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Post by compound26 on Jan 5, 2016 19:07:35 GMT -5
To have his first public exposure in such a negative situation and no time to prepare meaningful comments other than cheerleading would be a bad start. While MNKD could not have definitive info of the deal drop for legal reasons, I am sure mgt knew things were going to go badly. I look forward to a message from Duane in the next week to ten days to announce something meaningful. For those referring to being locked in until July, I think that is the required latest date all can end. SNY is still on the hook for expenses until the divorce is finalized. That could theoretically be much sooner. I am sure Duane is in talks with SNY to be freed asap. I am also thinking that Al & Duane may be in (or are considering) a position to settle with SNY on some concessions (some debt or cost sharing forgiveness) in return for a promise not to pile on and sue SNY for lack of promotional / sales effort... seems close that a potential case can be made, and SNY is gaining a reputation. Possible. Pfizer gives Nektar $135M for Exubera settlement November 13, 2007 www.fiercebiotech.com/story/pfizer-gives-nektar-135m-exubera-settlement/2007-11-13Nektar Therapeutics got a consolation prize of $135 million from Pfizer--and a fresh shot at signing a new partner--to calm any upset feelings about Pfizer's abandonment of Exubera, a once mighty prospect in the world of inhalable diabetes therapies. In return, both parties are absolved of any further obligations for Exubera or the next-generation version of the therapy that Nektar has in Phase I. And if Nektar lines up a new partner, Pfizer has agreed to hand over any rights it has in the two products. |
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Post by compound26 on Jan 5, 2016 18:30:08 GMT -5
Could it be that the main reason that Sanofi has no interest in marketing Afrezza because Afrezza reduces the use of basal? The reduction of the use of basal probably was not that widely noted in the trials. However, in the real world, many people started to notice that. So at that point, Sanofi clearly saw conflict of interest and decided to drop Afrezza. www.afrezzajustbreathe.com/afrezza-reduced-basal-insulin-need/ |
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Post by compound26 on Jan 5, 2016 15:15:39 GMT -5
To me apparently Sanofi did not use reasonable efforts to promote Afrezza. Sanofi terminated the license agreement 11 months after a very soft launch. Pfizer pulled off Exubera after 16 months into launch and after Exubera has already obtained approval from both US and EU. Pfizer also spent $370 million promoting Exubera in 2007, including TV ads. Here is another user's comment on this: Jim2 www.tudiabetes.org/forum/t/sanofi-ending-its-afrezza-partnership-with-mannkind/50253/6?u=charles5I had never heard of it until I got my CGM a couple of months ago and returned to this board after a hiatus of several years. I have since gotten some samples and a prescription, and it really is a different animal from injectable insulin that holds great promise. My fear is that it will be viewed as a failure like Exubera and no company will be willing to pick up the ball and take a chance with it. Unfortunately, just having a great medication doesn't mean much if you don't have the means to manufacture, distribute and promote it and survive a sea of red ink until it gains traction. |
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Post by compound26 on Jan 4, 2016 13:47:13 GMT -5
jeesh Compound, that was quick posting, The Pony Express must be on Afrezza........haha Just happens to see your tweet.  This is another message from Sanofi that it is taking a long term approach to Afrezza and it will not give up on Afrezza in the foreseeable future. |
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Post by compound26 on Jan 4, 2016 13:40:30 GMT -5
Afrezza® Product Training Webinar
Afrezza®: A Guide For Healthcare Professionals
Webinar Objectives:
Learn how to use Afrezza® with different patient types
Receive step-by-step instructions on how patients should use Afrezza®
Get detailed dosing information and instruction
Introduction to the Afrezza® Savings Card
Discover how to enroll your patients in the Afrezza® COACH support program
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Post by compound26 on Jan 4, 2016 11:48:23 GMT -5
As I had worried it looks like the formulary numbers worsened slightly with the new year. According to formularylookup.com 3% went from "covered" to "restricted" (assuming this isn't another glitch, but we had anecdotal reports this was happening). At least that isn't a big number. On that news I may actually be buying a bit more. Seems like there is a confluence of negative news now, with possibility we start turning positive from here. DBC, there is also evidence that in certain instances, even though the formulary placement did not change, the prior authorization requirement for Afrezza has been removed. In other words, the formulary tracker does not reveal all the improvements in insurance coverage. Perhaps it is easier for Sanofi to persuade the insurance company to remove the PA requirement than to persuade the latter to move Afrezza to tier 2? If that is the case, hope more and more plans will follow suit and remove the PA requirement for Afrezza. mnkd.proboards.com/post/54332mnkd.proboards.com/post/54327mnkd.proboards.com/post/54306 |
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Post by compound26 on Jan 3, 2016 16:59:36 GMT -5
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Post by compound26 on Jan 3, 2016 10:45:59 GMT -5
www.tudiabetes.org/forum/t/how-do-you-handle-high-post-prandial-readings/50061/45?u=charles5M_K_Type 1 Hello! I love my healthy breakfast: instant oatmeal (20g) mixed with greek yogurt (9g) and 1/2 banana (15g) with cinnamon = around 40-44g CHO. I wake up at 100 (7am), two hours after my breakfast I am at 250 (10am). But at lunch time (12pm), I am back at 120. I was not aware of that spike until I wore a CGM for a week and noticed that. How do you handle that? If I take more insulin, I will have a low at noon... Should I change what I eat or should I talk to my doctor to change to a more fast acting insulin? I'm type 1, use Novolog and Levemir (Basal). Gus1 Short answer: I mostly don't have any of those anymore, since I started using Afrezza back in April 2015. I eat what I want when I want it, and have mostly non-diabetic T1D numbers (A1C of 5.5, ~90% in range 60-140) and life. Long answer: Before Afrezza I did all the heroic and incredibly complex things described in this thread, because there was no other choice. I used a pump. I did a very low carb diet during the day, as carbs where my enemy. I only took a moderately large amounts of carbs immediately after training (run, bike or swim). And I tried to keep my life as monotonous as possible, because change was my enemy as well. So, specifically for breakfast, I only had one with carbs on Saturday as I had time to deal with the IOB mess later. It required planning, pre bolus, waiting, eating, and then based on what happened during those long 4 IOB hours, correct as needed. With Afrezza, this is what breakfast looked like today: I woke up with around 110 (although pre eating sugar does not matter, I just have more Afrezza). I prepared my granola with milk and banana (probably around 100gch, carbo loading for the mid-morning swim :smile: ) . Had my mid size Afrezza dose (its the 8U cartridge, but Afrezza units have nothing to do with injected insulin). And started eating. My BG stayed mostly flat for around 90min. Then Afrezza is gone, and because I eat complex carbs I either give a small dose of follow up Afrezza (4U), or exercise to burn the remaining glucose. That's it. No IOB mess, no severe lows. Really freaking amazing if you ask me. PS: I ditched the pump 3 weeks after starting with Afrezza, as I discovered in awe that most of the super custom basals I was using where to compensate the IOB mess. Now I use Toujeo, once a day. Pump free! M_K_Type 1 Okay, you just turned my world upside down. lol --- Thank you so much for sharing, I am researching right now about MDI, Afrezza, Toujeou... I don't know what any of those things are, so thank you for introducing me to new options that could be a possibility. I am not an athlete like you, but I identified myself with a lot of the things you described. I am writing it down to talk to my endo on my next appt. Thank you!!!
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Post by compound26 on Dec 30, 2015 17:07:10 GMT -5
No, this is not an Afrezza commercial being run on TV. This is someone putting the video on Afrezza.com into Youtube. It's been there for a while. See: www.youtube.com/channel/UCylbMp5M3Ybt_GcavDQzArAYou can find the video under the folder: Afrezza: meet afrezza. |
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Post by compound26 on Dec 30, 2015 10:41:14 GMT -5
It appears the above linked document is only for medicare. However, it appears Aetna has many plans. I am quoting my previous post in another thread below: I did search the three-tier and four-tier formulary for AetnaPremier for both 2015 (updated as of August 1, 2015) and 2016 (updated as of December 1, 2015), it does appear that on those plans, while Afrezza is still in tier 3 for 2016, the PA requirement has been removed. Assuming that is the case, this is still a huge improvement as I understand the PA requirement has been a huge hurdle for a lot of patients. This is especially the case considering that the Sanofi saving card actually cuts the costs for Afrezza users much further. mnkd.proboards.com/post/54306/threadI agree that removal of PA is positive, as is removal of Step Therapy, which has happened in some plans. When it comes down to it, brand name drugs priced at a premium will never be Tier 1, which is for the least expensive generics. Tier 2 (of 3 or 4 tiers) is difficult as well, given that it is for generics or preferred brand name drugs. Tier 3 or below is for non-preferred brand name drugs. See page 9: www.aetnamedicare.com/documents/group/2016/formularies/Aetna_Group_Open1_Enhanced.pdfWhat makes a brand name drug "preferred"? According to Express Scripts: As long as Afrezza costs 2X that of SC insulin, I think Tier 2 will be a tough nut to crack. I did a search for 2015 Comprehensive Formulary Aetna Medicare (List of Covered Drugs), see the link below. And it appears Afrezza was not listed there. Therefore, it is an improvement in that for at least for certain Aetna medicare plans (not sure whether the formulary I searched covers all medicare plans carried by Aetna), Afrezza was not covered in 2015, but becomes covered in 2016. And for the 2016 coverage, the only notation I saw is MO (mail-order). There is no PA (Prior Authorization) or QL (Quantity Limit) marked with respect to Afrezza. dreamboatcruise I recall DBC has been looking for some plan level evidence that Afrezza coverage for 2016 improved vs coverage for 2015. It does appear to me that for certain Aetna plans we just looked at, the coverage is improving (for some plans, PA requirement was removed and for some other plans, Afrezza went from "not covered" to "covered" and without a PA requirement attached). www.aetnamedicare.com/documents/individual/2015/formularies/15045e-aet-standard-formulary-2gap-2015.pdf |
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Post by compound26 on Dec 30, 2015 9:38:14 GMT -5
That's a 2-tier formulary. Tier 2 is the lowest tier. Tier One: You pay the lowest cost for drugs in this level. Your plan may include an additional benefit where some Tier 1 drugs would be provided at an even lower cost to you. These are considered Value Drugs/Tier 1a and include generics and some over-the-counter brand and generic products. These would be available at the lowest cost share indicatedin your plan materials. Tier Two: You pay a slightly higher cost for drugs in this level. Still, at least it isn't excluded. The 2-tier plan is more expensive as well. Even more detail is given in: (page 62) www.aetnamedicare.com/documents/group/2016/formularies/Aetna_Group_Open1_Enhanced.pdfAetna has 2, 3, 4, & 5 tier plans: 2-Tier plan - Afrezza is Tier 2 3-Tier Plan - Afrezza is Tier 3 4-Tier plan - Afrzza is tier 4 3-Tier plus Specialty (4th tier) plan - Afrezza is Tier 3 4-Tier plus Specialty (5th tier) plan - Afrezza is Tier 4 It appears the above linked document is only for medicare. However, it appears Aetna has many plans. I am quoting my previous post in another thread below: I did search the three-tier and four-tier formulary for AetnaPremier for both 2015 (updated as of August 1, 2015) and 2016 (updated as of December 1, 2015), it does appear that on those plans, while Afrezza is still in tier 3 for 2016, the PA requirement has been removed. Assuming that is the case, this is still a huge improvement as I understand the PA requirement has been a huge hurdle for a lot of patients. This is especially the case considering that the Sanofi saving card actually cuts the costs for Afrezza users much further. mnkd.proboards.com/post/54306/thread |
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Post by compound26 on Dec 29, 2015 15:48:16 GMT -5
I love how he says, "If Medtronics still only had 75 people, we'd kick their ass..."
---
This July 2014 podcast, in my opinion, will help you understand why Duane DeSisto was hired.
Nice podcast. I like a CEO that wants to "Kick Ass" and doesn't mind letting people know. I imagine SNY already has been told.  Agree, He is a fighter and that's what we needed. See what he says about the competitors spreading misleading information (or FUD) about Insulet and its products below. Apparently, the shorting of Mannkind stock is not simply driven by profit. Duane DeSisto on competing against corporate giants: www.massdevice.com/podcast-medtech-legends-and-leaders-state-medical-device-innovation/"If you look at the kind of technology they had they really didn’t innovate all that much. What they did is they had a product, they had a need…When we came in if you look at a traditional insulin pump you couldn’t help but scratch your head and say with all the stuff that’s going on ‘there’s got to be a better way of doing this’ and so we went through this process. We created a products disposable, wears around your body, it’s completely discrete for diabetes patients and I think we have two real big advantages. Obviously, they have more resources. We were completely and totally focused. In the time I’ve been Insulet now, 13 years, I’m on my now fifth CEO with [Medtronic’s] diabetes division so we got to be doing something right but it’s a weigh station at a lot of these big companies. As big as this space is I think the advantage all small companies have with an incredible amount of focus, you’re hell of a lot more efficient then. We were able to create something that they really … they couldn’t even dream of it. I mean they spent a lot of time telling the world we were going to fail, they went out. We have five salespeople so they went out to the rest of the country, told people this was a size of a cantaloupe that you’re going to put on your body and it was all the typical stuff that a big company can do because they have resources. They just kept pounding away and pounding away and pounding away.
But we stayed on it. We were persistent about it. We created a product that we believe is by far best in the class and today we’re pushing $300 million in revenue." |
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Post by compound26 on Dec 27, 2015 13:34:19 GMT -5
update from the same member on tudiabetes.org: www.tudiabetes.org/forum/t/insurance-company-denied-afrezza/49313/3We have mentioned the hypos and can prove them on the download of the meter. We will pay out of pocket, and I know they have a $150 knocked off the script but is that a one time thing only? I also know their discount is in effect only until next year. We are not new at this and have been at this for ten years. We have successfully appealed for Apidra, had continual appeals for sufficient testing strips, appealed for Dexcom successfully twice (now she won't wear it). We have one more appeal after this one. Problem is the endo who prescribed the scripts seems to have a very busy practice. We have switched endos before who have refused to fight for adequate strips. I hope the endo will follow through with us to the end of the appeal process. Her receptionist told us we can't appeal as the insurance is demanding visual impairment as one of their grounds. Naturally the endo cannot lie. Hoping for the best, and it won't end here. We will appeal at a governmental or State Insurance Board, whatever we can think of we will do. Once Sanofi stops the discount this could get very expensive. She seems to be using quite a bit of Afrezza... the dosing is not equivalent. But, no, not going back to Novolog, Humalog or Apidra. Been there. Done that. There is no comparison.
www.tudiabetes.org/forum/t/insurance-company-denied-afrezza/49313/8There is a second appeal. We know from past experience that they often will deny the claim and even the first appeal Then you go back with documentation and we did get her Dexcom on the second appeal. We also got her Apidra approved I think on the first appeal. We have had to fight for adequate testing strips countless times. For the next year we are okay because, although expensive, we can cut back elsewhere. She just picked up her first month's script (and she may need more, I'm not sure yet). Sanofi takes $150 off each box I think. She got two boxes of the 8 unit cartridge and one box of the four unit cartridge for $350. I think it may be even less expensive at Costco or Sams; we used Rite Aid. After next year if they don't renew the discount, it would cost upwards of $700. I think she will need another box of the 4 units per month at least. Diabetics and their parents friends, in fact most people with health issues should start a movement, much like Act Up, to get their medical needs covered. We know the drill. I think we will win in the end on the second appeal. Or time to go job hunting for better insurance coverage. That's one way. update from the same member on tudiabetes.org: www.tudiabetes.org/forum/t/what-do-you-think-about-afrezza/47626/77?u=charles5We are not covered by insurance yet and our DD has not been using it long, but I would literally take food off the table to pay for this insulin. And if insurance does not kick in, it may be rice and beans for the adults, LOL. However, she is using quite a bit more Afrezza than she would have used Apidra. 30 grams and under she uses a 4 unit cartridge, 40 and over 8 units. We are giving it ten to fifteen minutes into a meal, and I am beginning to think our timing is off and we should give it immediately after. Regardless of the meal, almost always she will be 170 one hour after eating and we then give a four unit cartridge. It seems to require two doses, either four and four or eight and four, depending on size of meal. Very surprised that at 200 and even 170 one four unit cartridge for correction is not too much, but she is also on a new basal insulin and we are trouble-shooting that as well. For now, the four unit does work for a blood sugar of 170. To give you an idea of the dosing, a correction dose for 170 on Apidra is 1:70 or just one unit. We are probably going to need more than what they initially give for one month. But it is fast, very fast. It is easy to use. She loves it. |
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Post by compound26 on Dec 22, 2015 19:15:28 GMT -5
Pediatric the ideal?. Clearly Afrezza is perfect for kids, but it is perfect for everyone else too. I have no clue as to why Sanofi would want to market this primarily to children. I think Afrezza is good and great for every diabetic that needs (or should use) meal time insulin. It just appears to me that the pediatric markets may be more accessible (once the pediatric trial is completed, of course) compared with the adult market giving that kids are more prone to like/try out new/cool things. |
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Post by compound26 on Dec 22, 2015 17:17:03 GMT -5
About the kids. They do not need a second dose. They take the 8 or 12 after they start the meal and only if they are at a fancy restaurant where the meal lasts a long time and then they have dessert at the end do they use a second dose. Maybe a 4 unit. Using the 8 or 12 depends on the amount of carbs in the meal. So one higher dose works the best for them. I would think that because of the unique PK/PD this is the most logical way of taking Afrezza. Sadly most 'experts' will have a lot of difficulty figuring this out. They play it 'safe' and take to little and to early. Then they need more later. Kids learn faster!
They probably will figure out the optimal timing and dosage of Afrezza in a few days and hence see great results from Afrezza in a few days whereas many adults/experts will try once and twice (based on their existing habits on RAAs) and then claim it doesn't work well for them. See the results the kids are having: www.13abc.com/home/headlines/Inhaled-Insulin-now-helping-diabetics-362524351.htmlIf the above assumption is true, it appears it would be a great idea for Sanofi to prove superiority of Afrezza via a pediatric trial. Now considering that all the participants in the pediatric trial must have a CGM, maybe there is something to that effect in the trial design.Even if the current ongoing pediatric trial maybe too small (46 participants) as a superiority/label improvement study, it appears the data Sanofi collects from such study will greatly help Sanofi design the actual superiority/label improvement study. See some of the unsuccessful trails of Afrezza made by some of the experts (including Endos) on Afrezza: www.healthline.com/diabetesmine/afrezza-focus-group-feedbackMatt. B would be an ideal Endo to spread the words of Afrezza to patients. He's doing many tests/experiments on timing and dosing on different type of foods/situations. That is the thing Afrezza uers should do. Plus, I would think most kids hate injections (more than adults do) and kids generally love to try out and be linked to new/novel things (which Afrezza is).
For the above reasons, will the pediatric diabetic markets be the best/ideal markets for Afrezza?
Maybe. I think that will be the case once the pediatric trial is done, especially with some kind of superiority label attached to Afrezza by then. |
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