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Post by georgethenight2 on Jan 26, 2020 11:02:20 GMT -5
Just some very random thoughts of mine here in Japan on a Sunday night.
Curious to know others opinion on the idea of Afrezza coming off patient. I know we still have more than a decade of protections remaining, but the idea that Afrezza is not possible with out the the inhaler. And does its patient protection work in much the same way as a drug? If the patient protections are different would the company that wants to create a generic version also have to pay a royalty to MNKD to use the inhaler?
Also, Peppy has stated, "It is all an insurance game from here." What if a large investor were to simultaneously own MNKD stock and for example United Healthcare. The investor sees MNKD as Peppy does, the biggest reason for the stagnation in share price is the lack of coverage. Having this understand/plan the large investor approaches the United Healthcare BODs and argues a case for Tier 1 or Tier 2 coverage. The BOD and those who run the company are reluctant to do this, but the large investor represents a large ownership in the company and his/her sway can not be ignored. Thus the large investor sees increased coverage, thus increase in rx and sales, and in turn a very excellent return on his MNKD shares which he/she previously bought for under a buck 80. Is this even possible?
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Post by sayhey24 on Jan 26, 2020 11:21:41 GMT -5
The manufacturing process for afrezza is pretty complex. I am not sure anyone would take on trying to build their own until afrezza is doing a few $B per year.
The RLS approach was to give MNKD about 22% royalties.
The main reason for lack of insurance is afrezza up until now has been seen as a niche drug. As Dr. Kendall makes additional progress in SOC updates and broad community acceptance and demonstrates how afrezza playing the long game actually is a huge money saver, insurance will follow. Just as a T1 "Rescue" tool a cost saving analysis should be possible.
Lets see what Dr. Kendall says in February and what progress he has made.
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Post by mnkdfann on Jan 26, 2020 11:55:50 GMT -5
Just some very random thoughts of mine here in Japan on a Sunday night. Curious to know others opinion on the idea of Afrezza coming off patient. I know we still have more than a decade of protections remaining, but the idea that Afrezza is not possible with out the the inhaler. Not sure what you were trying to say there, but some Afrezza users on the facebook page recently wrote about how they often breathed from a slightly opened cartridge directly, without using the inhaler. No idea if that is a good idea, but their claim was that it still worked. |
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Post by cretin11 on Jan 26, 2020 13:12:48 GMT -5
Just some very random thoughts of mine here in Japan on a Sunday night. Peppy has stated, "It is all an insurance game from here." What if a large investor were to simultaneously own MNKD stock and for example United Healthcare. The investor sees MNKD as Peppy does, the biggest reason for the stagnation in share price is the lack of coverage. Having this understand/plan the large investor approaches the United Healthcare BODs and argues a case for Tier 1 or Tier 2 coverage. The BOD and those who run the company are reluctant to do this, but the large investor represents a large ownership in the company and his/her sway can not be ignored. Thus the large investor sees increased coverage, thus increase in rx and sales, and in turn a very excellent return on his MNKD shares which he/she previously bought for under a buck 80. Is this even possible? I do not think that is possible. |
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Post by mango on Jan 26, 2020 13:21:52 GMT -5
The manufacturing process for afrezza is pretty complex. I am not sure anyone would take on trying to build their own until afrezza is doing a few $B per year. The RLS approach was to give MNKD about 22% royalties. The main reason for lack of insurance is afrezza up until now has been seen as a niche drug. As Dr. Kendall makes additional progress in SOC updates and broad community acceptance and demonstrates how afrezza playing the long game actually is a huge money saver, insurance will follow. Just as a T1 "Rescue" tool a cost saving analysis should be possible. Lets see what Dr. Kendall says in February and what progress he has made. The process is extremely complex. Sanofi couldn’t even pull it off which is why it was never a part of the agreement to let Sanofi manufacture Afrezza. Sanofi simply does not possess the equipment nor had the expertise and know how. Training Sanofi would have been too risky, it is that complex. UT on the other is capable of manufacturing TreT. I’d even argue they are capable of manufacturing Afrezza. |
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Post by falconquest on Jan 26, 2020 13:27:41 GMT -5
Given the complexity of development and manufacture and the relatively low acceptance by the marketplace, why would anyone bother at this point?
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Post by longliner on Jan 26, 2020 13:33:55 GMT -5
Just some very random thoughts of mine here in Japan on a Sunday night. Curious to know others opinion on the idea of Afrezza coming off patient. I know we still have more than a decade of protections remaining, but the idea that Afrezza is not possible with out the the inhaler. Not sure what you were trying to say there, but some Afrezza users on the facebook page recently wrote about how they often breathed from a slightly opened cartridge directly, without using the inhaler. No idea if that is a good idea, but their claim was that it still worked. Another great big THANKS to our malleable FDA for extending the years to market due to differences in the inhaler. Rot in hell Shkreli. |
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Post by matt on Jan 26, 2020 14:01:00 GMT -5
The essence of a generic drug is that it is so well-accepted in the marketplace that no sales or marketing is required, and there is lots of profit that can be captured by an imitator. That is not a very good description of Afrezza.
There are a lot of patents that remain valid, but the core patents that Al Mann bought back in the 1990's are long expired at this point. If a determined competitor wanted to introduce a generic Afrezza, they can likely find a way around any manufacturing patents as there are plenty of clever engineers in the world. The essential patents that block most generics are for "composition of matter" for the molecule, and for that there is little to keep a competitor at bay.
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Post by figglebird on Jan 26, 2020 14:22:13 GMT -5
The manufacturing process for afrezza is pretty complex. I am not sure anyone would take on trying to build their own until afrezza is doing a few $B per year. The RLS approach was to give MNKD about 22% royalties. The main reason for lack of insurance is afrezza up until now has been seen as a niche drug. As Dr. Kendall makes additional progress in SOC updates and broad community acceptance and demonstrates how afrezza playing the long game actually is a huge money saver, insurance will follow. Just as a T1 "Rescue" tool a cost saving analysis should be possible. Lets see what Dr. Kendall says in February and what progress he has made. The process is extremely complex. Sanofi couldn’t even pull it off which is why it was never a part of the agreement to let Sanofi manufacture Afrezza. Sanofi simply does not possess the equipment nor had the expertise and know how. Training Sanofi would have been too risky, it is that complex. UT on the other is capable of manufacturing TreT. I’d even argue they are capable of manufacturing Afrezza. |
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Post by figglebird on Jan 26, 2020 14:29:39 GMT -5
To quick remarks and/or corrections regarding sanofi there was a manufacturing option as part of the contract that would have required in the event sanofi at their exclusive choice gone through with it a transfer of technology which was well described in the contract of course they did not go through with it but this does speak to the complexity of what management also re emphasized at the last annual shareholders meeting not easily reciprocated so to the 2nd point made about engineers finding a way around these patents if the view is that they can simply rip off tap in to fear as their own I disagree - mnkd has approx a 1000 legal barriers that ensure exclusive use of fdkp as their own for scores of apiscand indications.
Also the tech itself is one of a kind - now bringing another dpi insulin is certainly within the realm of possibility BUT unless it were fdkp, it ain't approved- thus generation of meaningful revenue as traditionally understood is far from limiting the scope of simply taking first position- and the emerging moat that comes w that
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Post by ktim on Jan 26, 2020 18:04:30 GMT -5
Just some very random thoughts of mine here in Japan on a Sunday night. Curious to know others opinion on the idea of Afrezza coming off patient. I know we still have more than a decade of protections remaining, but the idea that Afrezza is not possible with out the the inhaler. And does its patient protection work in much the same way as a drug? If the patient protections are different would the company that wants to create a generic version also have to pay a royalty to MNKD to use the inhaler? Also, Peppy has stated, "It is all an insurance game from here." What if a large investor were to simultaneously own MNKD stock and for example United Healthcare. The investor sees MNKD as Peppy does, the biggest reason for the stagnation in share price is the lack of coverage. Having this understand/plan the large investor approaches the United Healthcare BODs and argues a case for Tier 1 or Tier 2 coverage. The BOD and those who run the company are reluctant to do this, but the large investor represents a large ownership in the company and his/her sway can not be ignored. Thus the large investor sees increased coverage, thus increase in rx and sales, and in turn a very excellent return on his MNKD shares which he/she previously bought for under a buck 80. Is this even possible? Your second question seems to basically be whether in the case that data alone is insufficient to convince insurers, whether pressure from an activist investor would sway them? Obviously if this person were to become a 51% owner then they have control. Even short of that, one would assume they might have some influence. Though the insurance company could run into shareholder liability issues if they were doing things not in their own shareholders interests but to enrich one particular shareholder based on other holdings of that person. Does this investor disclose his MNKD position when he is lobbying UNH? Bottom line, I'd check with attorney before spending $13 Billion to acquire a 5% stake in UNH. Or you might want to simply consider investing one one hundredth that amount in MNKD to allow them to do the trials that would actually convince UNH. |
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Post by rockstarrick on Jan 27, 2020 15:38:23 GMT -5
I think the actual product, (insulin human), would be the easy part, an FDA approved inhaler, and the approved process to convert the API would be the deciding factor weather to try an Inhaled generic. I brought up the concept of Mannkind utilizing “Inhaled Generics” a long time ago, I believe we were discussing Amphastar and their new production facility in China. It would be great to be the Company that covered Inhaled Generics, not sure how it would work for anybody else, to use our device and technology. mnkd.proboards.com/thread/2299/amphastar-inhaled-generics |
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