Preparation, characterization, and pharmacodynamics of insul

[brotherm1]

Yun Xia, Yipeng Su, [...], and Yan Shen
Preparation, characterization, and pharmacodynamics of insulin-loaded fumaryl diketopiperazine microparticle dry powder inhalation


www.ncbi.nlm.nih.gov/pmc/articles/PMC6609328/#!po=0.581395

[ryster505]

So is this your typical Chinese copycat syndrome, or is MNKD associated with this? Patents? Lost here.

[mnholdem]

This appears to extensive testing of MannKind’s Technosphere by the Chinese rather than production or patent violation. The report may bode well for introducing Afrezza to the Chinese market.

[mannmade]

Well as I recall Amph gave up their right of first refusal so perhaps there was a reason..,

[akemp3000]

Good to hear the Chinese saying, "...remarkably potential on diabetes treatment by pulmonary delivery route."

[ktim]

Although the inhaled insulin powder Afrezza®, which has been marketed, can significantly reduce the incidence of hypoglycemia and relieve the pain of patients, the sales volume and the market feedback of Afrezza® is unsatisfactory as well. The reason for the poor sales of Afrezza® may be that people are still skeptical about the safety of insulin DPIs, and the price of the inhaler and its associated inhalation device is higher than that of insulin injection (Fantasia, 2015). Compared with Afrezza®, this paper aims to optimize the preparation process of INS@FDKP-MPs by adopting a simpler and more convenient synthesis method to reduce the production cost, and by evaluating the properties of INS@FDKP-MPs, it is intended to construct an inhalable insulin preparation that is qualified in particle size, drug loading, hypoglycemic effect, and safety.

So this seems to be going beyond merely testing of Afrezza.  Seems to contemplate an improved, possibly competing, product.

Would MNKD's existing patents protect against this and for how long?  Would they seek to license MNKD's existing patents?  Will they succeed in reducing production cost?  Would this somehow fall within the reduced testing requirements of "biosimilar" or would it require full blown set of trials?

Lots of questions.  Wonder if MNKD management will feel compelled to address it.

[paul]

Also discussed back in July: mnkd.proboards.com/thread/11351/abstract-on-technosphere-insulin

[mannmade]

Sept 4, 2019 12:45:18 GMT -5 ktim said:

Although the inhaled insulin powder Afrezza®, which has been marketed, can significantly reduce the incidence of hypoglycemia and relieve the pain of patients, the sales volume and the market feedback of Afrezza® is unsatisfactory as well. The reason for the poor sales of Afrezza® may be that people are still skeptical about the safety of insulin DPIs, and the price of the inhaler and its associated inhalation device is higher than that of insulin injection (Fantasia, 2015). Compared with Afrezza®, this paper aims to optimize the preparation process of INS@FDKP-MPs by adopting a simpler and more convenient synthesis method to reduce the production cost, and by evaluating the properties of INS@FDKP-MPs, it is intended to construct an inhalable insulin preparation that is qualified in particle size, drug loading, hypoglycemic effect, and safety.

So this seems to be going beyond merely testing of Afrezza.  Seems to contemplate an improved, possibly competing, product.

Would MNKD's existing patents protect against this and for how long?  Would they seek to license MNKD's existing patents?  Will they succeed in reducing production cost?  Would this somehow fall within the reduced testing requirements of "biosimilar" or would it require full blown set of trials?

Lots of questions.  Wonder if MNKD management will feel compelled to address it.

Seriously?   If only Mnkd were in the Security Business.  They are better at keeping secrets and preventing leaks than any agency in the US Govt. 

[mnholdem]

MannKind did release an improved particle, after FDA approval, which is

1. Cheaper to manufacture;
2. Allows more API to bond with the particle, which could result in
3. Larger doses (18-24 units) using the existing cartridge. 

The Chinese appear to have evaluated both production methods. 

[mango]

Sept 4, 2019 13:26:52 GMT -5 mannmade said:

Sept 4, 2019 12:45:18 GMT -5 ktim said:

So this seems to be going beyond merely testing of Afrezza.  Seems to contemplate an improved, possibly competing, product.

Would MNKD's existing patents protect against this and for how long?  Would they seek to license MNKD's existing patents?  Will they succeed in reducing production cost?  Would this somehow fall within the reduced testing requirements of "biosimilar" or would it require full blown set of trials?

Lots of questions.  Wonder if MNKD management will feel compelled to address it.

Seriously?   If only Mnkd were in the Security Business.  They are better at keeping secrets and preventing leaks than any agency in the US Govt. 

so true 😂

[goyocafe]

Sept 4, 2019 16:11:39 GMT -5 mnholdem said:

MannKind did release an improved particle, after FDA approval, which is

1. Cheaper to manufacture;
2. Allows more API to bond with the particle, which could result in
3. Larger doses (18-24 units) using the existing cartridge. 

The Chinese appear to have evaluated both production methods. 

We can hope the patent moat holds, but we have to consider who we're dealing with here. 

[ktim]

Sept 4, 2019 16:11:39 GMT -5 mnholdem said:

MannKind did release an improved particle, after FDA approval, which is

1. Cheaper to manufacture;
2. Allows more API to bond with the particle, which could result in
3. Larger doses (18-24 units) using the existing cartridge. 

The Chinese appear to have evaluated both production methods. 

Does this new cheaper process have to go through FDA approval?  How much cheaper?  Somehow that slipped by me.

[mnholdem]

patents.justia.com/patent/9446001

[goyocafe]

Sept 5, 2019 7:54:31 GMT -5 mnholdem said:

patents.justia.com/patent/9446001

Didn’t the plant expansion they just completed have something to do with high potency? I wonder if the process is using the process associated with this patent? And better, if this process gives cover for what the Chinese paper discussed.

[ktim]

Sept 5, 2019 9:44:27 GMT -5 goyocafe said:

Sept 5, 2019 7:54:31 GMT -5 mnholdem said:

patents.justia.com/patent/9446001

Didn’t the plant expansion they just completed have something to do with high potency? I wonder if the process is using the process associated with this patent? And better, if this process gives cover for what the Chinese paper discussed.

This patent seems fairly old.  It may relate to the process used all along for Afrezza commercial production.  Is the new "high potency" capability related to new chemistry process or simply procedures related to safe handling of "high potency" compounds?