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Post by agedhippie on Oct 31, 2023 10:25:37 GMT -5
But wait, there's more! A new post by Kite today in UTHR thread: " United Therapeutics Announces First Patient Enrolled in Phase 3 TETON PPF Study of Nebulized Tyvaso in Patients with Progressive Pulmonary Fibrosis" mnkd.proboards.com/post/257209/threadThis TETON PPF study is in addition to TETON 1 and TETON 2. (If approved) it will lead to more patients for T-DPI and royalties for MNKD. The trial uses nebulized Tyvaso, not DPI so this doesn't involve MNKD and there are no royalties.
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Post by agedhippie on Oct 31, 2023 8:21:01 GMT -5
Bet the farm? Or is this personal? Based on LQDA advocate claiming they could gobble up fully 10% of the market, I have to wonder if they were way underselling the threat of Yutrepia, or whether Martine had such a falling out with Roger Jeffs that this is less about the money and more about the win. I think the market share is dependent on the pricing. Yutrepia can go to higher doses than Tyvaso-DPI, but UTHR is the incumbent so I think it's a wash there. I am not sure that there is active ill-will between them. I think it's more probable that Martine knows Jeffs has built this business before when he was at UTHR and expects he can do it again and that's the concern.
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Post by agedhippie on Oct 31, 2023 7:37:18 GMT -5
I don't really see anything new in that article. I do see some errors though which make me wonder about the accuracy of the parts I am less familiar with. UTHR absolutely will take over manufacturing for Tyvaso-DPI (I though they had already talked about that), but doing so has zero impact on the royalty stream. I don't see how LFD reaches the conclusion that UTHR can use Technosphere without that royalty.
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Post by agedhippie on Oct 31, 2023 7:11:07 GMT -5
Why do you think LQDA will be much competition for UTHR? Do you think they have a better mouse trap or salesforce? The last I checked it did not seem their solution had the same deep lung penetration as technosphere. If they weren't a threat UTHR would not have spent the amount of time, money, and effort trying to stop them as they have and instead would have just rolled right over them. So are they competition? UTHR appears to think so, but the question is how big. I think that UTHR still gets the majority of the market by virtue of it's salesforce. Deep lung penetration (or not) is irrelevant. What matters is the outcomes and from the trials those are broadly comparable. Don't fixate on the technology at the expense of the outcomes, the outcomes are what doctors care about. There is still UTHR's appeal against the PTAB. If UTHR win that then superiority, sales, and everything else won't matter.
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Post by agedhippie on Oct 30, 2023 16:55:43 GMT -5
Take a look at this patent that UTHR obtained in August: UPSN 11,730,710. Looks like another obstacle for Liquidia. patentimages.storage.googleapis.com/15/e0/cd/76d3b5b9a53d37/US11730710.pdf Btw, that trade secret misappropriation lawsuit (including other claims like unfair trade practices, etc.) is still ongoing against Liquidia and Roscigno. I'm guessing there are other chairs UTHR has thrown in Liquidia's path. Tyvaso DPI is "bet the farm" big for UTHR. I'm sure Martine and her team of lawyers are on it. MC can tend to the manufacturing and otherwise just hold onto Martine's skirt. That patent is irrelevant to LQDA because LQDA had filed for PH-ILD use before the patent was in the Orange Book. Likewise the trade secret case is pretty much irrelevant as well as it's not going to result in a stay which is what UTHR need. Entertainingly Roger Jeffs, the LQDA CEO was the COO and co-CEO at UTHR for 18 years so I dare say he knows where a few bodies are buried. The only thing standing between UTHR and them being forced to compete with LQDA in the open market is the hearing in December.
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Post by agedhippie on Oct 29, 2023 9:13:25 GMT -5
Right, exactly I think we had this whole discussion. Can you explain? I thought and maybe incorrectly that the entire point of the pre auth process was to get approval from an insurance company who does not have afrezza on their formulary. If I go to medicare .gov I see no plans covering afrezza. When I look at plan details I see no language saying "requiring pre-auth". I assumed if its not a cover drug a pre auth is the process to get it covered and that the 2023 process was the same process for 2024.
The Blue Cross Blue Shield Formulary has this in their commercial plans: AFREZZA INHALATION POWDER 12 UNIT, 4 UNIT,
60X4 &60X8 & 60X12 UNIT, 8 UNIT, 90 X 4 UNIT &
90X8 UNIT, 90 X 8 UNIT & 90X12 UNIT |
| T1 | PA; QL (6 EA per 1 day); AG (Min 18
Years)
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I think what you are talking about is a Formulary Exception which is a lot harder to get. The problem with PA or FE is that they are at the insurers discretion so the insurer can easily clamp down on drugs where there is a theraputic alternative (RAA in this case).
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Post by agedhippie on Oct 29, 2023 8:33:31 GMT -5
The problem for pumps with Afrezza is that it, Afrezza, is also very good, and to my mind, more convenient. Many of us believed that, during those years leading up to approval. Sadly it has turned out that the problem for pumps with Afrezza is virtually nothing. Sure hope that changes one day, but some other things are gonna have to change first. My view remains the same as it was seven years ago - for diabetics needles are largely a non-event, and what sells is anything that lets you reduce your interaction with your diabetes and a pump that ticks that box is compelling. With Afrezza, the point at which you tell me I need to take a follow up dose when I eat to get good numbers is the point where you lose me.
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Post by agedhippie on Oct 28, 2023 11:41:13 GMT -5
Hm. A technology so annoying that users have to take a break from it, more or less on a yearly basis. That doesn't jibe with the notion that users are hesitant to change their routine. It sounds like they do it regularly.
It also sounds like an opening for Afrezza. "Hey, wanna (or hafta) take a pump break? Try Afrezza." There are a lot of users out there who are apparently taking a "pump break."
The problem for pumps with Afrezza is that it, Afrezza, is also very good, and to my mind, more convenient.
I realize there are many other obstacles. Insurance, expense, etc.
Pump breaks are part of the routine. After a few months on a pump you switch to MDI for a month and remember why it was you went on a pump There are a lot of people who take pump breaks, and because they are using RAA they don't need to change how they dose for carbs so it's not much of a change. Switching to Afrezza involves different dosing and the need to do follow ups. That's a block for the adoption of Afrezza. The problem for Afrezza with pumps is that their TIR is far higher than Afrezza. The pump is also more convenient because it automates the whole monitor and correct cycle. I don't need to look at my CGM to decide if I need more insulin, or some carbs because I am going low, as the pump is continuously managing all of that for me. I am being a bit hypocritical here because I don't use a pump, although that looks like it will finally change in the near future. Insurance isn't a big obstacle for commercial insurance plans as a lot have it with pre-auth. It's problematic with Medicare because with the introduction of the co-pay cap insurers cannot recover costs so they are dropping it completely.
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Post by agedhippie on Oct 28, 2023 6:43:09 GMT -5
What happens if UTHR wins, how long would that set back LQDA? If you had to take a guess, what are the odds UTHR wins? If UTHR wins then the patent remains valid and LQDA cannot enter the PAH market until May 2027. Based on historical outcomes from US Court of Appeals for the Federal Circuit PTO appeals UTHR has around a 20% chance of winning. Like much of the legal system it depends on who the judge is.
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Post by agedhippie on Oct 28, 2023 3:17:28 GMT -5
How does it move it up by a couple of months if UTHR loses, as it was set for March 2024 anyways. Do you suggest Liquidia could start selling sooner, or that if the hearing would have been in January, then the March 2024 date would have been delayed? In any case, I don't see a material impact on MNKD in any case as there is enough of a market for a niche player like Liquidia to waddle in. The '793 patent doesn't expire until May 2027. The March 2024 date is the expiry of the PH-ILD exclusivity granted by the FDA and not under dispute. From the market standpoint UTHR is losing a monopoly (why they have been fighting so hard) and it's unclear how LQDA will price Yutrepia. LQDA don't have a profit split like UTHR and MNKD so it's possible they will set their price lower to capture market. The LQDA CEO was the COO and co-CEO of UTHR for 18 years, almost from foundation, so he knows The UTHR play book and how to launch drugs.
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Post by agedhippie on Oct 27, 2023 18:03:06 GMT -5
I’m not sure why the DC circuit court of appeals setting a hearing date for the Liquidia appeal of the District Court decision favoring UTHR would be good news for Liquidia and bad for MNKD and UTHR, as it’s unlikely to reverse the lower federal court decision. I would’ve thought the appeals process risk was already baked into the share prices. stocks.apple.com/Ajr-4JQDpSVuXJYdFMGtBpQMaybe because the LQDA are not appealing the District Court decision? Rather, UTHR is appealing the PTAB decision favoring LQDA to the US Court of Appeals for the Federal Circuit. If UTHR loses their appeal (and most PTAB appeals lose) then the '793 patent becomes invalid and the District Court decision will be set aside since there will no longer be a patent LQDA could infringe. The hearing date in Q4 is considered good because there had been a strong possibility it would have been in Q1/2024. This moves up the Yutrepia launch by a couple of months if UTHR loses.
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Post by agedhippie on Oct 27, 2023 16:47:34 GMT -5
I know two people on pumps very well. One is a veteran at the VA and the VA doctor hasn't heard of afrezza and he is not one to argue or even learn that there are choices (even though i send them info on afrezza all the time). He has used the needle most his life and he is very good and used to doing that. The last two years he has been on the pump and hates it and goes back and forth with the stab and the pump. But, every time I see him he is out of range and needs to eat or give himself a shot. The other one is on the pump and comes close to dying once or twice a yr and always sick. She is also a stubborn person and just won't listen to common sense about using afrezza. Her Dr also is not a fan and she does what Dr says regardless of the damage that she is having. Diabetes is about the long haul and finding a regime you can live with. Once someone has found something they can live with it's extremely hard to move them off it. The fact you could get better results is not the top concern, this is something that people here often miss. I am not selling this as a universal truth, but it's reflected in the diabetes support groups I go to - there are people who are doing things that are definitely sub-optimal but they aren't changing because it's their routine.
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Post by agedhippie on Oct 27, 2023 16:26:18 GMT -5
I don't see the pump switch trial results getting significant numbers to switch permanently. What you may see though is people who take a pump break (after a year or so on a pump people often have a month or three off the pump using MDI) using Afrezza. The problem for Afrezza with pumps is that they are very good, and very convenient. The down side to pumps is that they are convenient because they are attached to you which gets annoying after a while hence pump breaks.
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Post by agedhippie on Oct 27, 2023 16:22:15 GMT -5
... The big obstacle right now is we still need the pre auths in 2024 for Medicare. That takes some work and hand holding but a perfect job for the reps to work with the doctors and DXCM. DXCM alone sure has no interest in doing that. Hoping the India results are great - that could jump start the effort. Having an afrezza/GLP1 study would help a lot. No, the big obstacle right now is that you will not be able to get Afrezza using the three largest insurers for the Medicare 2024 plans even with pre-auth. For pre-auth the drug has to appear in the formulary labeled as requiring pre-auth. If it's not in the formulary then it's not covered and hence pre-auth is not an option.
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Post by agedhippie on Oct 26, 2023 14:39:10 GMT -5
... I think he has a game plan in place to sell Afrezza, but we need to wait for the results of the Afrezza kids trial. Mike is well aware of the problems associated with selling Afrezza and I think that understanding will help a lot in the future. We just need more money to advertise. ... I don't see the kids trials really altering the adult market. What it will do is grow the total market by now including kids. I would expect the increase to be in-line with the market share of the adult market, maybe a bit better if the results are good. The endos still need to see hard data that Afrezza can match the AID pumps they are giving kids right now as those pumps are turning in good numbers with minimal effort. The Type 1 market, which is where Mike sees Afrezza according to the Morgan Stanley conference, is not moved by insulin advertising. To get anywhere with that market you are going to need to get endos to want to prescribe, and insurers to provide cover - those will not be altered by retail adverts, it takes data. It is an incredibly conservative and slow changing market because this is literally people's lives so screwing can be fatal rather than inconvenient. In Medicare the $35 co-pay cap is going to make insurers very reluctant to cover Afrezza. We have already seen the formularies for the three largest Medicare insurers and Afrezza is completely absent. You only get a $35 co-pay cap if the insulin is covered. Next year the list price on Humalog will be $66 list for a vial of insulin. The same amount of Afrezza is 100s of dollars and insurers do not want to eat that difference hence the lack of coverage.
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