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Post by Clement on Jul 12, 2019 8:56:30 GMT -5
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Post by agedhippie on Jul 12, 2019 8:59:41 GMT -5
This is the deal. Most people know when an allergic reaction is approaching. Usually they have about 20 minutes from onset to full blown stop breathing unconsciousness. So it's that 20 minutes that MNKD's EPI HALE will fit with their CRICKET Device. Just imagine the cost savings. MNKD could charge $100 bucks vs $600 for an EPI Pen. If insurance is involved it could be as low as $50 to the patient. That's a HOMERUN for MNKD because the production cost will be minimal. HUGE MARGINS. And you will have less fear of patients JABBING a PEN into their thigh every time. I see huge market potential. Yes, and I remember when people argued that fear of needles would lead to fast and massive acceptance of Afrezza. Time alone will tell if Epi is coming to Mannkind, and whether it proves to be a game changer. The issue is that there are far cheaper alternatives today, but there is a shortage of Epipens, why is that? For the same reason that Afrezza hit headwinds, in a high risk treatment people stick with what they are familiar with. If you look at the stories around the shortage you see that there is a common theme - people want Epipens because it's what they know and trust. Do you really want to have another run at educating the market? Now if you can find a sucker partner who will fund the project then by all means go for it, revenue is revenue.
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Post by lennymnkd on Jul 12, 2019 9:05:11 GMT -5
Same attitude you had with CGM’s going back / just your nature 🤔hmmm
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Post by agedhippie on Jul 12, 2019 9:15:19 GMT -5
Same attitude you had with CGM’s going back / just your nature 🤔hmmm Not sure who that was aimed at. If it was me I have always been in favor of CGMs. The clinic I go to puts you on a pump and CGM at diagnosis if you are a T1. Now CGMs for T2 is going to be a much bigger challenge as the insurers are fighting that one tooth and nail. Interestingly Belgium which has the highest coverage of CGMs, they are free to T1 on demand, has 80% coverage and has been stuck there for a few years now despite their efforts to get higher adoption. It seems there is a percentage who flat out don't want them (and I bet that is reflected in their pump use as well), and this is before you look at the number of people who have them and don't use them or only them very intermittently. I am not sure any of that is relevant, but I found it interesting.
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Post by hellodolly on Jul 12, 2019 9:43:17 GMT -5
"We are also pursuing opportunities to utilize our lyophilization capacity to fulfill the needs of our industry and drug development partners," stated Joe Kocinsky, Chief Technology Officer of MannKind." Could this be more than UTHR when it's in plural form? Are the hinting or slipping, that they are pursuing partners who are interested in the process for other drugs to be manufactured using this process, besides MNKD?
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Post by rtmd on Jul 12, 2019 9:52:46 GMT -5
"We are also pursuing opportunities to utilize our lyophilization capacity to fulfill the needs of our industry and drug development partners," stated Joe Kocinsky, Chief Technology Officer of MannKind." Could this be more than UTHR when it's in plural form? Are the hinting or slipping, that they are pursuing partners who are interested in the process for other drugs to be manufactured using this process, besides MNKD? To me it sounds like he's just saying Mannkind has available unused freeze drying capacity and would like to find customers for that capacity.
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Post by matt on Jul 12, 2019 10:22:11 GMT -5
This looks like a required segregation of manufacturing lines. Depending on the drugs, the formulation and filling lines have to be segregated into different production suites and with some drugs that carry a known risk for anaphylaxis (such as penicillin) the production suites can't even be in the same building as other drugs due to the risk of cross-contamination. Since MNKD had an obligation to do trial quantities of TreT, that is probably all this announcement means.
As for tadalafil and its cousin sildenafil, these are both phosphodiesterase-5 inhibitors. The drugs were developed originally for treating hypertension, not for erectile dysfunction, but during clinical trials of sildenafil a surprising side effect was seen and thus Viagra was born (the drug was abandoned for the hypertension indication at that time). However, PDE-5 inhibitors have a role to play in controlling hypertension as well and Pfizer markets both Viagra and Revatio with Viagra indicated for erectile dysfunction and Revatio for pulmonary hypertension although the active ingredient is the same (Cialis also has a lower dose daily pill for hypertension). It makes perfect sense to deliver tadalafil in an inhaled form as the desired PK/PD for hypertension are quite different than for the more well-known use.
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Post by rtmd on Jul 12, 2019 10:59:42 GMT -5
This looks like a required segregation of manufacturing lines. Depending on the drugs, the formulation and filling lines have to be segregated into different production suites and with some drugs that carry a known risk for anaphylaxis (such as penicillin) the production suites can't even be in the same building as other drugs due to the risk of cross-contamination. Since MNKD had an obligation to do trial quantities of TreT, that is probably all this announcement means. As for tadalafil and its cousin sildenafil, these are both phosphodiesterase-5 inhibitors. The drugs were developed originally for treating hypertension, not for erectile dysfunction, but during clinical trials of sildenafil a surprising side effect was seen and thus Viagra was born (the drug was abandoned for the hypertension indication at that time). However, PDE-5 inhibitors have a role to play in controlling hypertension as well and Pfizer markets both Viagra and Revatio with Viagra indicated for erectile dysfunction and Revatio for pulmonary hypertension although the active ingredient is the same (Cialis also has a lower dose daily pill for hypertension). It makes perfect sense to deliver tadalafil in an inhaled form as the desired PK/PD for hypertension are quite different than for the more well-known use. Would the inhaled version be any more effective than the pill? UTHR hasn't been having much luck with the pill: "United noted in its most recent annual filing that during the four months from when the generic launched until December 2018, the average number of Adcirca bottles sold to distributors decreased more than 55% compared to the same period a year prior." The generic referred to came from Mylan, and I see that Teva just launched its own generic adcirca just a few months ago. Would there be any profit margin for an inhaled version?
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Post by peppy on Jul 12, 2019 11:01:48 GMT -5
"We are also pursuing opportunities to utilize our lyophilization capacity to fulfill the needs of our industry and drug development partners," stated Joe Kocinsky, Chief Technology Officer of MannKind." Could this be more than UTHR when it's in plural form? Are the hinting or slipping, that they are pursuing partners who are interested in the process for other drugs to be manufactured using this process, besides MNKD? here is what caught my eye. Some of the typical pharmaceutical products that would undergo lyophilization include bulk pharmaceutical/biopharmaceutical ingredient (chemical or biologics found in nature), protein, collagen, peptide, oligonucleotide, chemical API, enzymes, and mAbs.
I am amazed at how many mABs commercials I see. Treating everything. arthritis, I saw eczema being treated with mABs commercial this morning. mABs used in oncology. Subcutaneous Administration of Monoclonal Antibodies in Oncology Technosphere and the dreamboat a Route of Administration. www.ncbi.nlm.nih.gov/pmc/articles/PMC4078128/
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Post by rtmd on Jul 12, 2019 11:14:35 GMT -5
"We are also pursuing opportunities to utilize our lyophilization capacity to fulfill the needs of our industry and drug development partners," stated Joe Kocinsky, Chief Technology Officer of MannKind." Could this be more than UTHR when it's in plural form? Are the hinting or slipping, that they are pursuing partners who are interested in the process for other drugs to be manufactured using this process, besides MNKD? here is what caught my eye. Some of the typical pharmaceutical products that would undergo lyophilization include bulk pharmaceutical/biopharmaceutical ingredient (chemical or biologics found in nature), protein, collagen, peptide, oligonucleotide, chemical API, enzymes, and mAbs.
I am amazed at how many mABs commercials I see. Treating everything. arthritis, I saw eczema being treated with mABs commercial this morning. mABs used in oncology. Subcutaneous Administration of Monoclonal Antibodies in Oncology Technosphere and the dreamboat a Route of Administration. A quick google suggests inhaled mabs might be useful for treating local lung disease but apparently they are not well absorbed into the systemic circulation: www.ncbi.nlm.nih.gov/pubmed/25451545
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Post by peppy on Jul 12, 2019 11:18:03 GMT -5
here is what caught my eye. Some of the typical pharmaceutical products that would undergo lyophilization include bulk pharmaceutical/biopharmaceutical ingredient (chemical or biologics found in nature), protein, collagen, peptide, oligonucleotide, chemical API, enzymes, and mAbs.
I am amazed at how many mABs commercials I see. Treating everything. arthritis, I saw eczema being treated with mABs commercial this morning. mABs used in oncology. Subcutaneous Administration of Monoclonal Antibodies in Oncology Technosphere and the dreamboat a Route of Administration. A quick google suggests inhaled mabs might be useful for treating local lung disease but apparently they are not well absorbed into the systemic circulation: www.ncbi.nlm.nih.gov/pubmed/25451545MNKD has mAB patents.
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Post by me on Jul 12, 2019 11:29:06 GMT -5
Very possible, I’ve just had a lot of personal experience with people that have had it happen..my ex-husband, a roommate, the wife of a friend. Of course statistically that’s not saying much it’s just my own experience. I think a bigger problem would be getting docs to prescribe it. How do you explain to a malpractice jury that you prescribed an inhaled drug to treat an ailment whose hallmarks are airway constriction and difficulty breathing? rtmd, are you kidding me??? Have you never heard of an asthma inhaler???
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Post by me on Jul 12, 2019 11:37:54 GMT -5
Hello. Ever heard of asthma? I have...and have had it for 47 years. It's pretty much a disease that is ALL ABOUT a person's inability to breathe. What happens when you have a severe attack and breathe? You take your inhaler. Come on. Is there as effective an alternate rescue medication available for ashtma in this case? If there is no other good option, you have to use what is available. plytle, I saw your post just after I posted above - the point is spot on.
mnkdfann, the point was not whether there were options available, but rather rtmd implied it would be a malpractice risk to prescribe an inhaled medication for "an ailment whose hallmarks are airway constriction and difficulty breathing." Care guidelines for asthma illustrate the silliness of that claim.
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Post by me on Jul 12, 2019 11:39:33 GMT -5
On goodrx, generic cialis sells for $25 for 30 tabs. Per the label, onset of action is within 30 minutes. I don't see where it would be all that profitable to develop an inhaled version. Are you kidding? I would rather inhale and have an erection within 60 seconds vs 30 Minutes. Talk about a mood killer. And MEN will pay a premium for a 60 sec HARDON. The only issue would be discreteness and noise. If I'm paying for a hardon, it better last damn longer than 60 seconds!
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Post by jred on Jul 12, 2019 11:51:54 GMT -5
The generic referred to came from Mylan, and I see that Teva just launched its own generic adcirca just a few months ago. Would there be any profit margin for an inhaled version?
Don't believe UTHR has any plans for an inhaled version of Adcirca. CEO Martine Rothblatt has said that Adcirca is among the 1st generation treatments and they are focused on the 2nd generation. Tyvaso is their initial focus on the Technosphere platform and they already have negotiated options on their deal with ARNA for an inhaled Ralinepag. These two are where UTHR sees its growth and is banking the future on.
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