Sanofi ending its Afrezza partnership with Mannkind

Treatment Insulin
41

An fev1 spirometry is all that’s recommended-- it literally takes 1 second (that’s what the 1 means) and can be done on a handheld device that costs next to nothing. We literally did them in health class when I was in high school. I’m pretty sure it’s not an insurmountable obstacle to figure out. Any medical assistant can very easily administer this test with less than 5 minutes of training, and most primary care offices in the country are equipped to perform them… The hype and hysteria over dreaded lung tests was infinitely more obstacle than the tests themselves. It is not uncommon for fev1 to be measured during routine primary care physicals… It is really not a big deal-- though in this age of Internet sensationalism it was made to seem like a much bigger deal than it really was.

Though some doctors (including mine) had patients do a full pulmonary function test which is kind of a costly pain in the butt, and unnecessary— if my doc asked me to do it again I’d just tell them I only want to do the fev1 in the clinic…

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Advair and Symbicort (and any similar ones I don’t know of) are available in powdered form or a non-powdered form. But both of these medications also have big bold warnings on them saying that they increase the risk of asthma-related deaths compared to other medications… I don’t know if that’s due to the powder or something else, but I think that even if the powder did cause irritation, these medications in and of themselves open the airways anyway.

I’m not saying that Afrezza isn’t great, just that I truly don’t think it’s the end-all of insulin. I truly hope that an ultra rapid-acting injectable insulin is developed in addition to this option. More options are always better, so I do hope that Afrezza is successful…just not at the expense of other options.

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@Jen I hope so too, and I hope that they’re developed by big pharma instead of a small company so that you will ever actually hear about them and they’ll be given credibility when it happens.

Besides there is so much more to how well this works than just how fast it is… Can you even imagine having flat blood sugars regardless of what you eat (if you eat reasonably healthy balanced meals) without hypos, without carb counting, pretty much without trying? Living pretty much a normal life again like everyone else and not worrying about your blood sugar? A year ago I couldn’t have imagined that— now it’s my reality again almost just like before diabetes (except I actually have to eat right now). There’s a lot more going on here than just speed. I don’t claim to understand it all, but I can’t imagine living with diabetes without it.

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44

I am not sure if she’d have pushed it, I’d have been really receptive to that. It’s mostly having to get the lung test done and then go back for another appointment. And they offered to squeeze the test into an appointment but the problem was mostly me. I have may weird insulin habits pregaming,temp boluses,IV shots, etc. that I don’t have a huge need for something that works really fast to eat whatever. I haven’t had a problem or catastrophic hypo for several years. The pump is as convenient as an Afrezza one-hitter (four hitter? LOL…) I think?

45

There’s obviously a great deal of misunderstanding about this lung test. I blew into a simple plastic device three times, and that was it. Many providers clearly haven’t received solid education on the product. I guess we can pin that on Sanofi, or perhaps disinterest.

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46

I know that’s what the test is. I had it before once when I’d had a lengthy spell of bronchitis. It’s not the test itself, it’s my own why bother attitude. The provider understood what it could do, just not that I have any particular need for what it does.

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No, I can’t. I can’t remember life before diabetes, so I have nothing to compare to in regards to “just like before”. The way people have described Afrezza working sounds almost like the smart insulin that was being developed at one point (or maybe is still being developed, though I haven’t heard anything about it lately).

48

OK, @acidrock23 . Didn’t mean to insult your intelligence, but when you mentioned having to “squeeze it in” to an appointment or have it done at another appointment, I assumed they were referring to much more involved testing that some providers seem to believe is necessary. Obviously, it’s not for everybody, and if it was your decision rather than the provider’s, then that’s the way things should be handled.

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It works a lot like smart insulin too, and yet the people’s lives who can benefit so tremendously from it aren’t even interested. I just don’t understand how we got here. Shame on us, we are the problem-- and our attitudes, as a whole, will surely stifle further breakthrough innovations in this field.

At this point I honestly I think someone could invent a perfectly safe and effective CURE and we’d just sit here and turn up our nose at it.

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50

I suspect you would find convenience factor completely incomparable after you actually tried it…

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51

Again, how long has Afrezza been out? Less than a year? I’m pretty sure that no insulin was widely adopted a year after its release.

52

Sam, I share your frustrations, but I do think we need to be a bit sensitive to the nature of a diabetic altering treatment, especially when it comes to a new insulin like Afrezza.

While we agree that the marketing of Afrezza by Sanofi was essentially nil (this comment by Sanofi’s rep was laughable, "Sanofi spokeswoman Susan Brooks said the company didn’t scrimp on promoting Afrezza.") I think an often not talked about or considered barrier to entry is the fact that diabetics tend to be stubborn to change when things are going well. Kind of the “if it ain’t broke, don’t fix it” attitude. Personally, I don’t fall into this category because I’m always looking for the latest and greatest, but I certainly understand this line taken by many diabetics.

I imagine this thought in many a T1’s heads … “I’ve worked hard to get my blood sugars stable and comfortable using (insert treatment plan here . . . pump, MDI, humalog, lantus etc etc). Why go through the hassle of changing that plan that I’ve worked so hard to tweak over and over to try another insulin? Especially one that requires a lung test.”

Sometimes folks are hesitant to try something new and sometimes they just don’t want to go through the grind of all the nuances, tweaks and tests when things are going well. For me, the Spirometry test was a piece of cake and just another appointment, but for others it just adds to the burnout and never stop nature of treating T1.

I get all of this . . . but to Sam’s point, we need to push forward and continue to advance the treatment of T1 diabetes (T2 as well) until we have cure. Undoubtedly, for those using Afrezza on a consistent basis, this is the biggest advance we’ve experienced since being dx’d and it’s a shame it could go away because to us, we would be stepping back instead of continuing progress towards the future.

Again, let me be clear, I am NOT criticizing my fellow T1’s who choose not to try or use Afrezza. Every one of us is unique and our treatment decisions are our own and nobody respects that more than me. I am not pushing Afrezza in any way, just simply trying to convey that this drug is a HUGE leap forward and I think sometimes that can be hard to understand.

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[quote=“Jen, post:51, topic:50253, full:true”]
Again, how long has Afrezza been out? Less than a year? I’m pretty sure that no insulin was widely adopted a year after its release.
[/quote]Because you have asked a number of times and not gotten an answer I thought I’d drop one in for you. It was June 27, 2014 when it was approved:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm403122.htm

As is the way of the DOC, the OP is gone astray. Seems to me that the users of the product are the all knowing and probably the best marketers of this product. It is interesting to not see much ad space not only in the forums and the docs offices but at the trade shows and such. Mannkind will need to find a partner to keep this product available and it’s not going to be easy. Shares of the company are tumbled 27% in midday trading after the announcement and over the past three months, shares have dropped 67%.

Not Good. Like Jen, I am glad there will still be some injected insulin available, I also can’t use the inhaled stuffs.

54

Having spoken at the Advisory Committee meeting where Afrezza was discussed, and ultimately recommended for approval by the agency (which eventually happened):
http://diabeteshandsfoundation.org/afrezza-fda/
I am truly saddened to see this happen.

I hope this does not spell the end for Afrezza, but it’s going to be a VERY challenging road ahead for MannKind to (continue to) bring Afrezza to people with diabetes.

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Sanofi’s ‘conflicted’ handling of Afrezza stunted inhaled insulin R&D, says Dance CEO

Despite Sanofi’s “conflicted” management and subsequent abandonment of Afrezza, the market opportunity for inhaled insulin is still huge, according to Dance Biopharm’s CEO.

This week, Sanofi abandoned its commercialisation deal for the inhaled insulin product Afrezza, leaving developer MannKind Corporation looking for a new distribution and licensing partner.

The news is the latest blow to the inhaled insulin sector which was left unsettled following the failure of Exubera in 2007. A lack of acceptance by patients and physicians led Pfizer to pull its product a year after launch and at a cost of $2.8bn, and within a matter of months fellow Big Pharma firms Eli Lilly and Novo Nordisk abandoned their own development projects.

Despite this background, Dance Biopharm’s CEO John Patton said there is still a market for inhaled insulin, though Sanofi’s actions have marred his own company’s efforts in developing Dance-501, a pocket-sized inhaler device and insulin container designed to deliver prandial insulin.

“The less-than-optimal performance of Sanofi with Afrezza has had an impact on our development, because investors have become more sceptical about inhaled insulin, so raising money has been difficult and that has slowed our development effort.” he told in-Pharmatechnologist.com. “This particular news is not helping!”

He continued, blaming both Exubera and Afrezza’s problems primarily on a lack of persistence and commitment by their marketers.

“Exubera never had a chance, and Afrezza may have been priced too high and was targeted to a very small percentage of the insulin users.”

Conflict of interest

Sanofi is looking to reinvigorate growth in its diabetes franchise through its marketed products Lantus and Toujeo, and Patton said this left the French Pharma Giant “conflicted” when it came to Afrezza.

“Inhaled insulin can directly compete with Lantus and Toujeo in Type 2 patients, and with all of the prandial insulins in both Type 1 and 2 they were conflicted. No way Sanofi was going to go against its golden goose franchise.”

Last February, Dance raised $9.5m in private funding to prepare for further clinical trials of Dance-501. The product is a soft mist made by a little electronic device which has completed Phase II trials and, according to the firm, has an action not quite as fast as Afrezza but lasts longer than MannKind’s product.

“Inhaled insulin will be enormously successful someday,” Patton said. “We believe our soft mist product will lead the way.”

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Soft mist sounds good, but slower AND longer-acting than Afrezza? I think we already have that. Certainly not peaking my interest. FASTER, SHORTER are key…

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It won’t matter if they invent the cure itself if the majority of diabetic community is too hard headed and close minded to actually use it.

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58

I wish they could put it on Dr. OZ. Would love to see him walking through how it works differently from other insulins how fast it is in and out, the drop management time, the lower risks of a hypo, and how to use the inhaler. Then have a few users on like Sam, Mike, and Jim for testimonials. He’s got a huge following. I think you’d see an immediate uptick in scripts and give life to this great drug. It would certainly be 100x the Marketing exposure that Sanofi has done.

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I believe Sanofi had no intention of promoting Afrezza. Sanofi basically sat on the drug until they were able to market their new injectable… the name of it escapes me at the moment. Remember how excited everyone was when Merck bought SmartInsulin from Dr. Zion. It was ready for large animal studies. Merck shelved it. Why? They had no insulin of any kind to sell. But they did have Januvia. And certainly were not interested in a cure while they could milk the huge Type 2 market. They are working on SmartInsulin now (under another name) but only because there is another company working on a Smart Insulin of their own. It’s all about the money. And they have made their $50 thou a year off my daughter for the past ten years. Sanofi is being sued by another company for failing to keep up their part of the bargain re marketing and promotion. Slow roll out? It was a NO Roll out.

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Even those willing to try have to locate a doctor who will prescribe it. Then the doctor has to be willing to help fight the insurance company so you don’t have to pay out of pocket. Which we are and which we will. But without the half price card, this is going to cost $1,000 plus a month. Pretty steep for most people. Sanofi or Mannkind needed to push this into Tier 2 approval, needed to find endos willing to prescribe it. Needed to advertise it. And, yes, alleviate the legitimate fears of people who think they are going to get lung cancer. Alleviate the fears of people afraid to take the lung spirometry test (it’s just breathing hard, folks). And I believe the warning labels need to be clarified. But I do find the close mindedness of this community mind-boggling. And I say this because I responded to your first post when you were in clinical trials. People would not even give you the courtesy of listening. I also think people are afraid of the dosing. It’s hard to wrap your mind around the fact that a teen who drops 70 points on one unit of injected insulin drops 90 points on 4 units of Afrezza. Which won’t be true for everyone. Maybe some will only be able to use Afrezza for meals or very high blood sugars. You have done more than anyone to educate people and I thank you. I hope Afrezza makes it.

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