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Post by stevil on Dec 9, 2015 13:08:37 GMT -5
Truth be told, Afrezza is as good as it gets, scientifically speaking, unless it proves to cause cancer or has other unknown side effects- which it shouldn't.
As far as PK goes, nothing will ever be able to improve. You can't get any better than natural insulin acting exactly as the pancreas does. As Al said in his video, he couldn't even squeeze a piece of paper between the PK profile of Afrezza and the pancreas. They're identical.
The only way anyone can improve on insulin is if they find a way to automate it so that people don't have to think about administering it. Short of stem cells/some other mechanism healing a defective pancreas, this is as good as it can get chemically.
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Post by esstan2001 on Dec 9, 2015 13:17:59 GMT -5
Scotta, excellent post.
Regarding Dexcom and SNY-Google partnership, my best guess.. early '16 they have some decent prototypes they are demonstrating... mid '16 they can start delivering product- early '17 there is a viable / sale-able database that ins Co's can procure and make decisions on. Hopefully the timeline can be pulled in a quarter, but this may be why SNY has dragged their arse on the superiority trials, thinking they will become less important with the data available, and probably why MAtt / Hakan never got too alarmist regarding their partner's efforts.
Meantime, how do we make it to that point in time.... Al... whoever?
Gotta get another TS deal or 2 in place.
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Post by cathode on Dec 9, 2015 13:21:09 GMT -5
I am confused about what you mean. Verily (Google Life Sciences) would work with SNY on understanding how people respond to dosing so that Verily(?) can build a non-attached CGM? What do you mean by non-attached? Like the Novartis contact lens? How does SNY/Afrezza data help the engineers at Verily achieve this? I am buying the bigger connection between SNY/DXCM/GOOG, but don't really understand your specific speculations. Thanks. What he means is that Google (AKA Verily) has a partnership with Dexcom. Dexcom's newest sensor, the G5 sends glucose readings directly from the patient to a smartphone (previous Dexcom sensors sent the info to a Dexcom device to record the data - this is what Sam currently has as seen in his twitter posts). What the Google / Dexcom relationship is for is to develop a smaller less expensive bandage like sensor with a significantly lower price point. This new sensor which is still being developed will be sold into retail pharmacy channels. Dexcom will build the sensor and apparently, Google will help with the engineering. Here is a link: www.digitaltrends.com/android/google-dexcom-glucose-monitor/Google wants to own the data which they will be able to sell to health insurance companies, clinics / doctors / IDN's (so the providers can demonstrate that pools of patients are improving their glucose control, health, etc) and then the provider can get part of their reimbursement in the form of outcomes based vs fee for service which is where things are heading. Google's cut of the revenue does not start until nearly $1B and it is going to make a fortune. By the way, the folks at Dexcom apparently have some other toys in the box that measure more than just glucose so while diabetes is a massive market, for Google, it is the entry point. Why would Sanofi want in on all of this, well in short, MONEY. If they are smart, they bundle Afrezza with Lantus, Toujeo and in the future, a better basal and they will show via Google data that patients on the Sanofi combo of meds have better control, better health and reduced long term health complications. Based on where this is all heading, Sanofi would be foolish to let Afrezza and Mannkind fail. There is no other prandial insulin that is remotely close to performing as well as Afrezza. Another thing, Afrezza will significantly and adversely impact the pump market (kind of ironic right). Pumps had their day but they cost a lot, require a new infusion set every 3-4 days, patient has to constantly fiddle with the pump to adjust infusion rate, bolus, etc and the pump along with 42" of tubing hangs on a belt, stuffed in a bra yadda yadda. Pump replaced every 4-5 years at a cost of around $7,000 (remember plus 2 infusion sets / week at $15 - $20 each)... Afrezza + daily basal injection is way better, easier, more convenient better outcomes, etc. For the type 2 market, Mannkind can load up to 36 units on a cartridge. Share price sucks and no noise from management. Maybe its over and maybe its not. Either way, Afrezza is head and shoulders above any other product invented for diabetes in terms of controlling blood glucose levels, reducing A1c and maintaining better long term health. Edit: by sending patient glucose readings directly to smartphone, the phone can send it up to the Google cloud and patient can get feedback, good, bad or otherwise. A message to reduce carbs, take insulin 5 min after starting meal are a couple of examples. Artificial intelligence makes it nearly infinite as to what type of patient feedback would result based on glucose levels and other patient data that is constantly fed up to google cloud via sensor patient wears. Also, 3 of Dexcoms top management including Terry Greg and Kevin Sayer worked for Al Mann at Minimed. Thanks for the reply Scotta -- I agree that what you described are potential goals and purposes of the collaborations. What you did not touch on, which was actually what I wanted from sluggobear, was how SNY/Afrezza would help CGM development. |
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Post by Deleted on Dec 9, 2015 13:25:39 GMT -5
What he means is that Google (AKA Verily) has a partnership with Dexcom. Dexcom's newest sensor, the G5 sends glucose readings directly from the patient to a smartphone (previous Dexcom sensors sent the info to a Dexcom device to record the data - this is what Sam currently has as seen in his twitter posts). What the Google / Dexcom relationship is for is to develop a smaller less expensive bandage like sensor with a significantly lower price point. This new sensor which is still being developed will be sold into retail pharmacy channels. Dexcom will build the sensor and apparently, Google will help with the engineering. Here is a link: www.digitaltrends.com/android/google-dexcom-glucose-monitor/Google wants to own the data which they will be able to sell to health insurance companies, clinics / doctors / IDN's (so the providers can demonstrate that pools of patients are improving their glucose control, health, etc) and then the provider can get part of their reimbursement in the form of outcomes based vs fee for service which is where things are heading. Google's cut of the revenue does not start until nearly $1B and it is going to make a fortune. By the way, the folks at Dexcom apparently have some other toys in the box that measure more than just glucose so while diabetes is a massive market, for Google, it is the entry point. Why would Sanofi want in on all of this, well in short, MONEY. If they are smart, they bundle Afrezza with Lantus, Toujeo and in the future, a better basal and they will show via Google data that patients on the Sanofi combo of meds have better control, better health and reduced long term health complications. Based on where this is all heading, Sanofi would be foolish to let Afrezza and Mannkind fail. There is no other prandial insulin that is remotely close to performing as well as Afrezza. Another thing, Afrezza will significantly and adversely impact the pump market (kind of ironic right). Pumps had their day but they cost a lot, require a new infusion set every 3-4 days, patient has to constantly fiddle with the pump to adjust infusion rate, bolus, etc and the pump along with 42" of tubing hangs on a belt, stuffed in a bra yadda yadda. Pump replaced every 4-5 years at a cost of around $7,000 (remember plus 2 infusion sets / week at $15 - $20 each)... Afrezza + daily basal injection is way better, easier, more convenient better outcomes, etc. For the type 2 market, Mannkind can load up to 36 units on a cartridge. Share price sucks and no noise from management. Maybe its over and maybe its not. Either way, Afrezza is head and shoulders above any other product invented for diabetes in terms of controlling blood glucose levels, reducing A1c and maintaining better long term health. Edit: by sending patient glucose readings directly to smartphone, the phone can send it up to the Google cloud and patient can get feedback, good, bad or otherwise. A message to reduce carbs, take insulin 5 min after starting meal are a couple of examples. Artificial intelligence makes it nearly infinite as to what type of patient feedback would result based on glucose levels and other patient data that is constantly fed up to google cloud via sensor patient wears. Also, 3 of Dexcoms top management including Terry Greg and Kevin Sayer worked for Al Mann at Minimed. Thanks for the reply Scotta -- I agree that what you described are potential goals and purposes of the collaborations. What you did not touch on, which was actually what I wanted from sluggobear , was how SNY/Afrezza would help CGM development. Neither Sanofi, Afrezza or Mannkind would help in the actual involvement of the CGM development. Afrezza is simply a tool for Sanofi or another major Rx manufacturer to demonstrate best in world control of blood glucose levels in patients with diabetes. By demonstrating this, the price of Afrezza could be raised and still offer superior clinical outcomes and a better economic value by virtue of reduced visits to ER for incidences of hypos as well as significant reductions in long term health complications (google Diabetes Control and Complications Trial). What does a laser treatment cost for diabetic retinopathy - I don't know but my guess is north of $10k. Think dialysis, chronic wound care, amputation, heart disease and the list goes on. Reduce long term health complications by 65%+ and tripling the price of Afrezza is still chump change compared to the savings. |
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Post by mnholdem on Dec 9, 2015 14:30:22 GMT -5
cathode - When I posted the original post about the convenience of Dexcom being headquarter in San Diego, I was thinking that it was Sanofi/MannKind (Afrezza) that had the most to gain by inviting Dexcom to learn about Afrezza from the first adopters who largely used CGMs. Sanofi could try to show how the new inhalable insulin could showcase the new Dexcom "bandage" CGM by eventually marketing them together as a needle-free solution. So, yes, Dexcom could benefit from the commonality of being needle-free solutions, but Afrezza would benefit more if they were to collaborate in this manner.
Being "cool" is a marketing aspect that will become especially relevant after Afrezza is approved for 4-17 year old diabetics. What would be cooler than a bandage CGM that transmits to your smartphone and using Afrezza for complete needle-free control of your glucose level? Of course, if you are a Type 1, a daily (or eventual weekly) basal injection would still be needed.
Still, "cool" sells to kids. Not having to stick themselves - for either blood testing or insulin - will be considered to be very cool, IMHO.
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Post by sluggobear on Dec 9, 2015 15:03:02 GMT -5
Regarding Dexcom and SNY-Google partnership. There was a conversation with Dtrouble on YMB yesterday about the use a CGM for his girlfriend. (I sure wish I didn't know ALL the Afrezza users and family members by name!) I think his girlfriend is a T1D who happily went off the pump and on to Toujeo and Afrezza. I don't know if he's on Proboards; he posts on Twitter as Stephen Parsons @dtroue1003. My non-PWD observation is that it sounds like a lot of first time users have a settling-in period for dosing. A CGM would probably help a lot for getting new Afrezza users up to snuff on timing their puffs and dialing in their basal insulin, if they take basal. At the Mannkind-Sanofi advisory board meeting in San Diego, I assume discussion about Afrezza timing and dosing was prominent. Google and Sanofi might work together on the vagaries of insulin dosing and BG control, in order to provide insulin-using diabetics with an affordable, non-attached CGM. The future is in providing near normal BG control for PWD's with less cost and a lot more convenience. I am confused about what you mean. Verily (Google Life Sciences) would work with SNY on understanding how people respond to dosing so that Verily(?) can build a non-attached CGM? What do you mean by non-attached? Like the Novartis contact lens? How does SNY/Afrezza data help the engineers at Verily achieve this? I am buying the bigger connection between SNY/DXCM/GOOG, but don't really understand your specific speculations. Thanks. Cathode - sorry for your confusion. I shortened my comments and ended up losing the thread of the highlighted sentence. I tried here to clarify (a little) what I meant by a relationship between SNY (Afrezza) and (Google/Dexcom) in development of a CGM. In product development, the User Requirements are defined early in the design of a device. For additional info: www.kmcsystems.com/blog/bid/103309/How-to-Define-Your-Medical-Device-RequirementsThe "vagaries of insulin dosing and BG control" refers to what I've read about Afrezza user's initial experiences and titration/modification of basal insulin needs. The potential need and usefulness of a CGM by new Afrezza users is something I picked up from reading Afrezza user's experiences. I know a little about the biology of glucose metabolism and hormonal control but it seems there is a lot left to understand. I could see Google Life Sciences and Sanofi working together to better understand diurnal, prandial, and other physiological fluctuations in BG for the development of a novel CGM. Such information might be used to better tailor insulin dosing predictability for Afrezza users and PWD's in general. Not sure I'm clarifying well... By non-attached - yes, the Alcon/Google contact lens maybe but more like the GlySens implanted system (http://glysens.com/products/glysens-icgm/) or Abbott’s FreeStyle Libre Flash Glucose Monitoring System. The sensor bandages which are being developed may include additional functions. We know that being an insulin-requiring diabetic means constant vigilance and that a lackadaisical attitude is life-threatening. Proper BG monitoring, maintenance, and insulin correction of BG levels is a luxury for those with limited means. The ability to avoid some of the tedium and pain of constant finger sticks and injections should be welcome by diabetics, as long as they can afford it. Edit: Thanks to Scotta and mn for the additional commentary and granularity on Dexcom. Getting off the pump apparently made Dtrouble's girlfriend very happy. |
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Post by cathode on Dec 9, 2015 15:19:25 GMT -5
mnholdem, as I said earlier, I completely buy whatever Verily has planned for their diabetes R&D program. I think they collaborated with the companies that have first-rate products in their fields. The engineering and data analysis available at Verily should only boost those products and revolutionize the treatment of diabetes. I am not really buying that SNY needs to show DXCM that Afrezza is fast/efficacious, whatever. They already know that. I don't think Afrezza will be shaping the Verily-DXCM product of the future. From listening to the DXCM conference call about the Google agreement, it seems like the focus is really on engineering a smaller and cheaper CGM. Basically one that is able to penetrate into the T2DM userbase, which DXCM has notoriously had trouble getting into. Of course the T1 patients will also benefit from the lower costs and smaller form factor, etc. As far as the "coolness" factor for kids, until they start paying the medical bills it doesn't matter too much what they think. Less finger pricks and injections definitely sells to parents and schools though.
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Post by mnholdem on Dec 9, 2015 15:41:33 GMT -5
Everything you say is true. I would also add that the motherlode for Afrezza is also the T2DM userbase, which Sanofi estimated in 2014 to be more than 9x larger than Type 1 diabetics. That's something to consider as a motive. Good discussion.
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Post by Deleted on Dec 10, 2015 8:55:33 GMT -5
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Post by Deleted on Dec 10, 2015 9:04:37 GMT -5
wish Dr Edelaman flashed his dreamboat and then if he had a CGM ..show his flat line... Its about time early adopters attend these meetings..so doctors get the social aspect of it |
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Post by Deleted on Dec 10, 2015 9:10:31 GMT -5
Great info, thanks for sharing. For any of you who know and understand the regulatory process, will any of the studies that Sanofi has just completed allow the label to be changed to say "Ultra Rapid Acting" and / or "Reduces incidences of hypoglycemia" and / or "Reduces A1c"? If none of the current studies (assuming the data supports the claim) will allow for these label changes, what kind of studies would allow for this and how long would they take to complete? Ultra Rapid Acting and Reduced Hypoglycemia on the label and we are off the to races. Even if the Spirometery requirement and Prior Authorization issues stayed around. |
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Post by Deleted on Dec 10, 2015 9:11:45 GMT -5
Finally it is official!
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Post by kbrion77 on Dec 10, 2015 9:20:43 GMT -5
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Post by hawaiiguy42 on Dec 10, 2015 9:25:04 GMT -5
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Post by mindovermatter on Dec 10, 2015 9:43:02 GMT -5
If anyone takes the time to read through the slides you'll see it confirms the issues surrounding the resistance to accepting not just insulin but inhaled insulin in the medical community here in the United States. And I clearly understand why Sanofi has taken the approach it has. The calls for wide spread advertising etc would have been a disaster. This is a marathon not a sprint and Sanofi is preceding with care and caution as it always said it would be. |
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