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Post by hellodolly on Jan 10, 2024 7:53:58 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. 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. We might not face yet another Citizen's Petition with the nebulized version? DPI version has a better track record of attracting the miscreants. |
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Post by letitride on Jan 10, 2024 8:06:51 GMT -5
I would follow up with I believe a DPI version would require another line in Danbury that is probably already maxed with Tyvasso DPI and Afrezza at the moment.
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Post by sayhey24 on Jan 10, 2024 9:40:06 GMT -5
I would follow up with I believe a DPI version would require another line in Danbury that is probably already maxed with Tyvasso DPI and Afrezza at the moment. That I would view as a happiness problem. I sure hope that is the reason. For the trials in the past they have used the little lab filler. |
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Post by prcgorman2 on Jan 10, 2024 11:03:51 GMT -5
Mike has said for some time the path was get approval for nebulized Clofazimine first, then look at Clofazimine on TechnoSphere. This was based on discussions with the FDA. I have to believe it is the "fast track". You might think the FDA response to the citizen's petition for disapproval of Tyvaso DPI would have laid to rest any inhibition for taking TS-enhanced formulations forward for FDA approval, but for whatever reasons, the path is nebulized, then TS-enhanced. I don't see that as a significant problem. From a business perspective, "a dollar now is worth more than a dollar later".
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limo
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Post by limo on Jan 10, 2024 11:19:35 GMT -5
interesting point around capacity. How much room do we have left if for eg Afrezza scaled up? would we need to invest and build another production facility? As now tyasvo is taking up all the room at the inn.
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Post by prcgorman2 on Jan 10, 2024 11:34:14 GMT -5
The point is a good one. I assume MNKD's capacity to produce Afrezza will for some time to come far exceed demand. But if the LONGed for "hockey stick" in prescriptions happens in the next 2 years, capacity could be a problem.
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limo
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Post by limo on Jan 10, 2024 11:45:02 GMT -5
The point is a good one. I assume MNKD's capacity to produce Afrezza will for some time to come far exceed demand. But if the LONGed for "hockey stick" in prescriptions happens in the next 2 years, capacity could be a problem. so in that case i guess we want / need partners to fund the expansions otherwise we'll be need to raise big $. I wonder if that is the reason we trade so cheaply? UTHR has had to spend ~$600m building out a facility, MNKD would have to do the same for Nintedanib and clofazimine if they moved over to dpi. someone please correct me if im totally wrong and forgive me! would makes sense why the mkt is so underwhelmed by the "go it alone" strategy |
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Post by prcgorman2 on Jan 10, 2024 11:56:36 GMT -5
I won't try to correct you. The market that's been described for clofazimine is 100,000 candidates in Japan, and another 100,000 in the US. That's not a large population. If clofazmine and nintedanib (and Afrezza and expanded indication for Tyvaso DPI) materialize and begin to show the promise of $$ described by the CEO, getting money for expansion will likely not be a problem. A bigger challenge will be time. A couple of the things I've liked about the UTHR build of another Afrezza-capable factory is the potential for disaster and business-recovery as well as (temporary?) expansion of production capacity. Easy to say. The devil is in the details. Capacity is a good problem to have, but my opinion is it is not likely to be what is holding the share price in check.
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limo
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Post by limo on Jan 10, 2024 13:42:17 GMT -5
Given we can only produce enough tyvaso for 25k patients per year 200k is a big population! But I hear you , if it looks like the mkt is there then even with a dilutive cash raise the shares would go up.
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Post by sayhey24 on Jan 10, 2024 14:07:54 GMT -5
Mike has said for some time the path was get approval for nebulized Clofazimine first, then look at Clofazimine on TechnoSphere. This was based on discussions with the FDA. I have to believe it is the "fast track". You might think the FDA response to the citizen's petition for disapproval of Tyvaso DPI would have laid to rest any inhibition for taking TS-enhanced formulations forward for FDA approval, but for whatever reasons, the path is nebulized, then TS-enhanced. I don't see that as a significant problem. From a business perspective, "a dollar now is worth more than a dollar later". At this point in time the citizen's petition is in the rear view mirror. After 8 years of TS in clinical use with afrezza and another year with Tyvaso DPI lets hope DPI safety concerns are behind us. I have listened to Mike and his reason for going nebulizer first. I was left with the impression it was all about speed to market. But then the fire happened and things got delayed. I would have expected Mike to announce a shift of plans and them dropping the nebulizer for DPI. Nope. Lets see what he says tomorrow. If he does not have a clear roadmap getting to DPI then I have the feeling they are having issues making it work as a DPI. Maybe this is the reason UTHR has not partnered yet. After hearing UTHR praising DPI the other day, going nebulizer first to get to market 6 months earlier makes no sense. |
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Post by hellodolly on Jan 12, 2024 13:22:50 GMT -5
Listening to Mike at the latest JPM Conference yesterday, at around the 15:20 stamp on the replay, he mentioned the differences between the saline, oral and nebulizer and the nebulized MNKD 101 version presents a "99% reduction in the bacteria, the bacteria did not recover". So, from that stand point, it makes sense as well as the speed to market. Slide sixteen (16) actually shows a 99.99% reduction in MNKD 101 at 2.45 Log 10, versus the higher with saline (6.4 Log 10) or oral (5.94 Log 10) clofazimine.
By the way, slide 17 shows that they have identified an initial powder formulation of the drug, too.
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Post by castlerockchris on Jan 12, 2024 19:02:20 GMT -5
Add to that the fact that the dosing is not nearly as frequent, nor burdensome as with other applications of DPI, and I am not sure I see a need to move to DPI any time soon. Just like UTHR did with T-DPI, stretch out the nebulizer version, wait until you have to protect your franchise and IP, then move to DPI. Orphan drug status means the FDA may pick up part of the expenses of the trail and MNKD may receive up to 7 years of exclusivity upon approval. Again, no need to move to DPI for at least that time period, if it is granted.
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Post by radgray68 on Jan 12, 2024 20:39:31 GMT -5
When we acquired clofazimine, Mike said the conversion to DPI would be a "product life cycle" decision they'll make at a later date. I took that to mean exactly what castlerock said above about copying UTHR's playbook.
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limo
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Post by limo on Jan 15, 2024 3:57:38 GMT -5
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Post by agedhippie on Jan 15, 2024 11:23:48 GMT -5
Thanks for the links. Having read the presentation and the transcript it looks really interesting. There seems to be a lot of overlap with MNKD, but I think they are at least two years behind. If TPIP works it has a lot of potential and it's interesting that they are going for PH-ILD first and PAH second. As I read it TPIP is essentially a treprostinil analog and not pure treprostinil delivered via a DPI. Their existing drug, ARIKAYCE, is in trials for MAC/ NTM and is nebulized. The side effects look pretty awful, and it's licensed as a last resort drug although there is a trial running to change that label. |
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