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Post by mnholdem on May 15, 2015 10:00:31 GMT -5
Afrezza sales WILL explode. Ummmm, but in the meantime... I've provided the link to the FDA site that lists the four pending Post-Approval trials for Afrezza.
It's interesting that three are listed as Status: "Pending". However, the Pediatric Trial displays Status: "The study has not been initiated, but does not meet the criterion for delayed." (see below)
www.accessdata.fda.gov/scripts/cder/pmc/index.cfm (you need to click the Search button)
Post-Approval Trials (listed in order of original projected completion date):
Requirement/Commitment Number: 3 Original Projected Completion Date: 1/31/2017 Description: A PK-PD eugylcemic glucose-clamp trial to characterize within-subject variability for Afrezza pharmacokinetic (PK) and pharmacodynamic (PD) parameters. These data may impact labeling recommendations for glucose monitoring and thereby mitigate the risk of hypoglycemia, which has been observed with Afrezza. Status: Pending
Requirement/Commitment Number: 2
Original Projected Completion Date: 3/31/2017
Description: Conduct a dose-ranging PK-PD euglycemic glucose-clamp trial to characterize the dose-response of Afrezza relative to subcutaneous insulin in patients with type 1 diabetes. Select at least three to four doses for each route of insulin administration to ensure both the linear and curvilinear portions of the dose-response curves are adequately captured and characterized. Compare the dose-response curves for Afrezza and subcutaneous insulin noting the dose at which the response becomes curvilinear for each. These data may impact labeling recommendations for dosing and thereby mitigate the risk of diabetic ketoacidosis, which has been observed with Afrezza. Status: Pending
Requirement/Commitment Number: 1
Original Projected Completion Date: 1/31/2021
Description: An open-label pharmacokinetic (PK), and multiple-dose safety and tolerability dose-titration trial of Afrezza in pediatric patients ages 4 to 17 years (inclusive) with type 1 diabetes (Part 1), followed by a prospective, multicenter, open-label, randomized, controlled trial comparing the efficacy and safety of prandial Afrezza to prandial subcutaneous insulin aspart used in combination with subcutaneous basal insulin in pediatric patients 4 to 17 years old (inclusive) with type 1 or type 2 diabetes (Part 2). Part 2 of the trial should include a 4-week run-in phase and a 52-week randomized intervention phase. Status: The study has not been initiated, but does not meet the criterion for delayed.
Requirement/Commitment Number: 4
Original Projected Completion Date: 12/31/2023
Description: Conduct a 5-year, randomized, controlled trial in 8,000-10,000 patients with type 2 diabetes to assess the serious potential risk of pulmonary malignancy with Afrezza use. The primary objective of the trial should be to compare the incidence of pulmonary malignancy observed with Afrezza to that observed in the standard of care control group. Secondary endpoints should include mortality due to pulmonary malignancy and all-cause mortality. Randomization to Afrezza or standard of care should be 1 to 1. The patient population should be enriched with respect to lung cancer risk (i.e., predicted incidence of no less than 200/100,000 patient-year). The potential for detection bias should be adequately addressed in the trial design. Subjects who discontinue randomized intervention due to lack of efficacy or tolerability issues should continue to be followed for the outcomes of interest and prospective measures to encourage subject retention and capture outcomes in patients who withdraw or are lost to follow-up should be in place. Glucose control and glycemic rescue should be per standard of care. The trial must also include an assessment of cardiovascular risk based on prospectively defined, collected and independently adjudicated major adverse cardiovascular events or MACE (i.e., cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke). Also include as part of the trial a substudy (also with 1 to 1 randomization to either Afrezza or standard or care) to evaluate the long-term effect of Afrezza on pulmonary function. Patients in the substudy should have pulmonary function tests at baseline and every 6 months until end of treatment. Status: Pending
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Ordinarily, I wouldn't have considered posting this. However, do you remember my post about the dad who got Afrezza prescribed off-label for his teen-aged daughter & son? Before he realized that physicians will prescribe off-label, the dad had previously applied with Sanofi to get his kids enrolled in the pediatric trials. Sanofi told him that the pediatric trials were being postponed until one of Sanofi's production facilities was operational.
Why would opening a new Afrezza production facility cause a delay the pediatric trials? I don't think the dad misunderstood. Correct me if I'm wrong, but aren't trial patents given Afrezza free of charge? Could the purpose of this delay be that Sanofi wants to hold down the costs of the trials?
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Post by Deleted on May 15, 2015 10:07:15 GMT -5
Why would opening a new Afrezza production facility cause a delay the pediatric trials? I don't think the dad misunderstood. Correct me if I'm wrong, but aren't trial patents given Afrezza free of charge? Could the purpose of this delay be that Sanofi wants to hold down the costs of the trials?
May be make use Sanofi's insulin in the trials so it serves two purposes? just a guess |
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Post by esstan2001 on May 15, 2015 10:43:40 GMT -5
Why would opening a new Afrezza production facility cause a delay the pediatric trials? I don't think the dad misunderstood. Correct me if I'm wrong, but aren't trial patents given Afrezza free of charge? Could the purpose of this delay be that Sanofi wants to hold down the costs of the trials?
May be make use Sanofi's insulin in the trials so it serves two purposes? just a guess I think that before the FDA permits any public use of the Sanofi insulin, they must test to show bio-equivalence just like Mannkind had to do for thier new lines to get green-lighted in the same factory. |
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Post by esstan2001 on May 15, 2015 10:49:55 GMT -5
to elaborate, Sanofi Afrezza production would be a long range cost savings measure once serious volumes are demonstrated. And that is a good point to add pediatrics to the label. From what I've gathered on this board, a pediatric indication is not worth the investment at this early stage because docs will just prescribe off label if they are comfortable with Afrezza, and if things go as many here expect, that should kick off as we approach a year give or take.
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Post by harryx1 on May 15, 2015 10:55:04 GMT -5
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Post by lakers on Dec 18, 2015 2:37:53 GMT -5
Now that Pediatric Trial started recruiting since Oct 2015, Sny insulin qualification must be just completed very recently. As such, Mnkd will get $25M dev in 1Q16. Pediatric Phase 1 should finish 1Q16. The 8-10K PWD lung trial w/ protocol decided by 4/30/16 w/ FDA and EMA will cause a huge increase in free TRx of which cost will be borned by Sanofi alone. Thus, Sanofi has an incentive to supply its insulin for Afrezza to minimize the expense. Things are coming together finally.
Matt's slides showed Mnkd has been qualifying Sanofi's insulin and planning international expansion. This is to be followed by label improvement, superiority trials of which protocol would be forklifted from the 12 early adopters' experience shared at Del Mar Hilton, SD. It all makes sense now.
Sanofi needs to obtain superiority label to justify charging high price and move Afrezza to Tier 2. Although I don't want to recommend any investment, what liane has been doing made sense.
Hope these bring visibility and clarity to the Old Faithful's.
BTW, Matt is traveling on a business trip. His email response will be slow. Roberta will be back tomorrow Fri.
You can verify all these if you don't want to take them with a grain of salt. I recommend you at least try before passing judgment.
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Post by lakers on Dec 18, 2015 15:38:50 GMT -5
A Guest Post on Afrezza by Jeremy Pettus I wanted Dr. Jeremy Pettus to write today about Afrezza. My tune on this med has changed slightly after Dr. Steve Edelman and I put on a very interesting focus group on a during the first weekend of December to discuss the medication. The purpose of the group was to learn how successful Afrezza users use Afrezza successfully (say that 10 times fast!) with the intent of designing a clinical trial around this info. Read more: mnkd.proboards.com/user/1882/recent#ixzz3uht2OYR4 |
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Post by bill on Dec 18, 2015 16:17:46 GMT -5
Afrezza sales WILL explode. Ummmm, but in the meantime... I've provided the link to the FDA site that lists the four pending Post-Approval trials for Afrezza.
It's interesting that three are listed as Status: "Pending". However, the Pediatric Trial displays Status: "The study has not been initiated, but does not meet the criterion for delayed." (see below)
www.accessdata.fda.gov/scripts/cder/pmc/index.cfm (you need to click the Search button)
Post-Approval Trials (listed in order of original projected completion date):
Requirement/Commitment Number: 3 Original Projected Completion Date: 1/31/2017 Description: A PK-PD eugylcemic glucose-clamp trial to characterize within-subject variability for Afrezza pharmacokinetic (PK) and pharmacodynamic (PD) parameters. These data may impact labeling recommendations for glucose monitoring and thereby mitigate the risk of hypoglycemia, which has been observed with Afrezza. Status: Pending
Requirement/Commitment Number: 2
Original Projected Completion Date: 3/31/2017
Description: Conduct a dose-ranging PK-PD euglycemic glucose-clamp trial to characterize the dose-response of Afrezza relative to subcutaneous insulin in patients with type 1 diabetes. Select at least three to four doses for each route of insulin administration to ensure both the linear and curvilinear portions of the dose-response curves are adequately captured and characterized. Compare the dose-response curves for Afrezza and subcutaneous insulin noting the dose at which the response becomes curvilinear for each. These data may impact labeling recommendations for dosing and thereby mitigate the risk of diabetic ketoacidosis, which has been observed with Afrezza. Status: Pending
Requirement/Commitment Number: 1
Original Projected Completion Date: 1/31/2021
Description: An open-label pharmacokinetic (PK), and multiple-dose safety and tolerability dose-titration trial of Afrezza in pediatric patients ages 4 to 17 years (inclusive) with type 1 diabetes (Part 1), followed by a prospective, multicenter, open-label, randomized, controlled trial comparing the efficacy and safety of prandial Afrezza to prandial subcutaneous insulin aspart used in combination with subcutaneous basal insulin in pediatric patients 4 to 17 years old (inclusive) with type 1 or type 2 diabetes (Part 2). Part 2 of the trial should include a 4-week run-in phase and a 52-week randomized intervention phase. Status: The study has not been initiated, but does not meet the criterion for delayed.
Requirement/Commitment Number: 4
Original Projected Completion Date: 12/31/2023
Description: Conduct a 5-year, randomized, controlled trial in 8,000-10,000 patients with type 2 diabetes to assess the serious potential risk of pulmonary malignancy with Afrezza use. The primary objective of the trial should be to compare the incidence of pulmonary malignancy observed with Afrezza to that observed in the standard of care control group. Secondary endpoints should include mortality due to pulmonary malignancy and all-cause mortality. Randomization to Afrezza or standard of care should be 1 to 1. The patient population should be enriched with respect to lung cancer risk (i.e., predicted incidence of no less than 200/100,000 patient-year). The potential for detection bias should be adequately addressed in the trial design. Subjects who discontinue randomized intervention due to lack of efficacy or tolerability issues should continue to be followed for the outcomes of interest and prospective measures to encourage subject retention and capture outcomes in patients who withdraw or are lost to follow-up should be in place. Glucose control and glycemic rescue should be per standard of care. The trial must also include an assessment of cardiovascular risk based on prospectively defined, collected and independently adjudicated major adverse cardiovascular events or MACE (i.e., cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke). Also include as part of the trial a substudy (also with 1 to 1 randomization to either Afrezza or standard or care) to evaluate the long-term effect of Afrezza on pulmonary function. Patients in the substudy should have pulmonary function tests at baseline and every 6 months until end of treatment. Status: Pending
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Ordinarily, I wouldn't have considered posting this. However, do you remember my post about the dad who got Afrezza prescribed off-label for his teen-aged daughter & son? Before he realized that physicians will prescribe off-label, the dad had previously applied with Sanofi to get his kids enrolled in the pediatric trials. Sanofi told him that the pediatric trials were being postponed until one of Sanofi's production facilities was operational.
Why would opening a new Afrezza production facility cause a delay the pediatric trials? I don't think the dad misunderstood. Correct me if I'm wrong, but aren't trial patents given Afrezza free of charge? Could the purpose of this delay be that Sanofi wants to hold down the costs of the trials?
I wonder if SNY had more reasons than just cost behind their wanting to use their own production facility. Perhaps their facility would be capable of producing a 2U cartridge. Wouldn't it make sense that someone as young as 4 years old might need something less than a 4U cartridge for at least some of their doses? Kills multiple birds with a single stone; SNY facility gets accredited, SNY's facility has lower costs, 2U cartridge gets accredited for use by anyone who needs it, and it sets up a production capability that can support international expansion. |
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Post by Deleted on Dec 18, 2015 16:32:12 GMT -5
Afrezza sales WILL explode. Ummmm, but in the meantime... I've provided the link to the FDA site that lists the four pending Post-Approval trials for Afrezza.
It's interesting that three are listed as Status: "Pending". However, the Pediatric Trial displays Status: "The study has not been initiated, but does not meet the criterion for delayed." (see below)
www.accessdata.fda.gov/scripts/cder/pmc/index.cfm (you need to click the Search button)
Post-Approval Trials (listed in order of original projected completion date):
Requirement/Commitment Number: 3 Original Projected Completion Date: 1/31/2017 Description: A PK-PD eugylcemic glucose-clamp trial to characterize within-subject variability for Afrezza pharmacokinetic (PK) and pharmacodynamic (PD) parameters. These data may impact labeling recommendations for glucose monitoring and thereby mitigate the risk of hypoglycemia, which has been observed with Afrezza. Status: Pending
Requirement/Commitment Number: 2
Original Projected Completion Date: 3/31/2017
Description: Conduct a dose-ranging PK-PD euglycemic glucose-clamp trial to characterize the dose-response of Afrezza relative to subcutaneous insulin in patients with type 1 diabetes. Select at least three to four doses for each route of insulin administration to ensure both the linear and curvilinear portions of the dose-response curves are adequately captured and characterized. Compare the dose-response curves for Afrezza and subcutaneous insulin noting the dose at which the response becomes curvilinear for each. These data may impact labeling recommendations for dosing and thereby mitigate the risk of diabetic ketoacidosis, which has been observed with Afrezza. Status: Pending
Requirement/Commitment Number: 1
Original Projected Completion Date: 1/31/2021
Description: An open-label pharmacokinetic (PK), and multiple-dose safety and tolerability dose-titration trial of Afrezza in pediatric patients ages 4 to 17 years (inclusive) with type 1 diabetes (Part 1), followed by a prospective, multicenter, open-label, randomized, controlled trial comparing the efficacy and safety of prandial Afrezza to prandial subcutaneous insulin aspart used in combination with subcutaneous basal insulin in pediatric patients 4 to 17 years old (inclusive) with type 1 or type 2 diabetes (Part 2). Part 2 of the trial should include a 4-week run-in phase and a 52-week randomized intervention phase. Status: The study has not been initiated, but does not meet the criterion for delayed.
Requirement/Commitment Number: 4
Original Projected Completion Date: 12/31/2023
Description: Conduct a 5-year, randomized, controlled trial in 8,000-10,000 patients with type 2 diabetes to assess the serious potential risk of pulmonary malignancy with Afrezza use. The primary objective of the trial should be to compare the incidence of pulmonary malignancy observed with Afrezza to that observed in the standard of care control group. Secondary endpoints should include mortality due to pulmonary malignancy and all-cause mortality. Randomization to Afrezza or standard of care should be 1 to 1. The patient population should be enriched with respect to lung cancer risk (i.e., predicted incidence of no less than 200/100,000 patient-year). The potential for detection bias should be adequately addressed in the trial design. Subjects who discontinue randomized intervention due to lack of efficacy or tolerability issues should continue to be followed for the outcomes of interest and prospective measures to encourage subject retention and capture outcomes in patients who withdraw or are lost to follow-up should be in place. Glucose control and glycemic rescue should be per standard of care. The trial must also include an assessment of cardiovascular risk based on prospectively defined, collected and independently adjudicated major adverse cardiovascular events or MACE (i.e., cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke). Also include as part of the trial a substudy (also with 1 to 1 randomization to either Afrezza or standard or care) to evaluate the long-term effect of Afrezza on pulmonary function. Patients in the substudy should have pulmonary function tests at baseline and every 6 months until end of treatment. Status: Pending
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Ordinarily, I wouldn't have considered posting this. However, do you remember my post about the dad who got Afrezza prescribed off-label for his teen-aged daughter & son? Before he realized that physicians will prescribe off-label, the dad had previously applied with Sanofi to get his kids enrolled in the pediatric trials. Sanofi told him that the pediatric trials were being postponed until one of Sanofi's production facilities was operational.
Why would opening a new Afrezza production facility cause a delay the pediatric trials? I don't think the dad misunderstood. Correct me if I'm wrong, but aren't trial patents given Afrezza free of charge? Could the purpose of this delay be that Sanofi wants to hold down the costs of the trials?
I wonder if SNY had more reasons than just cost behind their wanting to use their own production facility. Perhaps their facility would be capable of producing a 2U cartridge. Wouldn't it make sense that someone as young as 4 years old might need something less than a 4U cartridge for at least some of their doses? Kills multiple birds with a single stone; SNY facility gets accredited, SNY's facility has lower costs, 2U cartridge gets accredited for use by anyone who needs it, and it sets up a production capability that can support international expansion. Bill, for the purposes of the pediatric trial, it was said that Afrezza in 2U configuration could be made at the Danbury plants pilot production line. In this thread, there is one comment about getting Sanofi insulin certified and Bill has mentioned the SNY facility getting accredited. Two different things. Are you talking about the Sanofi plant in Germany and has it been accredited or whatever it is called in Europe? A few months back, Mannkind got an approval for free trade zone and / or import / export license for Danbury and at the time, others speculated it was to be able to bring in Sanofi insulin (Amphastar as well?). |
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Post by bill on Dec 18, 2015 19:34:02 GMT -5
@scotta I don't have any good answers to your questions, but it does seems that some to most of the items mentioned are in play. If so, it's all good news. SNY is committed and 2016 sales will definitely pick up. The biggest outstanding issues are whether / if MNKD cuts a good TS deal or two quickly, and/or something positive changes in the SNY / MNKD partnership, e.g., milestone payments, buy-out, or something else. With all this good news slowly emerging it's clear the stock price remains very disconnected from current events. But we've known that for a while. I suspect the institutional investors are playing the shorts game. They're going to patiently wait for some clear positive news and then land on the shorts all at once in unison.
It will be fun to be a spectator when that happens.
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Post by tommix321 on Dec 18, 2015 22:46:33 GMT -5
Afrezza sales WILL explode. Ummmm, but in the meantime... I've provided the link to the FDA site that lists the four pending Post-Approval trials for Afrezza.
It's interesting that three are listed as Status: "Pending". However, the Pediatric Trial displays Status: "The study has not been initiated, but does not meet the criterion for delayed." (see below)
www.accessdata.fda.gov/scripts/cder/pmc/index.cfm (you need to click the Search button)
Post-Approval Trials (listed in order of original projected completion date):
Requirement/Commitment Number: 3 Original Projected Completion Date: 1/31/2017 Description: A PK-PD eugylcemic glucose-clamp trial to characterize within-subject variability for Afrezza pharmacokinetic (PK) and pharmacodynamic (PD) parameters. These data may impact labeling recommendations for glucose monitoring and thereby mitigate the risk of hypoglycemia, which has been observed with Afrezza. Status: Pending
Requirement/Commitment Number: 2
Original Projected Completion Date: 3/31/2017
Description: Conduct a dose-ranging PK-PD euglycemic glucose-clamp trial to characterize the dose-response of Afrezza relative to subcutaneous insulin in patients with type 1 diabetes. Select at least three to four doses for each route of insulin administration to ensure both the linear and curvilinear portions of the dose-response curves are adequately captured and characterized. Compare the dose-response curves for Afrezza and subcutaneous insulin noting the dose at which the response becomes curvilinear for each. These data may impact labeling recommendations for dosing and thereby mitigate the risk of diabetic ketoacidosis, which has been observed with Afrezza. Status: Pending
Requirement/Commitment Number: 1
Original Projected Completion Date: 1/31/2021
Description: An open-label pharmacokinetic (PK), and multiple-dose safety and tolerability dose-titration trial of Afrezza in pediatric patients ages 4 to 17 years (inclusive) with type 1 diabetes (Part 1), followed by a prospective, multicenter, open-label, randomized, controlled trial comparing the efficacy and safety of prandial Afrezza to prandial subcutaneous insulin aspart used in combination with subcutaneous basal insulin in pediatric patients 4 to 17 years old (inclusive) with type 1 or type 2 diabetes (Part 2). Part 2 of the trial should include a 4-week run-in phase and a 52-week randomized intervention phase. Status: The study has not been initiated, but does not meet the criterion for delayed.
Requirement/Commitment Number: 4
Original Projected Completion Date: 12/31/2023
Description: Conduct a 5-year, randomized, controlled trial in 8,000-10,000 patients with type 2 diabetes to assess the serious potential risk of pulmonary malignancy with Afrezza use. The primary objective of the trial should be to compare the incidence of pulmonary malignancy observed with Afrezza to that observed in the standard of care control group. Secondary endpoints should include mortality due to pulmonary malignancy and all-cause mortality. Randomization to Afrezza or standard of care should be 1 to 1. The patient population should be enriched with respect to lung cancer risk (i.e., predicted incidence of no less than 200/100,000 patient-year). The potential for detection bias should be adequately addressed in the trial design. Subjects who discontinue randomized intervention due to lack of efficacy or tolerability issues should continue to be followed for the outcomes of interest and prospective measures to encourage subject retention and capture outcomes in patients who withdraw or are lost to follow-up should be in place. Glucose control and glycemic rescue should be per standard of care. The trial must also include an assessment of cardiovascular risk based on prospectively defined, collected and independently adjudicated major adverse cardiovascular events or MACE (i.e., cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke). Also include as part of the trial a substudy (also with 1 to 1 randomization to either Afrezza or standard or care) to evaluate the long-term effect of Afrezza on pulmonary function. Patients in the substudy should have pulmonary function tests at baseline and every 6 months until end of treatment. Status: Pending
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Ordinarily, I wouldn't have considered posting this. However, do you remember my post about the dad who got Afrezza prescribed off-label for his teen-aged daughter & son? Before he realized that physicians will prescribe off-label, the dad had previously applied with Sanofi to get his kids enrolled in the pediatric trials. Sanofi told him that the pediatric trials were being postponed until one of Sanofi's production facilities was operational.
Why would opening a new Afrezza production facility cause a delay the pediatric trials? I don't think the dad misunderstood. Correct me if I'm wrong, but aren't trial patents given Afrezza free of charge? Could the purpose of this delay be that Sanofi wants to hold down the costs of the trials?
The FDA tends to be somewhat slack in updating status. The "within-subject variability for Afrezza" and "the dose-response of Afrezza relative to subcutaneous insulin" trials have been completed even though the FDA lists them as "pending," which, as the FDA uses the term, means the study hasn't even started enrolling subjects: FDA terminolgyConsequently, who really knows what the FDA means by "the study has not been initiated, but does not meet the criterion for delayed"? Per that link, "does not meet the criterion for delayed" means "the original projected date for initiation of patient accrual or initiation of animal dosing has not passed." I suspect that when they wrote that for the peds study, it still hadn't started recruiting, but had not yet reached the FDA's assigned date to begin recruiting. The postponement for a month of the pediatric study "start date" is more curious. Why one month -- from September to October? Why even file the change if only one month? Beats me. |
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Post by mnholdem on Dec 18, 2015 23:56:59 GMT -5
You might want to look at the date of my OP. I don't think that lakers needed to bump this thread to make his point about Sanofi, since the subject has resurfaced a few times.
Obviously, the trials have been completed since I postulated in May. It may seem that very little else has been accomplished by Sanofi, but appearances can be deceiving, n'est ce pas?
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Post by cathode on Dec 19, 2015 12:53:00 GMT -5
Bill, for the purposes of the pediatric trial, it was said that Afrezza in 2U configuration could be made at the Danbury plants pilot production line. In this thread, there is one comment about getting Sanofi insulin certified and Bill has mentioned the SNY facility getting accredited. Two different things. Are you talking about the Sanofi plant in Germany and has it been accredited or whatever it is called in Europe? A few months back, Mannkind got an approval for free trade zone and / or import / export license for Danbury and at the time, others speculated it was to be able to bring in Sanofi insulin (Amphastar as well?). Here is the Foreign Trade Subzone Application. ita-web.ita.doc.gov/FTZ/OFISLogin.nsf/cebfcbe7628314e6852576ef005f9ca4/334b7dbf612bc1c585257ef80047e06e/$FILE/Doc.%20S-147-2015%20Application.pdfIn section 5 it states that the purpose of the Subzone status is for importation of FDKP and combination with domestic materials. I don't really understand how Amphastar insulin fits into the domestic materials... |
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