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Post by sayhey24 on Jan 8, 2024 17:30:22 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. To answer your first question MNKD-101 Clofazimine DPI, has potential. Mike thinks it significant. We will know better after P 2/3 trials. In other words approval would not be until 3Q2025. The advantage Technosphere provides is it goes directly into the blood and the nasty side effects get bypassed. Its the same thing which MNKD saw when they put GLP1 on technosphere. The nasty side effects got significantly reduced. I think Mike has enough data from preliminary testing that he thinks it will work. I think Mike is right. As PRC says UTHR will probably provide sales and marketing. Its all going to depend on the deal. Right now they are getting 10% on sales of Tyvaso DPI. In this case I would expect 30%. Selling through MNKD's sales force would make no sense to me. |
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Post by prcgorman2 on Jan 8, 2024 17:34:01 GMT -5
It's worth noting what's gone through Phase 1 and will be in the Ph2/3 trial is a nebulized form of Clofazamine (now manufactured by MNKD), not Clofazimine Technosphere (Clof-T). Clof-T will be later (or not at all).
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Post by letitride on Jan 8, 2024 17:49:43 GMT -5
Its not just that clofazimine is inhaled but that the dosage is reduced with considerably fewer side effects.
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Post by uvula on Jan 8, 2024 20:52:45 GMT -5
I don't think there is an efficacy or side effect advantage to DPI over the nebulizer. It is merely a convenience factor. It might not make good business sense ever to convert it to DPI.
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Post by prcgorman2 on Jan 8, 2024 22:41:38 GMT -5
I don't think there is an efficacy or side effect advantage to DPI over the nebulizer. It is merely a convenience factor. It might not make good business sense ever to convert it to DPI. I think you’re correct that there needs to be an advantage to getting a Clof-T version of Clofazimine over the nebulized. There could be several beyond just efficacy and minimization of side effects. |
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Post by letitride on Jan 9, 2024 0:44:09 GMT -5
In consideration that the treatment period is less than 2 months total Im expecting it to stay nebulized.
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Post by sayhey24 on Jan 9, 2024 7:16:30 GMT -5
I don't think there is an efficacy or side effect advantage to DPI over the nebulizer. It is merely a convenience factor. It might not make good business sense ever to convert it to DPI. You are correct and that is a concern of mine. They must be having issues loading this on TS. It makes little sense to go through trials and then turn around and go through the same trials again. By this time we should already have a pilot going on DPI. Maybe that is why UTHR has not already partnered. |
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Post by agedhippie on Jan 9, 2024 8:16:56 GMT -5
In consideration that the treatment period is less than 2 months total Im expecting it to stay nebulized. I agree. They already have the nebulized product so why incur a big delay while they get it onto TS. It's far better to do the trial immediately using the nebulized version and then do equivalence trial to convert to TS. In the interval you have a revenue stream from the approved nebulized version. |
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Post by uvula on Jan 9, 2024 8:28:57 GMT -5
I don't think there is an efficacy or side effect advantage to DPI over the nebulizer. It is merely a convenience factor. It might not make good business sense ever to convert it to DPI. You are correct and that is a concern of mine. They must be having issues loading this on TS. It makes little sense to go through trials and then turn around and go through the same trials again. By this time we should already have a pilot going on DPI. Maybe that is why UTHR has not already partnered. You jump to unsupported conclusions a lot. "They must be having issues... " Where did that come from? It was quicker to nebulizer it so we either get approval (and revenue) faster or we get rejection faster. If the nebulizer drug fails the DPI version would fail also. It might not make sense to ever technospherize it if mnkd makes money on the nebulized drug. |
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Post by prcgorman2 on Jan 9, 2024 8:40:11 GMT -5
What MC has said is get nebulized version of Clofazimine approved and then TechnoSphere version because that’s the fast-track with the FDA. It makes perfect sense. And if the TS version never materialized, should we care? My guess is there are some benefits to the TS version, which may be mostly business benefits, not therapeutic necessarily. Regardless, it’s nebulized for now, and we’ll see what we see later.
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Post by casualinvestor on Jan 9, 2024 8:49:55 GMT -5
If the phase 1 trial work was all nebulized, then it will be faster-to-market with nebulized and that's a good reason not to take a step back and do DPI. IIRC the protocol is one month on and two months off, and once daily? So there's less inconvenience than with Tyvaso-DPI
However, getting another successful drug on Technosphere has merits in the big picture sense
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Post by castlerockchris on Jan 9, 2024 14:20:13 GMT -5
The nebulizer version is faster (less technology questions and more docs comfortable with the delivery) to get through trial and probably less FDA questions in the long run. Get it approved, start the revenue stream, wait for competition to rear its head, then move to a DPI trial, funded by existing nebulizer revenue. If MNKD 101 is approved, by the time MNKD gets to a DPI trial, UTHR's manufacturing facility will be up and running, freeing up MNKD's capacity. Makes sense to me.
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Post by sayhey24 on Jan 9, 2024 15:01:00 GMT -5
The nebulizer version is faster (less technology questions and more docs comfortable with the delivery) to get through trial and probably less FDA questions in the long run. Get it approved, start the revenue stream, wait for competition to rear its head, then move to a DPI trial, funded by existing nebulizer revenue. If MNKD 101 is approved, by the time MNKD gets to a DPI trial, UTHR's manufacturing facility will be up and running, freeing up MNKD's capacity. Makes sense to me. Why would it be faster to get through trials and less FDA questions? I think we already heard from UTHR yesterday how much better the DPI version is. With the delay with the fire that seemed like the perfect time to switch to DPI and not have to rinse and repeat with trials and expenses. |
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Post by agedhippie on Jan 9, 2024 17:03:18 GMT -5
The nebulizer version is faster (less technology questions and more docs comfortable with the delivery) to get through trial and probably less FDA questions in the long run. ... Why would it be faster to get through trials and less FDA questions? ... Because the nebulized version already exists and has cleared Phase 1 so the FDA are familiar with it. The DPI version does not yet exist. |
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Post by sayhey24 on Jan 10, 2024 7:49:27 GMT -5
Why would it be faster to get through trials and less FDA questions? ... Because the nebulized version already exists and has cleared Phase 1 so the FDA are familiar with it. The DPI version does not yet exist. Well - after all this time that Mike has been talking about this and your are saying the DPI version does not exist? If thats true then we have a serious problem. We have a lab which should have been able to make that happen in months and its been years. I think Mike needs to address this. |
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