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Post by mike0475 on Dec 26, 2015 10:19:13 GMT -5
Lakers, since this thread was started by you - a question for you if you dont mind answering. Was Desisto suppose to take over for Mann originally, do you know? Was Hakan an interim position that he wanted to take as perm, and then was removed?
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Post by kc on Dec 26, 2015 11:07:35 GMT -5
I would like to see MNKD start a long term study on pre diabetics to assess whether AFZ can stop the progression of disease.  I remember reading somewhere or perhaps Al stated that Afrezza would give the body or pancreas restorative ability to slow down or prevent becoming a full blown diabetic. That in itself worth the prescription price for preventative care for a healthcare insurer. |
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Post by suebeeee1 on Dec 26, 2015 13:48:50 GMT -5
I would like to see MNKD start a long term study on pre diabetics to assess whether AFZ can stop the progression of disease. I remember reading somewhere or perhaps Al stated that Afrezza would give the body or pancreas restorative ability to slow down or prevent becoming a full blown diabetic. That in itself worth the prescription price for preventative care for a healthcare insurer. Seems that a few diabetics are experiencing a need for smaller amounts of Afrezza to keep their bg under control. My husband started out at a higher amount at each meal than he uses now to get the same effect. Interested in what the long term effect will be for everyone. |
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Post by Deleted on Dec 26, 2015 14:05:05 GMT -5
Real news on next 2 in the pipeline or EU approval? Sanofi hasn't filed EMA, ME MAA's yet. But that may change next year. Sanofi is obligated to inform Mnkd immediately after they file. I agree that superiority clinical study duration is about 7 mos after recruiting ends, long enough to measure A1C at least once or twice, hypo events, weight loss, cardio events, lung capacity at least once after 6 mos, time in range, 46 participants. The big Q is will Sanofi wait till the superiority trial finishes to file MAA or file it first, then apply for label change just before final approval b/c the longest pole will be 210 days max coinciding w/ 7-mo superiority trial. Regardless, all analysts covering Mnkd agreed that MAA would be a catalyst for pps. Next partnership will be pain, migraine mgmt, ready for human clinical trials. what kind of terms do you anticipate? pain as in opiods? ( if so huge market?) |
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Post by pktrump on Dec 26, 2015 15:34:09 GMT -5
I think the superiority trial is the most important in the short term, but in the Long term, if AFZ is shown to halt progression
of disease from pre diabetic to full blown type II hyerinsulinemia/insulin resistance, elevating A1C levels, loss of phase I response etc.. this would
be the test heard around the medical world. Instead of the status quo of initiating Oral hypoglycemics after A1C reaches a certain level, replace with
(insulin) AFZ therapy 'prior to A1C reaching diabetic levels' would become the status quo. In the process, it would save billions in healthcare costs and turn
the tide in an out of control epidemic.
In theory AFZ should work to do just that, i.e prevent progression to type II. If that were proven thru a well designed study, the word disruptive would not be strong enough to describe the impact. At a Deutsche Biotech conference in Boston ? 2009, 2010 time frame, Al was asked by a young analyst in the conference room this question regarding prevention. Al responded
with a confident yes.
What in the world is SNY waiting on?
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Post by factspls88 on Dec 26, 2015 16:32:18 GMT -5
I think the superiority trial is the most important in the short term, but in the Long term, if AFZ is shown to halt progression of disease from pre diabetic to full blown type II hyerinsulinemia/insulin resistance, elevating A1C levels, loss of phase I response etc.. this would be the test heard around the medical world. Instead of the status quo of initiating Oral hypoglycemics after A1C reaches a certain level, replace with (insulin) AFZ therapy ' prior to A1C reaching diabetic levels' would become the status quo. In the process, it would save billions in healthcare costs and turn the tide in an out of control epidemic. In theory AFZ should work to do just that, i.e prevent progression to type II. If that were proven thru a well designed study, the word disruptive would not be strong enough to describe the impact. At a Deutsche Biotech conference in Boston ? 2009, 2010 time frame, Al was asked by a young analyst in the conference room this question regarding prevention. Al responded with a confident yes. What in the world is SNY waiting on?
Re your statement bolded and in red: In my opinion Sanofi would not see it as in their best interest to demonstrate that Afrezza to reverses or halts the progression of the disease - hence the foot dragging. After all, they have a diabetes franchise to protect. I believe that best case for them would be for Afrezza to conclusively show superiority in managing diabetes, i.e. reducing significant high and low swings, as well as demonstrating a significant reduction in the incidence of hypoglycemia. Sorry for the cynicism, but..... |
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Post by greg on Dec 26, 2015 16:53:22 GMT -5
"After all, they have a diabetes franchise to protect."
Isn't Afrezza part of that franchise, after all SNY owns 65% of the economic interest and Lantus is under considerable pressure.
It's obviously in their financial interest to maximize returns on Afrezza, even if it means contributions from Toujeo and Lantus are affected adversely, which may or may not be the case.
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Post by longstocking on Dec 26, 2015 17:02:00 GMT -5
I think the superiority trial is the most important in the short term, but in the Long term, if AFZ is shown to halt progression of disease from pre diabetic to full blown type II hyerinsulinemia/insulin resistance, elevating A1C levels, loss of phase I response etc.. this would be the test heard around the medical world. Instead of the status quo of initiating Oral hypoglycemics after A1C reaches a certain level, replace with (insulin) AFZ therapy ' prior to A1C reaching diabetic levels' would become the status quo. In the process, it would save billions in healthcare costs and turn the tide in an out of control epidemic. In theory AFZ should work to do just that, i.e prevent progression to type II. If that were proven thru a well designed study, the word disruptive would not be strong enough to describe the impact. At a Deutsche Biotech conference in Boston ? 2009, 2010 time frame, Al was asked by a young analyst in the conference room this question regarding prevention. Al responded with a confident yes. What in the world is SNY waiting on?
Re your statement bolded and in red: In my opinion Sanofi would not see it as in their best interest to demonstrate that Afrezza to reverses or halts the progression of the disease - hence the foot dragging. After all, they have a diabetes franchise to protect. I believe that best case for them would be for Afrezza to conclusively show superiority in managing diabetes, i.e. reducing significant high and low swings, as well as demonstrating a significant reduction in the incidence of hypoglycemia. Sorry for the cynicism, but..... Unless they owned 100% of Afrezza. |
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Post by factspls88 on Dec 27, 2015 11:51:36 GMT -5
"After all, they have a diabetes franchise to protect." Isn't Afrezza part of that franchise, after all SNY owns 65% of the economic interest and Lantus is under considerable pressure. It's obviously in their financial interest to maximize returns on Afrezza, even if it means contributions from Toujeo and Lantus are affected adversely, which may or may not be the case. Right now Lantus and Toujeo comprise such a huge percent of their profits that I believe they are Sanofi's first priority. They would not be able to support Afrezza to a significant degree without the continued profit contribution. Yes, they want Afrezza to be successful, but I don't see them being in any hurry to prove that Afrezza could be a potential cure for diabetes, at least for type 2's. I just don't believe that Sanofi has the vision and the social largesse to do so as do so since those type 2's eventually feed into their existing basal insulin franchise. Personally I wish they would, but I don't see the folks at Sanofi as particularly visionary and altruistic. In the meantime, superior management of diabetes is a great product positioning for Afrezza, as it allows for all of Sanofi's insulins to co-exist and complement one another. |
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Post by mnholdem on Dec 27, 2015 13:03:46 GMT -5
Perhaps, then, you should consider than the vast majority of early diabetics are prescribed with orals. Sanofi would pick up that huge slice of the market were they to fully develop Afrezza. The study that I posted revealed that early intensive insulin therapy resulted in 40% of early diabetics were able to reverse the progression of the disease and discontinue therapy. The remaining 60% discontinued the intensive insulin therapy, but continued getting treated for the disease. The study revealed that the patients were now less adverse to the idea of taking insulin because they already had received insulin during the initial intensive therapy. That study was conducted with injection. How much less resistant would early diabetics be with an inhalable insulin?
Bottom line is with empirical evidence to prove the effectiveness of Afrezza as a first-line treatment for early T2, Sanofi could capture a big chunk of the oral market while maintaining the demand for basal+prandial control for patients whose pancreas damage cannot be fully restored. Millions are diagnosed too late and for them early intensive insulin therapy won't be in time. Afrezza won't end all diabetes.
However, if Afrezza were to be proven in a therapy leading to a remission for millions of early diabetics, Sanofi could benefit substantially. IMO, they would be portrayed as a pharmaceutical company that is exactly the opposite of what was portrayed by Shkreli.
...all the while Sanofi rakes in $billions by expanding the insulin market to early- and pre-diabetes patients.
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Post by factspls88 on Dec 27, 2015 14:33:34 GMT -5
Perhaps, then, you should consider than the vast majority of early diabetics are prescribed with orals. Sanofi would pick up that huge slice of the market were they to fully develop Afrezza. The study that I posted revealed that early intensive insulin therapy resulted in 40% of early diabetics were able to reverse the progression of the disease and discontinue therapy. The remaining 60% discontinued the intensive insulin therapy, but continued getting treated for the disease. The study revealed that the patients were now less adverse to the idea of taking insulin because they already had received insulin during the initial intensive therapy. That study was conducted with injection. How much less resistant would early diabetics be with an inhalable insulin? Bottom line is with empirical evidence to prove the effectiveness of Afrezza as a first-line treatment for early T2, Sanofi could capture a big chunk of the oral market while maintaining the demand for basal+prandial control for patients whose pancreas damage cannot be fully restored. Millions are diagnosed too late and for them early intensive insulin therapy won't be in time. Afrezza won't end all diabetes. However, if Afrezza were to be proven in a therapy leading to a remission for millions of early diabetics, Sanofi could benefit substantially. IMO, they would be portrayed as a pharmaceutical company that is exactly the opposite of what was portrayed by Shkreli. ...all the while Sanofi rakes in $billions by expanding the insulin market to early- and pre-diabetes patients. I don't necessarily disagree with your "big picture" viewpoint, after all, it has always been their objective to capture a significant share of early T2's on orals and to those T2's who have been non-compliant due to fear of needles. I was responding to the question of why Sanofi was dragging their feet with respect to studies proving Afrezza halts the progression of the disease, and I believe it is because SNY needs to shore up their existing injected insulin franchises which right now are their bread and butter. Positioning Afrezza for now as a diabetes management tool I believe is the course they will likely take until Toujeo takes a strong foothold and compensates for the losses that are inevitable with Lantus. The last thing they want right now, I suspect, is having a new SNY product poised to potentially cannibalize their injected product in the short term while Toujeo is still trying to make its mark. Longer term, I agree completely with you scenario. JMHO |
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Post by suebeeee1 on Dec 27, 2015 17:15:40 GMT -5
Perhaps, then, you should consider than the vast majority of early diabetics are prescribed with orals. Sanofi would pick up that huge slice of the market were they to fully develop Afrezza. The study that I posted revealed that early intensive insulin therapy resulted in 40% of early diabetics were able to reverse the progression of the disease and discontinue therapy. The remaining 60% discontinued the intensive insulin therapy, but continued getting treated for the disease. The study revealed that the patients were now less adverse to the idea of taking insulin because they already had received insulin during the initial intensive therapy. That study was conducted with injection. How much less resistant would early diabetics be with an inhalable insulin? Bottom line is with empirical evidence to prove the effectiveness of Afrezza as a first-line treatment for early T2, Sanofi could capture a big chunk of the oral market while maintaining the demand for basal+prandial control for patients whose pancreas damage cannot be fully restored. Millions are diagnosed too late and for them early intensive insulin therapy won't be in time. Afrezza won't end all diabetes. However, if Afrezza were to be proven in a therapy leading to a remission for millions of early diabetics, Sanofi could benefit substantially. IMO, they would be portrayed as a pharmaceutical company that is exactly the opposite of what was portrayed by Shkreli. ...all the while Sanofi rakes in $billions by expanding the insulin market to early- and pre-diabetes patients. I don't necessarily disagree with your "big picture" viewpoint, after all, it has always been their objective to capture a significant share of early T2's on orals and to those T2's who have been non-compliant due to fear of needles. I was responding to the question of why Sanofi was dragging their feet with respect to studies proving Afrezza halts the progression of the disease, and I believe it is because SNY needs to shore up their existing injected insulin franchises which right now are their bread and butter. Positioning Afrezza for now as a diabetes management tool I believe is the course they will likely take until Toujeo takes a strong foothold and compensates for the losses that are inevitable with Lantus. The last thing they want right now, I suspect, is having a new SNY product poised to potentially cannibalize their injected product in the short term while Toujeo is still trying to make its mark. Longer term, I agree completely with you scenario. JMHO Maybe I am the one who is incapable of seeing the complete picture here. I understand Lantus is going off patent and there will be quite reduction in Sanofi's bottom line unless they can do something quickly to shore up their insulin markets. Afrezza would never have competed with Lantus, or Toujou for that matter. Either should work seamlessly with Afrezza (IF NECESSARY). So there is no market cannibalization there. In addition, Type 2s who have never been on insulin and are "on the line", or should have already started insulin but either patient or doctor is unwilling to go down that path. Perhaps the patient is not really very compliant with testing and would be at risk of either underdosing or hypogylcemia (my husband) or they are trying to put insulin off till the very last moment possible. I think this constitutes the largest number of people in our unmet market. Afrezza is perfect for all these folks! And, it could reverse the course of the disease??? You've got to be kidding right? No one reverses DIABETES! Can you imagine the sale pitch? Doctors could safely prescribe to all the Type 2s out there on orals who they are reluctant to put on insulin. Diabetics who don't want to progress any further and who even may wish to try and reverse their disease will sign up by the millions. Now, I know they can't advertise to reverse the disease, but they sure can say this is an easy, peasy way of control that doesn't involve injections or hypogylcemia risks. Unmet need. Sanofi, lets get with the program here! We could capture the whole darn market here! Hmmm....of course these Type 2s may never then get to the point where they need a basal insulin as well as a prandial... So their market strategy is one where they WANT Type 2s to be sicker??? |
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Post by mnholdem on Dec 27, 2015 18:33:30 GMT -5
It has been my hope that Sanofi has been conducting a non-FDA study all this time to prove it. Al Mann was adamant about these benefits related to early diabetes therapy. But I/we have absolutely no information whatsoever what Sanofi has been planning in this regard. I still hold a faint hope that Sanofi/MannKind will stun everybody. It could be that strategic moves are still being made by some kind of chess master, but it seems less likely by the month.
I've shared my thoughts on this topic with Sanofi's Pascale Witz via email, but I've not received any sort of reply. The silence is deafening.
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Post by factspls88 on Dec 27, 2015 18:37:35 GMT -5
"Hmmm....of course these Type 2s may never then get to the point where they need a basal insulin as well as a prandial... suebeee1
Re the above: I am saying Sanofi might want to forestall doing the tests to prove that Afrezza is capable of this and make it a key selling point until Toujeo gets a foothold and the decline in Lantus is stemmed. As of now Afrezza does not directly compete with Lantus or Toujeo given that it is a prandial insulin, but IF Afrezza can eliminate the need for a basal down the road then in effect Afrezza will compete with basals by taking potential users out of the market. Quite a good thing in my opinion, but I suspect this is something management at Sanofi may be thinking about. Anyway, it's all speculation on my part. Stay tuned.
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Post by mssciguy on Dec 27, 2015 18:46:40 GMT -5
"Hmmm....of course these Type 2s may never then get to the point where they need a basal insulin as well as a prandial... suebeee1 Re the above: I am saying Sanofi might want to forestall doing the tests to prove that Afrezza is capable of this and make it a key selling point until Toujeo gets a foothold and the decline in Lantus is stemmed. As of now Afrezza does not directly compete with Lantus or Toujeo given that it is a prandial insulin, but IF Afrezza can eliminate the need for a basal down the road then in effect Afrezza will compete with basals by taking potential users out of the market. Quite a good thing in my opinion, but I suspect this is something management at Sanofi may be thinking about. Anyway, it's all speculation on my part. Stay tuned. Dr. Brandicourt couldn't possibly be so cold-blooded... But you never know, if for example, you have BOD members from tobacco or fast food companies, they might put profits before people. But that doesn't seem to be the case: en.sanofi.com/investors/corporate_governance/board_directors/board_directors.aspx=========== mnholdem Jan. 5th +/- a few days we get some answers, right? The new CEO seems perfect. |
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