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Post by agedhippie on Dec 1, 2023 16:13:36 GMT -5
On November 30, 2023, United Therapeutics filed an amended complaint in the District Court adding allegations that the Company infringes the ’327 Patent as a result of its amendment to add the PH-ILD indication to the label for YUTREPIA. on June 29, 2023, United Therapeutics Corporation (“United Therapeutics”) received a notice of allowance with respect to its patent application number 17/233,061, the claims of which generally cover the treatment of patients having pulmonary hypertension associated with interstitial lung disease (“PH-ILD”) through the inhaled administration of treprostinil. On November 28, 2023, a new patent, U.S. Patent No. 11,826,327 (the “’327 Patent”) was issued from that patent application. From form 8-k The LQDA response: www.streetinsider.com/SEC+Filings/Form+8-K+Liquidia+Corp+For%3A+Nov+30/22479032.htmlThis is the relevant bit: Because neither the ’793 Patent nor the ’327 Patent was issued prior to the filing of the original NDA for YUTREPIA, we believe United Therapeutics is not entitled to a statutory 30-month stay with respect to either of these patents.UTHR have the same problem as with their standalone lawsuit for '327, it wasn't in the Orange book when LQDA made their filing for PH-ILD. That means it isn't covered by the Hatch Waxman Act since that requires the patent to be in the Orange book when the filing is made (the Act set up the Orange book specifically to clarify what was and wasn't covered.) On the face of it I don't think UTHR has a case, but then I am not a lawyer and I long ago gave up being surprised by what the courts will do.
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Post by agedhippie on Nov 29, 2023 17:52:48 GMT -5
Aged, I'm having trouble with the December 4th oral argument UTHR vs LQDA link you sent a while ago. When I go to it, it's just a blank page sort of Can you post the specific link to listen to the argument? Do you know what time it will be? I am not sure which link that was, but I think this is what you are after - cafc.uscourts.gov/home/oral-argument/listen-to-oral-arguments/They stream it live and post a recording at the end of the day as well. There is an archive of past recordings you can search as well.
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Post by agedhippie on Nov 28, 2023 9:20:26 GMT -5
The very positive results Mike has mentioned will be interesting, crossing my fingers. To sell it they need to be convincing and without another black label. I do not see black box warnings as being a big deal. There are a ton of drugs with them, including Ozempic, and it doesn't seem to harm their sales. On top of that there are not a lot of alternatives with orphan drugs by definition so it weighs even less. Even drugs like Reglan that have black box warnings on permanent nerve damage which a very high probability past 12 weeks get used regularly (actually it is part of the SoC for gastroparesis.)
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Post by agedhippie on Nov 28, 2023 9:07:26 GMT -5
I’ll argue that Afrezza resembles the “first phase insulin secretion” and in so doing signals the liver to reduce (or stop?) creating glucose from fat. Am I wrong? You are correct, except that the liver has it's own store of glucose which it maintains and draws on rather than creating it from fat. You see this reserve talked about most often in the context of a glucose dump when your liver responds to glucagon or adrenaline.
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Post by agedhippie on Nov 25, 2023 12:38:36 GMT -5
I wish someone would write a rebuttal! It was a bit of a disappointment. I quite like LFD's articles because they present another view that I might disagree with, but which has some sort of point to consider. This one - not so much. LFD desperately needs an editor to structure his articles. His entire article could be summarized as: - Afrezza is in the doldrums - V-Go is deadweight - UTHR will unhesitatingly screw over MNKD to improve their margins to compete with Merck and LQDA. - Clofazimine is nasty and the FDA will probably make MNKD do analysis on the impact on the lungs - If your product is dry powder then using a nebulizer for your new product isn't a great advert. - With the wrap up that this is going to lead to cash problems for MNKD. My read is that it's a statement of the obvious. Yes Afrezza is in the doldrums, and V-Go as a product is going nowhere but anyone can see that (Mike has made the argument though that V-Go was also about buying an established sales organization.) A proper analysis of the competitive landscape for UTHR in the PAH/PH-ILD market would have been good, but instead we got a grab bag of random facts presented as a case. Clofazimine is undoubtably nasty, but that is what MNKD is attempting to address. I will wait for the trial results to see if inhaling Clofazimine addresses the systemic issues. I do agree that the FDA may want to know more about the impact on the lungs given the impact on skin (this was probably the only bit I thought was interesting). The nebulizer argument sort of has a point. It feels like they are using a nebulizer because that's what all the work to date has been done using and they don't want to switch. The argument about crystals clogging the lings is bizarre given how Technosphere works. That's an initial thought on a very long winded article. Ideal that should have been three separate article for clarity made up of the first two points, the third point, and the fourth point.
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Post by agedhippie on Nov 22, 2023 15:40:32 GMT -5
Reread the section more slowly. Here it is: The biggest issue was it was too much work to babysit their CGM with Afrezza. They got excellent results- they admitted as much. They just got tired of having to dose so many times a day when they could get 0.4-0.5% higher A1c with less than half the effort.No mention of GLP-1 anywhere. This is entirely around what I frequently comment on, and both Bill and Stevil have raised as well. People (including me) don't want to put the level of effort into managing their diabetes that you expect them to. They would rather just dose once, ignore their CGM, and live with the slightly worse results. There is no other drug involved. Aged - as I framed my question to Stevil "our patients were seeing a 0.4-0.5% lower A1c when using afrezza than using what - Mounjaro?" Immediately after this he starts talking about Mounjaro and how he has many patients using it. Lets let Stevil answer what he is comparing afrezza to. ... Read the passage like an English comprehension test. It's crystal clear.
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Post by agedhippie on Nov 22, 2023 15:34:18 GMT -5
I don't have diabetes, but I can't imagine having a pump to wear all day being less of a hassle then a quick inhale when needed. The pump seems like a much bigger management issue. If I did have diabetes I know I would much prefer a CGM and Afrezza as it seems so much less burdensome. I can't speak from actual experience, but I know what would be my choice if I did have to make it. There might be times when I'd inhale in the mens room rather than in public, but if I had to inhale in public that wouldn't be an issue for me personally. I don't like saying this, but that's because you haven't been a diabetic for decades. My experience was that in the early days I was all over it - I checked a lot, I watched what I ate, I always prebolused, and I did corrections. A couple of decades later I only check at meal times, I don't pre-bolus, and corrections never happen except for bed time. Most of that has happened over the last 10 years (strangely, almost parallel to my time on this board ). I did this because I wanted to have less to do with my diabetes and if the price was higher numbers I could live with that if it meant avoiding diabetic burnout. If I used an AID pump my numbers would be way better than they are at the moment, but although I have used a pump in the past it's not something I am keen on. That said I am seriously considering the Omnipod 5 if I can just slap it on and more or less forget about diabetes between meals. The plus to an omnipod is that the running cost is high, but the upfront cost is zero so I can drop it if I can't get on with it with a clear conscience (tubed pumps cost in the thousands). I never criticize a diabetic's choice provided it was a considered decision. I have seen people make choices I strongly disagree with, but it's their decision to make and not mine - we all make our own deal with this particular devil reflecting what we can and cannot live with. Taking insulin in public very rapidly becomes something you see as other peoples' problem
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Post by agedhippie on Nov 22, 2023 15:16:19 GMT -5
From Bill… “In answer to Mango, we used the various discount programs that were available. Ultimately it led us to Eagle and the $99-$199 monthly cost. We were in regular conversation with MannKind Cares and they helped but still patients eventually found the cheapest route was the specialty pharma like Eagle. And that was still too high for many patients, especially when the alternatives were essentially free.” Great info. So the $99 a month is still too high for many patients. I wonder if MannKind could renegotiate to say, $50 a month or even $25 a month through Eagle if that would help. I’m assuming many of these patients are low income/poverty and that $99 a month is a lot for them. We have to do better! For context; with commercial insurance I pay a flat $100 per quarter for Humalog pens regardless of quantity. I would need at least two boxes of Afrezza per month which, I suspect, is not atypical - so $100 vs. $600 with Eagle per quarter or an extra $2,000 per year to use Afrezza.
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Post by agedhippie on Nov 22, 2023 14:55:13 GMT -5
Stevil - are you breaking major news here? Did you just say your patients were seeing a 0.4-0.5% lower A1c when using afrezza than using what - Mounjaro? I am not sure what you are comparing afrezza to but if its GLP1s that is HUGE news. Can you clarify, please. ... Reread the section more slowly. Here it is: The biggest issue was it was too much work to babysit their CGM with Afrezza. They got excellent results- they admitted as much. They just got tired of having to dose so many times a day when they could get 0.4-0.5% higher A1c with less than half the effort.No mention of GLP-1 anywhere. This is entirely around what I frequently comment on, and both Bill and Stevil have raised as well. People (including me) don't want to put the level of effort into managing their diabetes that you expect them to. They would rather just dose once, ignore their CGM, and live with the slightly worse results. There is no other drug involved.
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Post by agedhippie on Nov 21, 2023 9:25:30 GMT -5
... What defense are you coming to Aged's rescue on? The fact that he/she for years said afrezza would cause serious lung damage? That Print will perform better than Technosphere? ... This is a good example why people don't like discussing things with you. "What defense are you coming to Aged's rescue on?" This is a good example of what Stevil was talking about. He said he came to my defense but said nothing about rescue and one does not imply the other. In this context rescue was just sniping which you do a lot. "The fact that he/she for years said afrezza would cause serious lung damage?" No he did not, he just gave up correcting you because you refuse to listen. I have just debunked this statement literally days ago and yet here you are repeating the same stuff yet again. "That Print will perform better than Technosphere?" Where exactly did I say that? This is a good example of you making stuff up. This sort of attack on the person rather than the argument devalues your points because it appears personal. Long term board members probably understand it's how you are and make allowances, but for everyone else it doesn't look good.
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Post by agedhippie on Nov 20, 2023 9:31:34 GMT -5
I have been here longer Although not 66%.... Aged - how come when I look at the last time you logged in it was 2017? How did you post 5554 times and never log in? Maybe I never logged out
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Post by agedhippie on Nov 20, 2023 9:29:03 GMT -5
Tyvaso-DPI undoubtably is more more efficient in delivering the drug to the blood stream. It's just a matter of comparing the LQDA poster where they map cartridges to Tyvaso nebulizer breaths since both companies publish that information. The side effects come from the absorbed drug, not the quantity of drug given - if the drug never makes it into the system then it can't cause side effects. I do agree though that UTHR will get the bulk of the market and have always said so. From LQDA's point of view they don't need the whole market, I doubt they could even supply it, they just need a share. The lung depth images at the top of the slide are based on Exubera rather than LDQA so not really relevant. Aged, I would include effects like cough and throat irritation as side effects, or adverse events (AE's), even though they are not a result of the drug making "it into the system," by which I assume you mean blood stream. These AE's might be more attributable to the carrier rather than the amount of active, although generally the more active that is required, the more carrier is needed to deliver it. I think of it this way: if I take a huge hit of a cigarette or joint (in a state where that's legal lol), I might cough. If it's a smaller hit, then maybe not. If a smaller "hit" of Tyvaso DPI is needed versus Yutrepia, then we might see less coughing, throat irritation, etc. The published studies on the two competing products bear this out. The Inspire study (Yutrepia) for tolerability is here: www.ncbi.nlm.nih.gov/pmc/articles/PMC9400582/ . The published Breeze study (Tyvaso DPI) is here: www.ncbi.nlm.nih.gov/pmc/articles/PMC9063953/ . Check out the tables in the studies. Looks like significantly less coughing and throat irritation for Tyvaso DPI (as well as the rest of the AE's). Nevertheless, the studies show that Tyvaso DPI and Yutrepia were both highly preferred by patients over admin of Tyvaso via nebulizer. There's no denying that Yutrepia can take some market share if it becomes available. Carrier volume isn't usually an issue as they simply make the API more concentrated (or weaker) to reach the volume they are after. Insulin is an example of this, it comes in 1x 2x and 5x strengths to optimize the volume - the 5x insulin is used for people with bad insulin resistance who can use most of a pen in a single shot for a meal. My suspicion is that LQDA would be perfectly happy with just some market share. They also have a nebulized delayed release Tyvaso from a licensing deal, L606, in phase 3 trials as their follow on but that doesn't finish phase 3 until mid 2025. TBH if I was UTHR I would worry far more about Merck and Sotatercept although that really depends on how Merck prices it.
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Post by agedhippie on Nov 19, 2023 19:11:46 GMT -5
Nov 09,2023 06:06AM Liquidia Technologies (LQDA – Research Report), the Healthcare sector company, was revisited by a Wall Street analyst today. Analyst Andreas Argyrides from Wedbush remains neutral on the stock and has a $3.00 price target. Andreas Argyrides gave his Sell rating based on several factors related to Liquidia Technologies. One of the major concerns was the ongoing patent litigation with United Therapeutics, which has added another layer of uncertainty to the company’s operations. This legal battle has resulted in a 30-month stay on the final approval of Liquidia’s main pharmaceutical product, YUTREPIA. The outcome of this lawsuit could heavily impact Liquidia’s ability to successfully enter the market with its products. Another contributing factor to the Sell rating is the potential competitive disadvantage YUTREPIA may face if it receives final approval and becomes available in the U.S. Argyrides notes that Tyvaso DPI, a product of United Therapeutics, has a significant first-mover advantage in the same medical areas YUTREPIA is targeting, coupled with YUTREPIA’s lack of meaningful differentiation. Furthermore, Andreas Argyrides expressed concern over the company’s financial health. With only about a year of cash left, Liquidia may need to raise additional capital to support a competitive YUTREPIA launch, which can add further risks. He doesn't have much of a track record and he's taking a gamble. All the other analysts are between $15.00 and $18.00 and also reviewed after the last call. For his view to come true UTHR must win the appeal, otherwise he is toast. As I said before though, UTHR will own the bulk of the market and all LQDA needs is a share. He is right though that LQDA will do a raise when they win the case, they would be idiots not to because the price will spike and they don't have a big float. The analysts will have factored that into their pricing. The first mover advantage was why UTHR threw everything but the kitchen sink at LQDA to slow them down. UTHR could not afford to be beaten to the market. But LQDA is not UTHR; it doesn't need to dominate the market because the share price will not be hammered for being second, UTHR would have been though.
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Post by agedhippie on Nov 19, 2023 12:21:51 GMT -5
These slides Harry posted some time ago (thank you Harry!) compare Tyvaso DPI and Yutrepia head to head. See mnkd.proboards.com/post/247614/thread . Sure looks the patient gets the same therapeutic effect with significantly less Tyvaso DPI than Yutrepia. Nearly all prescription medicines have side effects, and those side effects normally increase with increasing dose size. That Tyvaso DPI can be dosed in smaller amounts seems like a huge advantage to me. Afrezza is somewhat of an exception to this rule because, unlike treprostinil, it's not a patented molecule invented by big pharma in a lab. It's human insulin whose exclusivity (patent protection) arises from the TS platform for delivery. But yea, if Yutrepia makes it to market, it will reduce Tyvaso DPI sales and likely put some cost pressure on Tyvaso DPI. The extent of that remains to be seen. My money is on UTHR and Martine. Thank you Martine! Tyvaso-DPI undoubtably is more more efficient in delivering the drug to the blood stream. It's just a matter of comparing the LQDA poster where they map cartridges to Tyvaso nebulizer breaths since both companies publish that information. The side effects come from the absorbed drug, not the quantity of drug given - if the drug never makes it into the system then it can't cause side effects. I do agree though that UTHR will get the bulk of the market and have always said so. From LQDA's point of view they don't need the whole market, I doubt they could even supply it, they just need a share. The lung depth images at the top of the slide are based on Exubera rather than LDQA so not really relevant.
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Post by agedhippie on Nov 18, 2023 11:40:17 GMT -5
This is why aged is one of my favorite posters, and you are my least favorite poster. It really boils down to truthiness. Tyvaso is a much more effective treatment than Yutrepia for PAH and ILD. Simple...deep lung (Tyvaso) vs shallow lung (Yutrepia) affect. [blush] There is a lot of misunderstanding around deep lung vs shallow lung. The depth of penetration is primarily decided by the particle size (which is why diesel exhaust is so dangerous) rather than anything else (velocity also plays a part, but to a lesser extent). The problem with inhalers is that you can have a small particle size, but if the particles clump then they become big particles and settle in the upper airways. What the Dreamboat does is breaking up those clumps using turbulent flow, hence small particles, hence deep lung reach. This is not unique to the Dreamboat and there is a whole branch of engineering dedicated to dry powder inhalers. That's a long winded way of saying Yutrepia also has a deep lung effect, as do all inhalers designed for this purpose.
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