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Post by uvula on Jan 28, 2024 9:09:14 GMT -5
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Post by sayhey24 on Jan 28, 2024 9:32:23 GMT -5
Of course they can but they won't. BP wants to keep MNKD marginalized.
Not only that but if these drugs are coming off patent wouldn't it make more sense to just do it ourselves? Lets take Victoza as an example. The down side is we waste $10M doing a pilot. Upside is we have a blockbuster for cheap in a $100B market.
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Post by agedhippie on Jan 28, 2024 10:40:12 GMT -5
The problem is obviousness. The patent courts really don't like companies attempting to extend dying patents by using obvious modifications. In the LQDA case this was summed up by a question Judge Lourie asked why the use of DPI wasn't within the normal skills of the art since DPI delivery is not exactly revolutionary, in which case the '793 was just a rehash of the '212 patent. His whole focus was on obviousness. You could probably get a patent for a specific API on TS, but you wouldn't be protected from a different delivery mechanism using the same API even if it was also inhaled. |
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Post by prcgorman2 on Jan 29, 2024 10:04:52 GMT -5
The problem is obviousness. The patent courts really don't like companies attempting to extend dying patents by using obvious modifications. In the LQDA case this was summed up by a question Judge Lourie asked why the use of DPI wasn't within the normal skills of the art since DPI delivery is not exactly revolutionary, in which case the '793 was just a rehash of the '212 patent. His whole focus was on obviousness. You could probably get a patent for a specific API on TS, but you wouldn't be protected from a different delivery mechanism using the same API even if it was also inhaled. The results of the approval trial showed a clear experiential improvement in Treprostinil on TechnoSphere versus the Tyvaso nebulizing flashlight. I don't think that is patentable, but where that same experience and compliance improvement might apply to other products, it might encourage uptake of TS.
And while it may be obvious TS can carry molecules (that is what it was designed for after all), I would think the formulation ought to be patentable because of its uniqueness. There are measurable differences in lung penetration, amount of drug needed, patient experience, safety profile, et cetera.
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Post by hopingandwilling on Jan 29, 2024 14:23:16 GMT -5
<<<<TS can carry molecules (that is what it was designed for after all)>>>>
You can carry water in a pail from a water well in your backyard for use in your house, but today, most homeowners like their water being delivered through a pipe from the water purification plant. My point is there are about 15 dry powder drugs that have been approved by the FDA. Other than Afrezza, these drugs are generating millions for the drug company that owns them. Keep in mind that even MannKind has confirmed that the delivery of a drug via a nebulizer must be better than Technosphere (TI). Why would other drug companies want to adopt the TI system when they can use the Ellipta inhaler, which comes preloaded with multiple doses of the respective drug?
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Post by prcgorman2 on Jan 29, 2024 14:26:45 GMT -5
Afrezza is also generating millions for the drug company that owns it.
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Post by slapshot on Jan 29, 2024 14:37:40 GMT -5
<<<<TS can carry molecules (that is what it was designed for after all)>>>> You can carry water in a pail from a water well in your backyard for use in your house, but today, most homeowners like their water being delivered through a pipe from the water purification plant. My point is there are about 15 dry powder drugs that have been approved by the FDA. Other than Afrezza, these drugs are generating millions for the drug company that owns them. Keep in mind that even MannKind has confirmed that the delivery of a drug via a nebulizer must be better than Technosphere (TI). Why would other drug companies want to adopt the TI system when they can use the Ellipta inhaler, which comes preloaded with multiple doses of the respective drug? Why do you say this "Keep in mind that even MannKind has confirmed that the delivery of a drug via a nebulizer must be better than Technosphere (TI)"? |
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Post by hopingandwilling on Jan 29, 2024 15:04:43 GMT -5
Slap,
I state that MannKind is doing this because “if” they ever get their promised clofazimine drug into FDA-approved clinical trials—they will be using a nebulizer to deliver the drug. This is no big secret—you can see it in MannKind SEC filing, etc. You should take time to read such documents if you are investing in their company because of TI—just a friendly suggestion!
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Post by stella on Jan 29, 2024 15:28:17 GMT -5
If there are 15 superior DPI platforms out there, then why did United Therapeutics choose Technosphere for their Tyvaso DPI product? Clearly they had to have evaluated all of the DPI platforms currently in the market. Tyvaso DPI current revenue run-rate is $820 million. That's just for PAH. MNKD is using a jet nebulizer in its clofazimine trial in order to condense and accelerate the clinical trials. They will explore a DPI version if and when the market requires one. Perhaps you should take time to read such documents and improve your due diligence.
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Post by slapshot on Jan 29, 2024 16:27:18 GMT -5
Slap, I state that MannKind is doing this because “if” they ever get their promised clofazimine drug into FDA-approved clinical trials—they will be using a nebulizer to deliver the drug. This is no big secret—you can see it in MannKind SEC filing, etc. You should take time to read such documents if you are investing in their company because of TI—just a friendly suggestion! Thank you for responding, i figured that was your basis for your thesis, however i don't believe the facts back up your statement. i do believe you have quite an imagination, perhaps you can brainstorm and come up with other possible reasons why Mannkind (or any other company) may choose this path that don't actually confirm "the delivery of a drug via a nebulizer must be better than Technosphere ".
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Post by uvula on Jan 29, 2024 16:44:03 GMT -5
Slap, I state that MannKind is doing this because “if” they ever get their promised clofazimine drug into FDA-approved clinical trials—they will be using a nebulizer to deliver the drug. This is no big secret—you can see it in MannKind SEC filing, etc. You should take time to read such documents if you are investing in their company because of TI—just a friendly suggestion! Thank you for responding, i figured that was your basis for your thesis, however i don't believe the facts back up your statement. i do believe you have quite an imagination, perhaps you can brainstorm and come up with other possible reasons why Mannkind (or any other company) may choose this path that don't actually confirm "the delivery of a drug via a nebulizer must be better than Technosphere ".
Slapshot, you are more polite than I would have been in this situation. |
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Post by anderson on Jan 29, 2024 17:56:40 GMT -5
Slap, I state that MannKind is doing this because “if” they ever get their promised clofazimine drug into FDA-approved clinical trials—they will be using a nebulizer to deliver the drug. This is no big secret—you can see it in MannKind SEC filing, etc. You should take time to read such documents if you are investing in their company because of TI—just a friendly suggestion! Clofazimine was already doing trials as nebulized form when MNKD bought the company. TI clofazimine is on the agenda but it would have pushed back approval time a year+ since they need to formulate and figure out dosing. It has been discussed at length. So your claim that nebulizer is better holds no weight. This was purely a time line for approval discission. |
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Post by sayhey24 on Jan 29, 2024 20:58:27 GMT -5
Slap, I state that MannKind is doing this because “if” they ever get their promised clofazimine drug into FDA-approved clinical trials—they will be using a nebulizer to deliver the drug. This is no big secret—you can see it in MannKind SEC filing, etc. You should take time to read such documents if you are investing in their company because of TI—just a friendly suggestion! Clofazimine was already doing trials as nebulized form when MNKD bought the company. TI clofazimine is on the agenda but it would have pushed back approval time a year+ since they need to formulate and figure out dosing. It has been discussed at length. So your claim that nebulizer is better holds no weight. This was purely a time line for approval discission. At one of the recent conferences Mike seemed very happy that MNKD was finally able to get the TI dosing for clofazimine done. It seems like it was a lot of work and there were concerns they were having issues. Now that they have figured it out I think it would be worth the delay. Since its already been delayed 6 months due to the fire, whats another 6 months to retool. Redoing trials later for the DPI and relabeling doesn't make much sense to me. |
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Post by Clement on Jan 30, 2024 8:46:45 GMT -5
At one of the recent conferences Mike seemed very happy that MNKD was finally able to get the TI dosing for clofazimine done. Please provide a specific link. I would like to read more. |
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Post by hellodolly on Jan 30, 2024 9:54:20 GMT -5
At one of the recent conferences Mike seemed very happy that MNKD was finally able to get the TI dosing for clofazimine done. Please provide a specific link. I would like to read more. Quotations are MC: Listening to Mike at the latest JPM Conference, 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. He stated this, "We'll look at moving the dry powder formulation forward because if we want to compete with early naïve patients, it will be good to have that moving forward."
Why MNKD is moving forward first with the nebulized version might be related to this as well as some other points taken from his presentation on NTM: The name of the trial ICoN-1, the decision to move ahead with the nebulizer version at this time is based on the efficacy of MNKD-101 which so far in human trials has shown to be effective as it presents "low systemic exposure, localized concentrations in the lungs and less side effects." Mike mentioned that the current oral dose of clofazimine has horrible side effects that many people drop off as a result. The current SoC requires a patient to adhere to "regimens that take patients anywhere from 18 months to five years" and that even with people who have a life expectancy of five years once diagnosed with NTM, they would rather die and not take the drug because the side effects are terrible and "exacerbate their poor quality of life." So, to that end..it makes sense to go with the nebulizer version as the other versions are no doubt very efficacious, but intolerable and "patients just give up." Finally, the nebulizer version of MNKD-101 is able to "cut the dose by 80%...that is delivered directly to the lungs...to kill the bug in the lung with our suspension." A little more than you asked for but the context around his comment is just as important. |
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