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Post by sayhey24 on Jan 23, 2023 14:56:23 GMT -5
With successful trials and even pending submittal and approval with a nebulizer, it should be much easier to convert to TS and inhalation. The FDA now appears to be up to speed on the technology Al Mann promoted so it shouldn't be as difficult as in the past. IMO, the nebulizer path may never reach the market for Clofazimine. Granted the word "should" doesn't always carry weight with the FDA. Just thinking this positions the company quite well for the next major TS partnership discussions. From the paper - While alternative manufacturing methods, such as spray drying, can improve aqueous solubility by creating particulates that can be administered either orally or by inhalation (14), we instead took advantage of the unique crystalline nature of CFZ. In a liquid formulation, the phagocytic uptake of CFZ crystals by monocytes appears to be a unique, but natural, means to control systemic distribution outside the lung (15). We undertook a development process to reformulate CFZ into an inhaled dose formulation that could effectively deliver CFZ directly to the lung, while reducing the systemic toxicity seen in oral dosing. Our efforts to reformulate unmodified clofazimine have resulted in a novel aerosolizable liquid formulation (clofazimine inhalation suspension [CIS or MNKD-101]) that can be delivered to the lung using a standard mesh or jet nebulizer (16). To be honest, I really don't care if this is an aerosol or a DPI as long as Mike can get 10% of a market which is some where between $3.5B to 10B. |
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Post by hopingandwilling on Jan 23, 2023 15:08:27 GMT -5
<< First acquisition for MC looks like a good one, and no partners! We get to keep it all.>>>
With what appears to be the case that MNKD is the first company to enter human clinical trials, would you think that should anyone else want to do clinical trials using clofazimine for this indication, they would be treated differently that how they are dealing with MannKind?
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Post by mango on Jan 23, 2023 15:15:48 GMT -5
With successful trials and even pending submittal and approval with a nebulizer, it should be much easier to convert to TS and inhalation. The FDA now appears to be up to speed on the technology Al Mann promoted so it shouldn't be as difficult as in the past. IMO, the nebulizer path may never reach the market for Clofazimine. Granted the word "should" doesn't always carry weight with the FDA. Just thinking this positions the company quite well for the next major TS partnership discussions. From the paper - While alternative manufacturing methods, such as spray drying, can improve aqueous solubility by creating particulates that can be administered either orally or by inhalation (14), we instead took advantage of the unique crystalline nature of CFZ. In a liquid formulation, the phagocytic uptake of CFZ crystals by monocytes appears to be a unique, but natural, means to control systemic distribution outside the lung (15). We undertook a development process to reformulate CFZ into an inhaled dose formulation that could effectively deliver CFZ directly to the lung, while reducing the systemic toxicity seen in oral dosing. Our efforts to reformulate unmodified clofazimine have resulted in a novel aerosolizable liquid formulation (clofazimine inhalation suspension [CIS or MNKD-101]) that can be delivered to the lung using a standard mesh or jet nebulizer (16). To be honest, I really don't care if this is an aerosol or a DPI as long as Mike can get 10% of a market which is some where between $3.5B to 10B. I agree! At the end of the day, getting the product approved and out to patients in a market with no real competition, and where we will have exclusivity for many years—this could be a pretty incredible as far as revenue generating potential, especially if we are going at this solo. I wonder which nebulizer manufacturer we are using? |
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Post by mango on Jan 23, 2023 15:30:55 GMT -5
I think it was Looking For Diogenes who wrote a hit piece a while back spreading fear, uncertainty and doubt when MannKind announced they were pursuing Clofazimine. I remember he/she/they really hammered in on the potential side effects and skin discoloration.
It was very nice seeing how none of those issues fear mongered by LFD have even come close to raising alarms.
So far in beagles and health human volunteers, absolutely zero safety signals associated with usual side effects and no skin discoloration associated with MannKind’s inhaled clofazimine
I believe this has been one of the primary reasons MC has been so excited about this formulation and route of administration. Could be a real game changer!
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Post by peppy on Jan 23, 2023 15:35:34 GMT -5
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Post by thekid2499 on Jan 23, 2023 16:51:48 GMT -5
One reason I enjoy this board is that it provides important educational background and updates for items like this. It remains puzzling as to how anyone could interpret progress achieving desired results as "horrible news". IMO, the path from nebulizers and dogs would seem to be a foundational requirement for a path to inhalation and humans. Others know more about this. The guy clearly has an agenda - just take 5 minutes and read through his posts. Pretty obvious. |
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Post by prcgorman2 on Jan 23, 2023 17:04:40 GMT -5
One reason I enjoy this board is that it provides important educational background and updates for items like this. It remains puzzling as to how anyone could interpret progress achieving desired results as "horrible news". IMO, the path from nebulizers and dogs would seem to be a foundational requirement for a path to inhalation and humans. Others know more about this. The guy clearly has an agenda - just take 5 minutes and read through his posts. Pretty obvious. Took 5 minutes. What is the agenda? |
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Post by sayhey24 on Jan 23, 2023 18:17:36 GMT -5
From the paper - While alternative manufacturing methods, such as spray drying, can improve aqueous solubility by creating particulates that can be administered either orally or by inhalation (14), we instead took advantage of the unique crystalline nature of CFZ. In a liquid formulation, the phagocytic uptake of CFZ crystals by monocytes appears to be a unique, but natural, means to control systemic distribution outside the lung (15). We undertook a development process to reformulate CFZ into an inhaled dose formulation that could effectively deliver CFZ directly to the lung, while reducing the systemic toxicity seen in oral dosing. Our efforts to reformulate unmodified clofazimine have resulted in a novel aerosolizable liquid formulation (clofazimine inhalation suspension [CIS or MNKD-101]) that can be delivered to the lung using a standard mesh or jet nebulizer (16). To be honest, I really don't care if this is an aerosol or a DPI as long as Mike can get 10% of a market which is some where between $3.5B to 10B. I agree! At the end of the day, getting the product approved and out to patients in a market with no real competition, and where we will have exclusivity for many years—this could be a pretty incredible as far as revenue generating potential, especially if we are going at this solo. I wonder which nebulizer manufacturer we are using? The paper says "can be delivered to the lung using a standard mesh or jet nebulizer (16)". I would go with the best value. If they can load it on TS, all the better. That inhaler can't cost more than a few cents. I sure hope Mike negotiates a great deal with UTHR to sell the product. They have the sales reps and know the doctors and industry. I would hate to have the same sales success as we have had with afrezza. |
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Post by ryster505 on Jan 23, 2023 18:20:22 GMT -5
I agree! At the end of the day, getting the product approved and out to patients in a market with no real competition, and where we will have exclusivity for many years—this could be a pretty incredible as far as revenue generating potential, especially if we are going at this solo. I wonder which nebulizer manufacturer we are using? The paper says "can be delivered to the lung using a standard mesh or jet nebulizer (16)". I would go with the best value. If they can load it on TS, all the better. That inhaler can't cost more than a few cents. I sure hope Mike negotiates a great deal with UTHR to sell the product. They have the sales reps and know the doctors and industry. I would hate to have the same sales success as we have had with afrezza. To think no lessons have been learned by MC during his tenure so far would be naive. Then again wouldn’t surprise me coming from you. |
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Post by sayhey24 on Jan 23, 2023 18:42:16 GMT -5
The paper says "can be delivered to the lung using a standard mesh or jet nebulizer (16)". I would go with the best value. If they can load it on TS, all the better. That inhaler can't cost more than a few cents. I sure hope Mike negotiates a great deal with UTHR to sell the product. They have the sales reps and know the doctors and industry. I would hate to have the same sales success as we have had with afrezza. To think no lessons have been learned by MC during his tenure so far would be naive. Then again wouldn’t surprise me coming from you. I sure hope he has learned a few lessons from Martine on how to sell and can apply them in 2023 with afrezza and V-Go which went in the sale reps "bags" last week. I hope he has also learned that breaking into a new industry when you are an outsider can be a rough road especially when you don't have an industry expert by your side who can open doors. |
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Post by akemp3000 on Jan 23, 2023 21:15:24 GMT -5
From the Las Angeles Times and more:
Michael Castagna became CEO of MannKind and joined its board of directors in 2017, bringing 25+ years’ experience in healthcare, pharmaceuticals and biotechnology to the company’s product and medical device development strategy. Previously, Michael served as a Vice President at Amgen, guiding the Lifecycle Management and Global Commercial Biosimilar business areas. Before Amgen, he spent a combined 10 years at Bristol-Myers Squibb, focusing on medical, marketing and sales (1997-2005), and returning to the company from 2010-2012 to direct the Immunoscience division. Other experience includes serving as Vice President at Sandoz, as well as a Director at both Merck, Serono and Pharmasset. Dr. Michael Castagna earned his doctorate in Pharmacy and Masters degree from The Wharton School of Business.
It does not look good for anyone here to suggest or imply they know more about this industry than Michael Castagna unless an equal or better bio is provided. Criticism of specific trials, errors or actions of a CEO is perfectly fine but to suggest...oh, never mind. Back to more important topics.
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Post by cedafuntennis on Jan 23, 2023 21:21:18 GMT -5
Based on the paper I think the study was done using "beagle dogs". I am assuming they could not teach the beagle how to hold the TI inhaler with their paw. Then again maybe beagles "don't inhale". It does not mention that in the paper. journals.asm.org/doi/10.1128/aac.01144-22They should’ve enlisted Snoopy for the trial, he could learn how to use the inhaler and I strongly suspect he would also inhale. 😎 And maybe Bill C who will probably inhale this time or admit he did. Sorry, couldn't resist. |
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Post by longliner on Jan 23, 2023 21:36:22 GMT -5
They should’ve enlisted Snoopy for the trial, he could learn how to use the inhaler and I strongly suspect he would also inhale. 😎 And maybe Bill C who will probably inhale this time or admit he did. Sorry, couldn't resist. I think you hit on a winner!! |
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Post by dh4mizzou on Jan 24, 2023 13:37:14 GMT -5
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Post by casualinvestor on Jan 24, 2023 14:31:15 GMT -5
Dosage looks to be once a day, making a nebulizer less of an issue than something like Tyvaso which is 4x per day. IMO it's a good idea to stay the course until there's revenue from it. Then use that money to work DPI through the hoops.
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