment).
This reminded me greatly of the failure of Afrezza to gain traction. Inhalable human insulin instantly available was not as important as “convenience” of using what you already know. The fact that V-Go is selling is another example of convenience, and it needs to be acknowledged that the pens were the exact same thing - a device which provided convenience. agedhippie’s observation that taking multiple doses of Afrezza to manage the spike and subsequent rise that sometimes occurs when fast-in/fast-out Afrezza was out too fast. The pumps and loop systems are additional examples of convenience. This makes me believe that smaller longer-lived “grain of rice” Eversense CGMs may eventually be successful over the products which “fall out” (which I’ve now read and heard multiple times enough to know it’s a real issue).
If//when MannKind uses DTC advertising of Afrezza again, they have to make an issue of watching PWDs taking their insulin in public at a table (or hell, a flying hamburger picnic), or even better, a sporting event, or on the beach. Anyplace where diabetics don’t feel good about putting a pen in their stomach (or wherever) in public. To this day, I’ve never seen one of my relatives or friends ever take insulin in front of others.
Studies, partners, more molecules, and convenience. People definitely are willing to pay for convenience.
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Post by sayhey24 on Feb 18, 2023 15:53:48 GMT -5
Novolog on TechnoSphere would be very similar to Pfizer’s failed Exubera, but with a whistle instead of a bong. The whistle would be more convenient, and a small dose of RAA combined with Afrezza might actually work well. i.e., a hybrid of Afrezza + Fiasp for instance with like a 60%/40% mix (or whatever made sense). Let fast-in/fast-out take are of initial blood glucose spike and then let the RAA with the long tail do the work to avoid stacking with Afrezza. I’ve been reading a book recently which pointed out that Humulin launch failed at first and it was because the improvement in the “purity” of the insulin over the older pig/cow insulins was no longer much of a concern, and the convenience of the RAA pens that came out about the same time (from Novo Nordisk I believe) ate Humulin’s lunch (after a $1B investment). This reminded me greatly of the failure of Afrezza to gain traction. Inhalable human insulin instantly available was not as important as “convenience” of using what you already know. The fact that V-Go is selling is another example of convenience, and it needs to be acknowledged that the pens were the exact same thing - a device which provided convenience. agedhippie’s observation that taking multiple doses of Afrezza to manage the spike and subsequent rise that sometimes occurs when fast-in/fast-out Afrezza was out too fast. The pumps and loop systems are additional examples of convenience. This makes me believe that smaller longer-lived “grain of rice” Eversense CGMs may eventually be successful over the products which “fall out” (which I’ve now read and heard multiple times enough to know it’s a real issue). If//when MannKind uses DTC advertising of Afrezza again, they have to make an issue of watching PWDs taking their insulin in public at a table (or hell, a flying hamburger picnic), or even better, a sporting event, or on the beach. Anyplace where diabetics don’t feel good about putting a pen in their stomach (or wherever) in public. To this day, I’ve never seen one of my relatives or friends ever take insulin in front of others. Studies, partners, more molecules, and convenience. People definitely are willing to pay for convenience. I don't think insulin aspart on TechnoSphere would be very similar to Pfizer’s failed Exubera. Exubera was a hexamer. What I am suggesting is loading insulin aspart as a monomer on technosphere. It should have about the same PK profile as afrezza. In fact, it may solve one of the issues afrezza has with some people who report afrezza stops working or they need more and more. These people are building up antibodies to human insulin. Some add some subq RAA others stop using afrezza all together. For some reason the immune system is not attacking the analog. Now when it comes to convenience nothing beats afrezza. I doubt you will find many pump users who say their pumps are convenient. What's convenient having to load a new V-Go daily with insulin and then pasting it on and wearing that buldge all day and then guess how many times to push the button when eating? Lets not forget what Mike said about V-Go. When they had 80 sales reps they had an ceiling of $10M in sales. The advantage of V-Go was it was a way to get Medicare Part B to pay for the RAA. As Mike said the passage of the Inflation Reduction Act caught them by surprise and now they have $35 Part D afrezza and Mike has a board mandate to make afrezza and V-Go breakeven by year end and he already said afrezza was. |
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Post by agedhippie on Feb 18, 2023 18:57:17 GMT -5
... In fact, it may solve one of the issues afrezza has with some people who report afrezza stops working or they need more and more. These people are building up antibodies to human insulin. Some add some subq RAA others stop using afrezza all together. For some reason the immune system is not attacking the analog. Now when it comes to convenience nothing beats afrezza. I doubt you will find many pump users who say their pumps are convenient. What's convenient having to load a new V-Go daily with insulin and then pasting it on and wearing that buldge all day and then guess how many times to push the button when eating? Lets not forget what Mike said about V-Go. When they had 80 sales reps they had an ceiling of $10M in sales. The advantage of V-Go was it was a way to get Medicare Part B to pay for the RAA. As Mike said the passage of the Inflation Reduction Act caught them by surprise and now they have $35 Part D afrezza and Mike has a board mandate to make afrezza and V-Go breakeven by year end and he already said afrezza was. I don't know why Afrezza would stop working for people, but if it was due to antibodies adding RAA wouldn't fix the problem. Sometime you just go through phases of needing more insulin for no good reason, and sometimes insulins just tail off. I have seen this happen when RAA arrived and some people had to stay on animal insulin, the same happened with Fiasp. Nobody really knows why. The new pumps are incredibly convenient, you don't have to touch them between meals, you don't have to watch you CGM to see if you need more insulin you can just let the system look after everything without bothering you. That aspect is unbeatable. I have absolutely no idea why anyone would use the V-Go - for me it's the worst of all worlds as I have something glued to me while still having to to all the work (and the work had better come in even numbers of units!) I don't think the V-Go was ever Part B since it's not DME as it's disposable. All the references I can find say V-Go is covered under Part D. I could be wrong, but I though a device had to be covered by Part B for free insulin. Has it ever been stated that insulin was free with the V-Go? |
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Post by nylefty on Feb 18, 2023 20:07:35 GMT -5
I don't think that anything is "free" under Part B. Medicare pays 80 percent, but the patient pays 20 percent.
In any case, Part B does not cover V-Go.
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Post by JEvans on Feb 18, 2023 20:43:46 GMT -5
Re: "The new pumps are incredibly convenient, you don't have to touch them between meals".....So is McDonalds and fast food, but I'd still rather take the time out of my life to be healthy and make my own meals.
10 seconds is pretty convenient to breath in a healthy dose of insulin in my opinion and you still have the advantage of taking off your shirt and enjoying shirtlessness and water sports or a shower without the inconveients of that apect of a machine hooked to your body that you have to remove. Sleeping is uncomfortable too....
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Post by sayhey24 on Feb 20, 2023 10:00:10 GMT -5
... In fact, it may solve one of the issues afrezza has with some people who report afrezza stops working or they need more and more. These people are building up antibodies to human insulin. Some add some subq RAA others stop using afrezza all together. For some reason the immune system is not attacking the analog. Now when it comes to convenience nothing beats afrezza. I doubt you will find many pump users who say their pumps are convenient. What's convenient having to load a new V-Go daily with insulin and then pasting it on and wearing that buldge all day and then guess how many times to push the button when eating? Lets not forget what Mike said about V-Go. When they had 80 sales reps they had an ceiling of $10M in sales. The advantage of V-Go was it was a way to get Medicare Part B to pay for the RAA. As Mike said the passage of the Inflation Reduction Act caught them by surprise and now they have $35 Part D afrezza and Mike has a board mandate to make afrezza and V-Go breakeven by year end and he already said afrezza was. I don't know why Afrezza would stop working for people, but if it was due to antibodies adding RAA wouldn't fix the problem. Sometime you just go through phases of needing more insulin for no good reason, and sometimes insulins just tail off. I have seen this happen when RAA arrived and some people had to stay on animal insulin, the same happened with Fiasp. Nobody really knows why. The new pumps are incredibly convenient, you don't have to touch them between meals, you don't have to watch you CGM to see if you need more insulin you can just let the system look after everything without bothering you. That aspect is unbeatable. I have absolutely no idea why anyone would use the V-Go - for me it's the worst of all worlds as I have something glued to me while still having to to all the work (and the work had better come in even numbers of units!) I don't think the V-Go was ever Part B since it's not DME as it's disposable. All the references I can find say V-Go is covered under Part D. I could be wrong, but I though a device had to be covered by Part B for free insulin. Has it ever been stated that insulin was free with the V-Go? Aged - again you are right - almost. V-Go is suppose to get coded as HCPCS code A9274 for External ambulatory insulin delivery system. This falls under Plan D. The thing is I am not sure it always is and it seems sometimes they are coding it as an insulin pump, IDK. To be honest I don't really care much about V-Go especially since Mike just admitted it will never be a big seller. No one seems to have a good reason why in a few cases afrezza starts not working as well as it did and the PWDs start requiring a lot more. It does not seem too common but it has been reported. At that point the analogs still work fine. Maybe just that little difference in the molecule makes a big difference. Maybe TS Novolog would work in these cases. I think it would be worth a try especially since Mike likes icodec so much and if NVO would rather sell TS Novolog than afrezza, I would be OK with that. Taking the UTHR model of Tyvaso to NVO and Novolog might be another big money maker for MNKD. I would be OK seeing NVO running some trials with Ozempic too for TS Novolog. The funny thing about afrezza on the social media is I never see anyone saying they hate afrezza. The biggest issue is still the cough some get. I do see complaints from pump users about their pumps and I see many afrezza users who were pump users saying they would never go back. Clearly we are not going to agree on "how great" pumps are. |
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Post by agedhippie on Feb 20, 2023 10:28:56 GMT -5
Aged - again you are right - almost. V-Go is suppose to get coded as HCPCS code A9274 for External ambulatory insulin delivery system. This falls under Plan D. The thing is I am not sure it always is and it seems sometimes they are coding it as an insulin pump, IDK. To be honest I don't really care much about V-Go especially since Mike just admitted it will never be a big seller. ... The funny thing about afrezza on the social media is I never see anyone saying they hate afrezza. The biggest issue is still the cough some get. I do see complaints from pump users about their pumps and I see many afrezza users who were pump users saying they would never go back. Clearly we are not going to agree on "how great" pumps are. So I am right except where they get the coding wrong? That mistake will be corrected pretty fast when the claim is bounced as incorrectly coded. Give Afrezza a chance, there are a few orders of magnitude more pump users than there are Afrezza users so it's unsurprising there are more pump complaints.  |
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Post by sportsrancho on Feb 20, 2023 10:34:49 GMT -5
Nobody hates Afrezza. It’s more convenient, it’s faster, what I see are people saying it isn’t working, that’s because they’re not dosing it properly. I look at everything, I take snapshots of all the complaints. It’s part of my job.
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Post by akemp3000 on Feb 20, 2023 10:37:18 GMT -5
Interesting that some have said the cough is an issue with Afrezza while some say it's no big deal at all, just drink a sip of water first and learn the proper technique. That said, coughing has not been brought up as an issue of concern at all with Tyvaso DPI. Maybe it has to do with inferior marketing and training with Afrezza. Maybe it's just the final issue those against Afrezza can hang their hat on. Maybe there's a difference in the drugs. Regardless, there seems to be a disconnect with the two.
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Post by sayhey24 on Feb 20, 2023 12:32:22 GMT -5
Nobody hates Afrezza. It’s more convenient, it’s faster, what I see are people saying it isn’t working, that’s because they’re not dosing it properly. I look at everything, I take snapshots of all the complaints. It’s part of my job. Sports - come on - Ha! For years Aged has told us so many bad things about afrezza. In the beginning he/she would tell us about how its going to damage his/her lungs and the endo would never prescribe. I came to call this the "Exploding Lung" theory. Then it goes on and on. What I hate about afrezza is that it is still seen by industry leaders as a "niche" drug. If afrezza 2.0 is using insulin aspart instead of insulin human to land a deal with NVO I would all for that. We can call it Novolog DPI. Of course I am probably dreaming again and if I were to contact Lars Jorgensen he would probably tell me he has never talked with Mike. I sure hope I am wrong about that but based on recent experience I doubt it. When Mike starts talking icodec and using afrezza with it, that seems pretty exciting, atleast to me. Adding afrezza to Ozempic would seem to be a no brainer. IDK, hope springs external and one day, maybe. |
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Post by mango on Feb 20, 2023 12:58:01 GMT -5
We don’t need a Aspart Technosphere. What makes it Aspart, or now Fiasp rather, is the fact it’s not even insulin. It’s an altered foreign protein.
Fiasp is a hexameric insulin analog with an altered amino acid sequence, proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae (baker's yeast). Right away we know we aren’t dealing with real human insulin anymore. But wait, it get worse…
Fiasp also contains: niacinamide, arginine, USP, glycerin, phenol, metacresol, zinc, disodium hydrogen phosphate dihydrate, sodium chloride, water, hydrochloric acid and/or sodium hydroxide.
Insulin aspart has the empirical formula C256H381N65079S6 and a molecular weight of 5825.8 daltons.
Afrezza consists of human insulin (produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli), FDKP and polysorbate 80.
Chemically, human insulin has the empirical formula C257H383N65O77S6 and a molecular weight of 5808.
As you can see, only one of the above is real, human insulin while the other is “something else” that attempts (rather poorly) to mimic the real thing.
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