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Post by mango on Mar 21, 2017 19:30:17 GMT -5
Use of ultrarapid acting insulinType: Grant Filed: January 25, 2012 Date of Patent: March 21, 2017 Assignee: MannKind Corporation Inventors: Anders Hasager Boss, Richard Petrucci, Campbell Howard, Alfred Mann patents.justia.com/patent/9597374
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Post by dreamboatcruise on Mar 21, 2017 20:19:57 GMT -5
Seems that other companies are trying to develop more rapid insulins. Will this really prevent others from doing so?
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Post by seanismorris on Mar 21, 2017 20:21:32 GMT -5
I've started reading the "Patent" but it isn't clear what the patent is for...
Is there a patent lawyer in the house?
They use "Ultrarapid" acting several times... Is the intention to establish what Ulta means before getting the Label for Afrezza changed?
The patent reads more like a superiority trial, attempting to demonstrate that Ultarapid acting insulin should be part of the "standard" treatment for diabetes (in many situations).
Is MannKind trying to use "patent pending" as a way to recommend the proper way to use Afrezza, rather than what's on the Label?
Is MannKind trying to (in some way) bypass dealing with the FDA?
Anyone able to contact Matt for clarification?
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Post by seanismorris on Mar 21, 2017 20:26:47 GMT -5
Seems that other companies are trying to develop more rapid insulins. Will this really prevent others from doing so? Good question. I don't know if that's possible. If I was the patent office I wouldn't approve it with that goal... That's like trying to patent "delayed release" basal insulin. But, with the patent system like it is, who knows.
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Post by dreamboatcruise on Mar 21, 2017 20:35:21 GMT -5
I've started reading the "Patent" but it isn't clear what the patent is for... Is there a patent lawyer in the house? They use "Ultrarapid" acting several times... Is the intention to establish what Ulta means before getting the Label for Afrezza changed? The patent reads more like a superiority trial, attempting to demonstrate that Ultarapid acting insulin should be part of the "standard" treatment for diabetes (in many situations). Is MannKind trying to use "patent pending" as a way to recommend the proper way to use Afrezza, rather than what's on the Label? Is MannKind trying to (in some way) bypass dealing with the FDA? Anyone able to contact Matt for clarification? It doesn't seem to be written in a way that would make it necessarily limited to TI ultrarapid. It seems to cover how one would use and titrate an ultrarapid. No I don't think this helps with what can be communicated to patients or how the FDA would view Afrezza for any purpose. Patents have nothing to do with that regulatory process. It is either trying to prevent another company from doing something, or it is... a waste of money to puff up the number of patents their staff have.
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Post by seanismorris on Mar 21, 2017 20:51:47 GMT -5
I've started reading the "Patent" but it isn't clear what the patent is for... Is there a patent lawyer in the house? They use "Ultrarapid" acting several times... Is the intention to establish what Ulta means before getting the Label for Afrezza changed? The patent reads more like a superiority trial, attempting to demonstrate that Ultarapid acting insulin should be part of the "standard" treatment for diabetes (in many situations). Is MannKind trying to use "patent pending" as a way to recommend the proper way to use Afrezza, rather than what's on the Label? Is MannKind trying to (in some way) bypass dealing with the FDA? Anyone able to contact Matt for clarification? It doesn't seem to be written in a way that would make it necessarily limited to TI ultrarapid. It seems to cover how one would use and titrate an ultrarapid. No I don't think this helps with what can be communicated to patients or how the FDA would view Afrezza for any purpose. Patents have nothing to do with that regulatory process. It is either trying to prevent another company from doing something, or it is... a waste of money to puff up the number of patents their staff have. I agree about it not necessarily limited to TI. That's why I was wondering if it was to first define what Ultra means, so Afrezza could get the Ultra Label from the FDA. The patent is definitely a strange one... it feels like we are only hearing 1 side of a 2 or 3 way conversation.
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Post by sayhey24 on Mar 21, 2017 20:54:44 GMT -5
Finally - the new dosing instructions for the new label from the clamp studies. I would have liked it better if they went stronger after metformin and said just throw it in the trash as it will just mess up proper liver function.
Now, the next step are the associated computer models which take all this info on dosing and marry it with real time data from the CGMs and tell the PWD how to dose so they don't need to read all that "label" stuff and figure it out on their own. What did Josh Riff say at the Digital Diabetes Congress the other week about the future - easy ways to tell PWD how to dose and a new way to take insulin.
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Post by dreamboatcruise on Mar 21, 2017 22:37:55 GMT -5
Finally - the new dosing instructions for the new label from the clamp studies. I would have liked it better if they went stronger after metformin and said just throw it in the trash as it will just mess up proper liver function. Now, the next step are the associated computer models which take all this info on dosing and marry it with real time data from the CGMs and tell the PWD how to dose so they don't need to read all that "label" stuff and figure it out on their own. What did Josh Riff say at the Digital Diabetes Congress the other week about the future - easy ways to tell PWD how to dose and a new way to take insulin. This pretty much describes every possibility of usage of Afrezza it seems... with and without prandial, with and without orals. It's a patent to prevent others from doing the same types of treatment (regardless of whether it really will do that). If you'll notice this was filed way back in 2012. I wouldn't read too much from this about what they may or may not be submitting to FDA for label change. Mannkind would never apply for a label saying MNKD shouldn't be used with Metformin... that would truly be counterproductive for our sales efforts for the T2 market.
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Post by porkini on Mar 21, 2017 23:22:43 GMT -5
I've started reading the "Patent" but it isn't clear what the patent is for... Is there a patent lawyer in the house?They use "Ultrarapid" acting several times... Is the intention to establish what Ulta means before getting the Label for Afrezza changed?The patent reads more like a superiority trial, attempting to demonstrate that Ultarapid acting insulin should be part of the "standard" treatment for diabetes (in many situations). Is MannKind trying to use "patent pending" as a way to recommend the proper way to use Afrezza, rather than what's on the Label?Is MannKind trying to (in some way) bypass dealing with the FDA?Anyone able to contact Matt for clarification? Okay, so I'm catching up on stuff and reading rather quickly (excuse for less than perfect comprehension)... My first thought when I read this was that it is strong supportive fact to any FDA approval (or pending approval), but not a way to bypass FDA. Could, possibly, be a way to recommend proper usage other than label. I am not a doctor and do not play one on TV.
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Post by sayhey24 on Mar 22, 2017 5:12:59 GMT -5
I've started reading the "Patent" but it isn't clear what the patent is for... Is there a patent lawyer in the house?They use "Ultrarapid" acting several times... Is the intention to establish what Ulta means before getting the Label for Afrezza changed?The patent reads more like a superiority trial, attempting to demonstrate that Ultarapid acting insulin should be part of the "standard" treatment for diabetes (in many situations). Is MannKind trying to use "patent pending" as a way to recommend the proper way to use Afrezza, rather than what's on the Label?Is MannKind trying to (in some way) bypass dealing with the FDA?Anyone able to contact Matt for clarification? Okay, so I'm catching up on stuff and reading rather quickly (excuse for less than perfect comprehension)... My first thought when I read this was that it is strong supportive fact to any FDA approval (or pending approval), but not a way to bypass FDA. Could, possibly, be a way to recommend proper usage other than label. I am not a doctor and do not play one on TV. They are patenting the approach in using afrezza. Remember the Vdex protocol? Now Mannkind licenses the treatment protocol to these service companies like Vdex and Ondou. My comment on metformin is metformin messes up the way the liver works. afrezza will take putting it into meal time mode but the liver needs to be able to get back into the fasting state and produce glucose to prevent hypos. Metformin messes that up.
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Post by kc on Mar 22, 2017 8:54:43 GMT -5
Finally - the new dosing instructions for the new label from the clamp studies. I would have liked it better if they went stronger after metformin and said just throw it in the trash as it will just mess up proper liver function. Now, the next step are the associated computer models which take all this info on dosing and marry it with real time data from the CGMs and tell the PWD how to dose so they don't need to read all that "label" stuff and figure it out on their own. What did Josh Riff say at the Digital Diabetes Congress the other week about the future - easy ways to tell PWD how to dose and a new way to take insulin. Sehey, The problem with your idea is that Metformin cost nothing so Doctors/Insurance companies use it as its cheap.
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Post by agedhippie on Mar 22, 2017 9:12:07 GMT -5
Finally - the new dosing instructions for the new label from the clamp studies. I would have liked it better if they went stronger after metformin and said just throw it in the trash as it will just mess up proper liver function. Now, the next step are the associated computer models which take all this info on dosing and marry it with real time data from the CGMs and tell the PWD how to dose so they don't need to read all that "label" stuff and figure it out on their own. What did Josh Riff say at the Digital Diabetes Congress the other week about the future - easy ways to tell PWD how to dose and a new way to take insulin. Sehey, The problem with your idea is that Metformin cost nothing so Doctors/Insurance companies use it as its cheap. That's the thing metformin is dirt cheap and effective. Given the huge numbers who take it any significant issues would have shown decades ago and since they haven't found significant common side effects this gives a high level of confidence that it has an excellent safety profile. Why take metformin and insulin? Because metformin reduces insulin resistance and hence the amount of basal insulin you require. The weight loss combined with the savings in insulin costs makes this a win/win so there is no way that changes. The bottom line is that metformin is amazingly safe and as such insulin will not displace it even if it is more effective. Costs are crippling health services and if they can get good enough results on a drug that costs cents a month vs. insulin costing hundreds of dollars per month there are no prizes for guessing how this goes.
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Post by peppy on Mar 22, 2017 9:19:24 GMT -5
Sehey, The problem with your idea is that Metformin cost nothing so Doctors/Insurance companies use it as its cheap. That's the thing metformin is dirt cheap and effective. Given the huge numbers who take it any significant issues would have shown decades ago and since they haven't found significant common side effects this gives a high level of confidence that it has an excellent safety profile. Why take metformin and insulin? Because metformin reduces insulin resistance and hence the amount of basal insulin you require. The weight loss combined with the savings in insulin costs makes this a win/win so there is no way that changes. The bottom line is that metformin is amazingly safe and as such insulin will not displace it even if it is more effective. Costs are crippling health services and if they can get good enough results on a drug that costs cents a month vs. insulin costing hundreds of dollars per month there are no prizes for guessing how this goes. The standards of care metformin is given with insulin. fast acting and basal dual therapy. quote: Why take metformin and insulin? Because metformin reduces insulin resistance and hence the amount of basal insulin you require.
reply: since this dirt cheap med effects the liver production of glucose it was needed with fast acting mealtime insulin, because fast acting insulin only gives the phase two insulin reaction? consider, since afrezza has a phase one and phase two, this dirt cheap chemical is not required?
Medicine killing us softly with it's song?
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Post by agedhippie on Mar 22, 2017 9:34:03 GMT -5
That's the thing metformin is dirt cheap and effective. Given the huge numbers who take it any significant issues would have shown decades ago and since they haven't found significant common side effects this gives a high level of confidence that it has an excellent safety profile. Why take metformin and insulin? Because metformin reduces insulin resistance and hence the amount of basal insulin you require. The weight loss combined with the savings in insulin costs makes this a win/win so there is no way that changes. The bottom line is that metformin is amazingly safe and as such insulin will not displace it even if it is more effective. Costs are crippling health services and if they can get good enough results on a drug that costs cents a month vs. insulin costing hundreds of dollars per month there are no prizes for guessing how this goes. The standards of care metformin is given with insulin. fast acting and basal dual therapy. quote: Why take metformin and insulin? Because metformin reduces insulin resistance and hence the amount of basal insulin you require.
reply: since this dirt cheap med effects the liver production of glucose it was needed with fast acting mealtime insulin, because fast acting insulin only gives the phase two insulin reaction? consider, since afrezza has a phase one and phase two, this dirt cheap chemical is not required?
Medicine killing us softly with it's song? Metfomin isn't for meals (it's pretty useless for that), it's for basal. It only impacts meals in so far as it allows you to avoid wasting your natural insulin on basal needs and instead to use it for meals. Afrezza lacks a phase 2 unless you take a second dose which is going to be a problem in wide adoption.
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Post by peppy on Mar 22, 2017 9:37:25 GMT -5
The standards of care metformin is given with insulin. fast acting and basal dual therapy. quote: Why take metformin and insulin? Because metformin reduces insulin resistance and hence the amount of basal insulin you require.
reply: since this dirt cheap med effects the liver production of glucose it was needed with fast acting mealtime insulin, because fast acting insulin only gives the phase two insulin reaction? consider, since afrezza has a phase one and phase two, this dirt cheap chemical is not required?
Medicine killing us softly with it's song? Metfomin isn't for meals (it's pretty useless for that), it's for basal. It only impacts meals in so far as it allows you to avoid wasting your natural insulin on basal needs and instead to use it for meals. Afrezza lacks a phase 2 unless you take a second dose which is going to be a problem in wide adoption. CLINICAL PHARMACOLOGY Mechanism of Action Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects (except in special circumstances, see PRECAUTIONS) and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease. packageinserts.bms.com/pi/pi_glucophage.pdf
added: at least there is a "known" mechanism of action with metformin. so many mechanism of action on pharmaceuticals the mechanism of action is unknown. (I think because they start out with mice. Give the mice a condition. Give mice chemical assortments and then see if the chemical affected the condition and then go from there. they run a study to try to show effectiveness. and have no clue why it "seems" to work in some regard.)
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