Sanofi ending its Afrezza partnership with Mannkind


#21

Afrezza users also reported that Afrezza will cut (and in some cases eliminate) the use of basal. That to Sanofi means less sales for Lantus and Toujeo, their golden goose.

Here is an Afrezza user on tudiabetes.org says: ““I have been a Type 1 diabetic for 58 years. After 52 years of thousands of injections, I became needle-phobic. The OUCH you think is minor to you is not minor to millions of others.
.Spent 5 1/2 years in a research study trial using AFREZZA inhaled insulin. I have not had to take an insulin injection during those 5 1/2 years. Believe me, I know that is not a cure. But for now it is the best out there for those of us struggling physically and emotionally with injections.””

She gives more information on her experience in another post: “When I first joined the MannKind trial, I was injecting Lantus in the morning at breakfast and inhaling Exubera with each meal. Before Exubera had been taken off the market, I had stockpiled quite a large supply. It could be stored on a shelf at room temperature, no refrigeration was needed.

In the beginning, I still took my Lantus at breakfast and then began using the Technosphere {Afrezza as it is now called} with each meal. My BG levels began to drop. My doctor kept lowering the Lantus until he suggested I drop the injections completely. It took me a couple of days to work up my courage, but the idea of not taking ANY shots was worth it. It worked for a few weeks, and then my BG levels started to rise. Terribly disappointed, I went back on the morning Lantus shots and inhaling at each meal. Shortly, my BG levels dropped again, and** my doctor took me off injections again. From then on, NO SHOTS!!! No one can explain it — it just is**!””


#22

While I hope Afrezza finds a new avenue of distribution, I certainly hope it doesn’t destroy all the markets you mention. It’s great that so many people here find it life-changing, but there are some 435+ million people worldwide with chronic lung diseases who will probably never be able to use an inhaled insulin safely (myself included). That’s more than the 371 million people with diabetes worldwide. Inhaled insulin sounds fantastic, but it can’t and shouldn’t be the end of injected insulin.


#23

Jen, maybe so, or maybe it’s actually perfectly suitable for people like you too and the fact that it was counter indicated for people with those issues is just part of the rest of the industries self defense mechanism to keep it from catching on. Prescribing guidelines can be adjusted over time as a drug is proven safe and suitable. I believe the chief pulmonologist on the fda expert committee was vocal about disagreeing with those guidelines.

The example of you sitting there thinking and saying “this could never benefit me or hundreds of millions of others” is a shining example of how how I think the industry threatened by afrezza have thus far been successful… That thought, that concern, that belief, was taught to you, without you even knowing it— you weren’t born thinking that. The experts who evaluated the safety of afrezza didn’t tell us that—

The fda said that— and I for one think that the fda is largely a puppet of big corporate lobbyists who have an awful lot to lose.

Of course there is a much smaller number of people who probably can’t tolerate it… As there are with any medication, and for those people of course alternatives would always need to be available.


#24

People with asthma and other chronic lung conditions are advised to avoid any irritants (allergens, cigarette smoke, pollution, fumes) and are often on daily medications to keep their lungs open and inflammation down, plus “rescue” inhalers for if symptoms suddenly get worse. I suspect that as long as Afrezza has instances of coughing or other lung symptoms as side effects, it will probably not be deemed safe (it may not even be the insulin, just the mere act of inhaling a powder could trigger asthma symptoms). So, I still don’t think it should be the only option or future, no matter how great it is.


#25

Fair enough, nobody is suggesting that injected insulin needs to disappear off the earth.

Im just saying that for people who have been using it, which thus far only includes people without lung diseases, afrezza works a LOT better than injected insulin, and I believe that the rest of the industry is very threatened by it, understandably so… And they’re also very powerful


#26

I said it would probably never be safe, not that it couldn’t ever be safe. And I wasn’t just “told” about what things could trigger asthma - I’ve experienced it, and have even ended up in emergency struggling to breathe (and my asthma is on the mild-moderate end of the spectrum). Maybe some people would be comfortable taking a medication knowing it could trigger that type of reaction, but many wouldn’t want to.


#27

I’m only referring to afrezza, not to asthma— you inhale medications into your lungs to treat the asthma itself don’t you? Aren’t some inhaled asthma medications in powdered form such as advair?

The chief pulmonologist for the fda expert committee said afrezza was safe for everyone… Then the fda said otherwise— it’s all part of my conspiracy theory

I’m not suggesting that afrezza would actually be suitable for you, I’m suggesting that the reason so many people think that it’s not is a direct result of the market manipulation that I believe to be taking place by big pharma to save themselves from a superior product that completely turn their profits upside down… The warnings that weren’t recommended are just one small part of that and only pertains to a small small portion of the market— a marketing partner who doesn’t market anything is another part that affects much more.


#28

It would be interesting to know what other committees in other countries think, since as far as I know Afrezza has only been approved in the U.S. Presumably contraindications are based on available studies and data, and I would think guidelines would be similar in other counties even though they are not nearly as profit-driven as the U.S.


#29

I hope that time will tell… In my opinion this is the biggest breakthrough in medicine that has occurred in my lifetime— it is crazy to me that the world is just sitting by watching it spiral down the toilet… It’s irrational. It borders on inconceivable, and that’s why I truly believe that there are forces pulling strings to cause this to happen… And I hope those forces can be overcome… If not, it’s a tremendous loss and a sad situation for the entire world.


#30

@Sam19,

You must be pretty young :wink: The shift from NPH and R to modern analog insulins has led to a substantial increase in our life expectancy and has greatly reduced the risk of devastating complications. The development of AIDS cocktail therapies and the polio vaccine were pretty good too.

But I take your point.

Maurie


#31

Polio was significantly before my time and I’ve never known a single person with HIV personally, whereas I know personally dozens of people with diabetes whose lives could be improved tremendously by afrezza.

And I consider the improvement from analogs to afrezza to absolutely drawf the still tremendous improvement from R and NPH to analogs… Although that improvement does add to the efficacy of afrezza as well because basal insulin is still required in most cases…

It was not an exaggerated statement in my belief… Though I can fully appreciate how someone who has never used it might be completely underwhelmed by it…

I, however, as a type 1 diabetic achieving perfectly normal blood sugars while using it and eating a balanced diet with essentially zero additional effort— consider it a tremendous breakthrough.


#32

Interesting news! I talked to my doc about Afrezza. She was supportive but I’ve had decent results lately and was like “meh, why change anything” as it would require appointments and all of that. I have stayed in the pipeline and referred anyone discussing the issue to the threads here as, to me, they are the best source of information about the product. I’ve known many of you folks for years and know that you know what you’re talking about. I don’t have anything to say about Afrezza but wanted to give you a shout out in support of your useful and always interesting support to the community!!


#33

I’m afraid your doctor’s attitude is a huge part of the problem. Yes, great results are achievable with analog insulin, but at what cost in time, convenience and risk of hypos? Afrezza just makes things better and easier for many diabetics, but it’s largely misunderstood and poorly marketed. Overcoming these issues is a huge challenge that, unfortunately, may be impossible to successfully manage.


#34

I would love to try Afrezza but haven’t brought it up with my endo whom I only see twice a year. I truly believe that it would be difficult to convince insurance that I have a real need for it. My A1c’s are good and due to my CGM, I have had no recent lows that need assistance.

I like the idea that in the long run Afrezza could save insurance money if we all quit using pumps. But right now my insurance pays for a pump and supplies, Lantus when needed, a meter and strips, and a CGM and supplies. Unfortunately they are not set up to deal whereby I could promise to quit my pump if Afrezza worked well.

Also, I am a year and 3 months away from Medicare. I am saving my T1 Medicare advocacy for CGM coverage and will leave the Afrezza battle to the rest of you.

But based on the user reports on TuD, I do hope that Afrezza doesn’t disappear.


#35

It all depends on your insurance, many cover it without batting an eye…
I agree with jim that any doctor (and any patient) who just figures they’re having good enough results with analogs that there is no point in trying something tremendously better is completely missing the point… Where would civilization be if they stopped advancing a hundred, a thousand, or maybe a million years ago when the first cavemen learned to sharpen sticks… Where will we be a hundred or a thousand years from now if civilization stops taking advantage of medical breakthroughs because they break through at the expense of established big pharma. I don’t want to find out.

I had a1cs as low as 4.9 with analogs, I know they work. But with afrezza I am not living just the life of a tightly controlled diabetic, I’m actually living. You’re all really missing out if you’re not using it.


#36

A meaningful quote from the original “afrezzauser” Sam Finta on Facebook–

“Great conference call. No interruptions for Afrezza users and Mannkind will announce their plans for Afrezza in the next few weeks. They said about as much as they could on short notice. Afrezza will survive one way or another. All those high fiving each other thinking that is game over for Afrezza, please put your hands back into your pockets. It is a shame to see DiabetesMine posting “Goodbye Afrezza”! What kind of diabetes organization would gloat even if Afrezza was pulled from the market? They are aware that it has already transformed the lives of so many. It 's hard to believe that so many want to see a drug destroyed that can help so many millions. The more I’ve been involved in this process, the more I have been sickened by the big money agenda. If you think this does not affect you, let me tell you it does. If we would have cures for many diseases you are suffering from we will never see it. Big money at play will continue to make $$$$$ off of these illnesses. The fight will continue, and I will help to try to help as many people as possible who are suffering from diabetes.”


#37

To Sam and other Afrezza users (or who are interested in trying Afrezza):

Now that Sanofi has terminated the license agreement, Mannkind has the ability to cut the price of Afrezza.

Hypothetically, if the price is low enough, say $100 per box or per month out of pocket. Will you be glad to pay out of pocket and not to deal with insurance, prior authorization and step therapy requirement?

Do you think the price cut alone will be able to increase the demand of Afrezza substantially (leaving alone the question whether the price cut itself will also enable the insurance companies to place Afrezza in tier 2)?


#38

Good question Charles— I imagine it would peak a lot of people’s interests, but I’ve heard very few reports of people actually not being able to get it because their insurance wouldn’t cover it. As I discussed in a different post l, I would pay cash for even at current prices if I absolutely had to, but not everyone has my resources.

I would think it’d be a good idea to lower the price just to drum up more interest and raise awareness of how well it works… Although I’m not sure, because the sanofi discount program brought the cash price down to not far from that level, and nobody paid attention and patients still weren’t interested—

I think ultimately they need a robust marketing and negotiation program with insurers to ensure both widespread awareness of how well it works and affordable prices in combination with good insurance coverage to be successful… Both things that sanofi failed miserably at— or seemingly didn’t even try to do…

I also think they need to do much more to reach out to educate the medical community of its benefits…


#39

[quote]In my opinion this is the biggest breakthrough in medicine that has
occurred in my lifetime— it is crazy to me that the world is just
sitting by watching it spiral down the toilet.[/quote]

How long has Afrezza been available? I don’t think it’s been very long… I know that in Canada, at least, we often have to wait months to years before medications and devices get to us…if they ever do. So I wouldn’t really say the world is sitting by watching it go down the drain, more like if a drug developed doesn’t even succeed in the country it’s developed in, the world isn’t going to take much notice. Unless maybe it’s given away for free to pharmaceutical companies, like insulin initially was… Presumably if it’s the company that developed Afrezza pulling out they have some other plan in mind.


#40

Sam, you insurance is very good. A lot of the users on Twitter reported that they have to fight with insurance to get on Afrezza.

And below is the latest on insurance:

http://www.latimes.com/business/la-fi-mannkind-sanofi-20160106-story.html

But Marcus, the Laguna Hills endocrinologist, said Sanofi’s educational and marketing efforts fell short, especially in teaching doctors how to do the FDA-mandated lung tests.

Those are tests endocrinologists don’t typically perform. Marcus said Sanofi offered a class, but no hands-on training with either lung-testing equipment or with the Afrezza inhalers themselves.

“Sanofi didn’t have a wise plan for introducing this product,” he said.

What’s more, Marcus said many of the patients he prescribed Afrezza to ended up dropping it because it wasn’t covered by their insurance.