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Post by hellodolly on Jul 6, 2023 18:38:15 GMT -5
Always wondered about this being converted to DPI when this will be used with a nebulizer in PHII/III not their inhaler. It's not diabetes so I don't pay as much attention as I should. This will be delivered via a nebulizer? What happened to TS? Can't say I know the exact reason why but MC said it several times when he talked about it at the various healthcare conferences. Also, it's how they delivered Clofazimine during the PHI trial. My guess is it's an already approved delivery method and it would take more time to get it converted into a powder for use in an inhaler. That would take different trials thus, longer to market. I think this is low hanging fruit for MNKD. They have already demonstrated lower doses are as effective but have lower toxicity and SAEs. The PHII/III is brief, 6 months (28 day treatment, 60 days off, repeat 28 day treatment, end of treatment). Follow the participants for X months, collect data and report. |
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Post by prcgorman2 on Jul 6, 2023 19:08:19 GMT -5
It's not diabetes so I don't pay as much attention as I should. This will be delivered via a nebulizer? What happened to TS? Can't say I know the exact reason why but MC said it several times when he talked about it at the various healthcare conferences. Also, it's how they delivered Clofazimine during the PHI trial. My guess is it's an already approved delivery method and it would take more time to get it converted into a powder for use in an inhaler. That would take different trials thus, longer to market. I think this is low hanging fruit for MNKD. They have already demonstrated lower doses are as effective but have lower toxicity and SAEs. The PHII/III is brief, 6 months (28 day treatment, 60 days off, repeat 28 day treatment, end of treatment). Follow the participants for X months, collect data and report. And classified as an “orphan drug” by the FDA so there are special Orphan Drug Act incentives for development and marketing. |
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Post by phdedieu12 on Jul 7, 2023 7:53:43 GMT -5
Mnkd cannot manufacture clofazimine. Mnkd cannot produce clofazimine. Doesn't matter what word(s) you want to use. Not a complaint. Just a fact that some people here were aparently not aware of. Point remains, it will be produced like Afrezza and Tyvaso in Danbury instead of Germany, and I see that as a good thing |
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Post by uvula on Jul 7, 2023 9:15:59 GMT -5
Mnkd cannot manufacture clofazimine. Mnkd cannot produce clofazimine. Doesn't matter what word(s) you want to use. Not a complaint. Just a fact that some people here were aparently not aware of. Point remains, it will be produced like Afrezza and Tyvaso in Danbury instead of Germany, and I see that as a good thing The point is still wrong. Before the fire, the clofaz was being made at an outside supplier and then added to technospheres at mnkd. After the fire, the clofaz will still need to come from somewhere other than mnkd and will then be added to technospheres at mnkd. You used afrezza as an example. Mnkd does not make/manufacture/produce insulin. They buy insulin and add it technospheres at mnkd to create afrezza. This is not a negative comment. It is just how things are. Except my comment is somewhat wrong because the clofaz for the clinical trials is nebulized so I don't think it is being combined with technospheres. But it still needs to come from an outside supplier. In the future it probably will be technosphered. |
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Post by agedhippie on Jul 7, 2023 9:21:33 GMT -5
Mnkd cannot manufacture clofazimine. Mnkd cannot produce clofazimine. Doesn't matter what word(s) you want to use. Not a complaint. Just a fact that some people here were aparently not aware of. Point remains, it will be produced like Afrezza and Tyvaso in Danbury instead of Germany, and I see that as a good thing I think you are missing the point. Mannkind could package the API (Clofazimine), but they could not manufacture the API even if they wanted to. There is dependency on a 3rd party to supply the API unless Mannkind wants to branch out into manufacturing the API as well which would be beyond stupid (it's a very cheap drug with lousy margins and would take forever to recoup the plant build out costs.) As hellodolly pointed out to me this is delivered via a nebulizer - Mannkind would need to build manufacturing for a tactical objective when their strategic direction is Technosphere. Far better to work on the feasibility of migrating it to Technosphere as described in the 10K. That will take time though and you could probably use the development of Tyvaso DPI, another nebulizer to TS migration as a guideline for the timescales involved. At the point the TS migration happens (if it happens) then the nebulizer manufacturing plant becomes redundant. In short; moving manufacturing to Danbury before the transition to TS would be a bad thing. |
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Post by phdedieu12 on Jul 7, 2023 9:45:58 GMT -5
Point remains, it will be produced like Afrezza and Tyvaso in Danbury instead of Germany, and I see that as a good thing The point is still wrong. Before the fire, the clofaz was being made at an outside supplier and then added to technospheres at mnkd. After the fire, the clofaz will still need to come from somewhere other than mnkd and will then be added to technospheres at mnkd. You used afrezza as an example. Mnkd does not make/manufacture/produce insulin. They buy insulin and add it technospheres at mnkd to create afrezza. This is not a negative comment. It is just how things are. Except my comment is somewhat wrong because the clofaz for the clinical trials is nebulized so I don't think it is being combined with technospheres. But it still needs to come from an outside supplier. In the future it probably will be technosphered. Yes, the ingredients still need to come from somewhere, but the final product (nubelized or TS version) will be produced in Danbury. I am unsure if the supplier who suffered the fire made the nebulizer or supplied the raw ingredients, but it gives an opportunity for MNKD to remove said supplier and bring that process in house. I find that to be a good thing, others can disagree |
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Post by phdedieu12 on Jul 7, 2023 9:56:59 GMT -5
Point remains, it will be produced like Afrezza and Tyvaso in Danbury instead of Germany, and I see that as a good thing I think you are missing the point. Mannkind could package the API (Clofazimine), but they could not manufacture the API even if they wanted to. There is dependency on a 3rd party to supply the API unless Mannkind wants to branch out into manufacturing the API as well which would be beyond stupid (it's a very cheap drug with lousy margins and would take forever to recoup the plant build out costs.) As hellodolly pointed out to me this is delivered via a nebulizer - Mannkind would need to build manufacturing for a tactical objective when their strategic direction is Technosphere. Far better to work on the feasibility of migrating it to Technosphere as described in the 10K. That will take time though and you could probably use the development of Tyvaso DPI, another nebulizer to TS migration as a guideline for the timescales involved. At the point the TS migration happens (if it happens) then the nebulizer manufacturing plant becomes redundant. In short; moving manufacturing to Danbury before the transition to TS would be a bad thing. Correct, I was not suggesting MNKD would make the API, but bring the process in house (nebulizer). I did assume that the fire affected the vendor providing the nebulizer, not the API, so I could be wrong. While the direction is TS, my understanding is that it is nebulized now, and if memory serves me well, MC did say it would take a bit to get TS version, so why not remove that vendor out of the equation (as I said, bring that process in house)? Time will tell... |
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Post by phdedieu12 on Jul 7, 2023 10:15:29 GMT -5
Mannkind Said On June 26, Was Informed Co's Contract Manufacturer Of Clofazimine Inhalation Solution Experienced Fire In Its Manufacturing Unit. In my opinion, MNKD builds this manufacturing unit and brings the process in house....
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Post by hellodolly on Jul 7, 2023 10:59:55 GMT -5
Mannkind Said On June 26, Was Informed Co's Contract Manufacturer Of Clofazimine Inhalation Solution Experienced Fire In Its Manufacturing Unit. In my opinion, MNKD builds this manufacturing unit and brings the process in house.... Or, we could sign another supply agreement like we did with Amphstar and keep a warehouse full of products. I believe this is the route MNKD is taking at this time. Unfortunately, we already hit a small bump in the road so, your ideas and suggestions are a the very least, thought provoking. Maybe, eventually, if it all pans out and the ROI is positive and MNKD has global sales that indicate they're the #1 provider for the treatment of NTM, then...they may want to explore that option? Better yet, buy the manufacturing company and make it a part of MNKD's Orphan Lung Drug Division. I see the dangers of leaning on someone else to be the sole source provider of these materials. It reminds me of UTHR building out a second manufacturing plant for Tyvaso, DPI. God forbid MNKD has a fire and they don't have the same capabilities as MNKD to make Tyvaso, DPI which brings me to my next point. Manufacturing capabilities and drug supply chain issues are two concerns and therefore, it's obvious what both are important to the overall strategy. It's an internal strength if you have them both covered, if you rely on both...as well, they can be a weakness if you don't. Just my two pennies worth. |
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Post by akemp3000 on Jul 7, 2023 12:28:40 GMT -5
Agree. The greater a drug's potential, the greater the likelihood the primary supplier will eventually own the entire cradle-to-cradle supply chain. This is especially true with drugs going global. The disclosure and forward movement of the next UTHR TS molecule increases this possibility.
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Post by mymann on Jul 19, 2023 14:40:46 GMT -5
Clofazimine for NTB would be a great fit for UTHR pipeline for a pulmonary orphan drug.
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Post by prcgorman2 on Jul 19, 2023 17:12:06 GMT -5
NTM, not NTB.
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Post by bones1026 on Jul 19, 2023 20:41:52 GMT -5
No comments on this topic in two weeks and then a random comment after Mnkd tweets out that their is a poster being presented on clofazmine…it’s almost as if he just wanted to get the “Fire Reported..expect delays” headlines to the top of the list so it’s the first thing you see. |
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Post by akemp3000 on Jul 19, 2023 21:14:59 GMT -5
 What's the point being made? |
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Post by mymann on Jul 19, 2023 22:08:49 GMT -5
National Tires and Batteries. |
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What's the point being made?