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Post by mpg54 on Nov 25, 2023 14:41:19 GMT -5
Curious to know what the board thinks of this drugs potential. Can an orphaned drug not even in use really find new life by being converted to an inhaleable version? How is Mannkind going to sell it? From what little I know I can only imagine huge challenges here. What am I missing?
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Post by prcgorman2 on Nov 25, 2023 15:49:08 GMT -5
Clofazamine is being tested as an orphan drug treatment for Non-Tuberculosis Mycobaceterium. The “orphan drug” classification provides special treatment by the FDA that will be helpful for MannKind to bring the drug to market. The marketing hasn’t been discussed but could be through MannKind’s existing salesforce, or by a marketing partner. I think United Therapeutics stands out as a candidate for marketing a drug to treat lung ailments. NTM is a particularly hard to treat condition so there is significant hope that Clofazamine on Technosphere (Clof-T?) will be a very valuable product.
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Post by mpg54 on Nov 25, 2023 18:46:27 GMT -5
Clofazamine is being tested as an orphan drug treatment for Non-Tuberculosis Mycobaceterium. The “orphan drug” classification provides special treatment by the FDA that will be helpful for MannKind to bring the drug to market. The marketing hasn’t been discussed but could be through MannKind’s existing salesforce, or by a marketing partner. I think United Therapeutics stands out as a candidate for marketing a drug to treat lung ailments. NTM is a particularly hard to treat condition so there is significant hope that Clofazamine on Technosphere (Clof-T?) will be a very valuable product. But what would make it any different from its current form which was apparently unusable today? Going directly to the blood stream I get it, but how is that going to be any better? I would assume the trails would have to have extrodinary results in comparison to its current form for any Sales team to have success with it. |
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Post by Thundersnow on Nov 25, 2023 20:01:39 GMT -5
Clofazamine is being tested as an orphan drug treatment for Non-Tuberculosis Mycobaceterium. The “orphan drug” classification provides special treatment by the FDA that will be helpful for MannKind to bring the drug to market. The marketing hasn’t been discussed but could be through MannKind’s existing salesforce, or by a marketing partner. I think United Therapeutics stands out as a candidate for marketing a drug to treat lung ailments. NTM is a particularly hard to treat condition so there is significant hope that Clofazamine on Technosphere (Clof-T?) will be a very valuable product. But what would make it any different from its current form which was apparently unusable today? Going directly to the blood stream I get it, but how is that going to be any better? I would assume the trails would have to have extrodinary results in comparison to its current form for any Sales team to have success with it. The biggest issue with the drug was the side effects. Once metabolized it was too harsh to tolerate. With the Nebulized/DPI version it bypasses the organs and goes directly into blood stream. Mike has said they are working on formulas whereby the patient takes the drug for 28 days and pauses for 60 days. They are having very positive results. They will fine tune and go into a Phase 2/3 trial next year. |
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Post by mpg54 on Nov 25, 2023 21:51:59 GMT -5
But what would make it any different from its current form which was apparently unusable today? Going directly to the blood stream I get it, but how is that going to be any better? I would assume the trails would have to have extrodinary results in comparison to its current form for any Sales team to have success with it. The biggest issue with the drug was the side effects. Once metabolized it was too harsh to tolerate. With the Nebulized/DPI version it bypasses the organs and goes directly into blood stream. Mike has said they are working on formulas whereby the patient takes the drug for 28 days and pauses for 60 days. They are having very positive results. They will fine tune and go into a Phase 2/3 trial next year. 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. |
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Post by prcgorman2 on Nov 26, 2023 10:39:33 GMT -5
The biggest issue with the drug was the side effects. Once metabolized it was too harsh to tolerate. With the Nebulized/DPI version it bypasses the organs and goes directly into blood stream. Mike has said they are working on formulas whereby the patient takes the drug for 28 days and pauses for 60 days. They are having very positive results. They will fine tune and go into a Phase 2/3 trial next year. 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. Treprostinil Technosphere (Tre-T) (also known as Tyvaso DPI) did not receive a black label despite being specifically questioned in a “citizen petition” which the FDA investigated and dismissed. I won’t try to find it, but there is a post from stevil indicating Clofazamine for NTM would be very valuable. Also, Clofazamine will be nebulized but not initially carried by Technosphere. So if your concern was black label based on the experience of Afrezza, I think you can dismiss it. |
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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 spikespiegel on Jan 8, 2024 7:55:00 GMT -5
Does anyone know whether Thomas Hoffmann still works at Mannkind? Thomas no longer appears on Mannkind's leadership team.
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limo
Researcher
Posts: 82
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Post by limo on Jan 8, 2024 8:14:25 GMT -5
Does anyone know whether Thomas Hoffmann still works at Mannkind? Thomas no longer appears on Mannkind's leadership team. he left / |
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limo
Researcher
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Post by limo on Jan 8, 2024 8:16:55 GMT -5
was trying to post the link to his linkedin profile
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Post by prcgorman2 on Jan 8, 2024 8:26:14 GMT -5
Former CEO QrumPharma, the small company developing Clofazimine that was acquired by MannKind. Not suprised he left. I hope it was on good terms.
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Post by sportsrancho on Jan 8, 2024 10:02:45 GMT -5
was trying to post the link to his linkedin profile |
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Post by sportsrancho on Jan 8, 2024 10:03:05 GMT -5
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Post by sportsrancho on Jan 8, 2024 10:03:21 GMT -5
That’s weird it won’t post
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Post by porkini on Jan 8, 2024 16:52:29 GMT -5
was trying to post the link to his linkedin profile Weird that this link is not posting. I tried various things, the only thing I came up with was use a DuckDuckGo search and click on the first link with Aumapharma: link |
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