Sanofi ends marketing agreement with Mannkind

I had a misunderstanding when I read the article below. I thought that Afrezza was not going to be sold anymore, but now my understanding is that it is still being sold, and a sponsor other than Mankind is being sought. I apologize for my original post.

you might want to read this topic

oh no problem richard, if you want, you can click on the 3 little dots under your post and click on the trash can. but it’s not necessary. I just wanted ppl to know that it doesn’t necessarily mean Afrezza will no longer be available. many of our members are devoted to this insulin, I’m sure we’ll keep up with the lastest newws on it.

Incorrect. Afrezza remains on the market, only sanofis contract to market it has been terminated-- they are not the maker of afrezza, they were contracted to bring it to market and failed to do so effectively, so now the makers are searching for a new marketing partner

My DD has been able to get a prescription (extremely difficult even in New York City). This insulin is as close to a cure as I believe we will see for quite some time. Even for those on an insulin pump, you could use 4 unit cartridge of Afrezza for first-phase insulin response, the pump bolus for the balance of the meal. And the 4 unit cartridge does work for highs (in our DD’s case the four unit cartridge takes down her blood sugar by 90 points if it is high). Whereas her correction factor on Apidra is 1 to 70. So Afrezza dosing is very different. Insurance refuses to cover it but we are appealing and expect to win. We will pay out of pocket if they refuse. This insulin would be an asset to all diabetics even if they chose not to use it full time. It brings down high blood sugar in ONE HOUR. For that alone, I think everyone should have this insulin available. The problem is diabetics are not being educated. They are afraid to use it. Endos will not prescribe it. Insurance companies refuse to pay for it. There is a lot of money at stake here for the makers of Novolog, Apidra and Humalog. These companies have long-standing relationships with endos, medical centers, etc. This insulin will eventually cut back on a lot of their business. Hence, you have to jump through hoops to even get a script in NEW YORK CITY, and you have to pay out of pocket in a lot of cases. This insulin is the closest thing to a working pancreas (in speed of action) as we will ever get.

I would go so far as to say that for me it actually has been the cure. Not the cure of the underlying disease itself, but the cure for the heavy burden it was having in my life.

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I also want to say. Please do not pull the plug on this insulin yet. I still have hope it will survive. Sanofi did not market this drug correctly. The PROVIDERS and INSURANCE COMPANIES needed to be educated first, then the roll out to the patients. From what I am hearing Sanofi did not educate the endos. Everyone is afraid of the lung spirometry test which is NO BIG DEAL. Endos need to have the lung spirometry equipment in office (Dr. Goddard in New York City does it in office before prescribing Afrezza). But the insurance companies are refusing to pay. One big HINT for Mannkind and/or Sanofi. When rolling out a new drug, in today’s insurance market, PRICE IT COMPETITIVELY. You need more Afrezza to do the job than the other injectables. It is priced at $350 a box and we need about five boxes a month. The drug company gives you a card and they will currently pay half so it is about $500 a month for us out of pocket. WE NEED THIS TO BE AT LEAST A TIER TWO DRUG and a lot of this should have been done at time of roll out. God bless you, Al Mann, for all you have done. You are a saint in my eyes. I hope Afrezza can make it. But it won’t make it if we have diabetics pulling the plug on the drug before it has even been taken off the market. I am going to buy stock right now as I believe this drug is going to be a game changer. Just needs a LITTLE MORE TIME and a LOT MORE EDUCATION for diabetics, insurance companies and providers.

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Julia, well said. Agree with you on all the points.

To succeed, Afrezza needs:

  1. a reduced price,
  2. better insurance coverage (better tier placement and no PA requirement),
  3. better education to doctors and patients (on its benefits and the proper dosage and timing), and
  4. broader awareness.

I guess there are Afrezza users gave up (after trying some samples) because they have not been given the proper dosage and timing instruction (and they then did not figure it out by tinckering) or because of the high price and poor insurance coverage. And there are many potential users did not get access to the drug because they either did not have insurance coverage or they were denied coverage in the PA stage.

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For me as said in other Afrezza threads it is just not an option. But also a cure?? No! And the rapid will drop my bg way faster than an hour. So the yelling as in this [quote=“Julia61, post:6, topic:50293”]
It brings down high blood sugar in ONE HOUR.
[/quote] is interesting experience but still is not going to be a great selling point for me.

I did not say Afrezza is a cure. I said it is as close to a cure as I have so far seen and will be likely to see in the near future. Afrezza does drop BG way faster than an hour. Afrezza is out of the system in an hour and a half sometimes, sometimes one hour. A high BG of 325 was 170 in about 35 minutes and 135 in an hour, still dropped for another half hour a bit. Apidra, which is the fastest injectable, the down arrow on the Dexcom STARTS at 1 hour and ten minutes and takes 3 hours to finish working for our DD. Unfortunately, she won’t wear cgms anymore so we now use fingersticks. No matter, in one hour Afrezza has done the bulk of its work. The artificial pancreas will work very well. But there are young adults out there who will refuse to wear two sites. Or three. The speed of Afrezza makes it a lot safer when dosing near bed time. And for some reason there are LOT less lows on Afrezza. I do not doubt there may be some people who do not have a good experience using it. But I’m guessing it is lack of proper education and instruction as to how to use it. Also, I know some people cannot use the four unit cartridge for correction and need a two unit cartridge. For our DD – and this was a huge surprise for me – the four unit cartridge brings her down 90 points. If she is 150 she can use it and eat 4 grams… a couple of grapes, perhaps. two ritz crackers. The hoops we have had to go through to find the one endo in New York who would prescribe and the denials by the insurance companies for coverage almost ensures Afrezza’s failure. Sanofi did not promote this drug; in fact, I will quote one shareholder “Sanofi walked Afrezza into bankruptcy.” Or tried to. There is hope. But I would run, not walk, to market this in Europe at this point. And price it competitively. P.S. We have not been on Afrezza long but she would be very upset if Afrezza was no longer available.

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As far as “Physician’s approval” requirements, this need not be an impediment to getting insurance coverage. We have always worked with pediatric endos in the past, who are far more likely to challenge the insurance companies and fight for their patients. If you have an endo who won’t spend the time to fight an appeal, you switch endos. The problem with Afrezza is there are so few endos willing to prescribe it. And adult endo offices are different than pedi endo offices. It’s in and out and I believe a lot of them simply won’t spend the time required to appeal. We need choices. We need at least four or five endos in a geographic area the size of metro New York who will prescribe this drug. This drug was approved by the FDA. Tests were done. Test results read and I am confident this is safe. Certainly far safer than staying out of range three hours after every meal and snack. Adult endos need to care more about their patients and less about the bottom line… bottom line being the almighty dollar.

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Julia, agree. I think it is possible for Mannkind to publish and update from time to time a list of physicians prescribing Afrezza and insurance policies that have best coverage for Afrezza for each state or major cities. You have lists like:

http://www.afrezzajustbreathe.com/afrezza-prescribing-physicians-directory/

And website like https://formularylookup.com/

but they are incomplete and not so updated.

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Both my primary care and endo were happy to prescribe it… It’s not like the majority of doctors weren’t willing to prescribe it once they had been educated by the drug reps on the product— the problem is, the sanofi reps seemingly made no effort to do that— or when they did they totally failed to illustrate it’s amazing benefits---- and the vast majority of the diabetes population doesn’t know it exists, and a substantial portion of the ones who do know it exists, even when told firsthand how well it works, for some reason weren’t willing to try something new… Close minded stubbornness

I have been watching this train wreck for a couple years and am terribly saddened though not surprised. I had hoped very much that Afrezza could be used for people recently diagnosed with Type 2 instead of the very dangerous GLP-1 drugs, but the way the drug has been handled from start to finish made that impossible.

My take on this is that the real problem all along has been that Al Mann is an engineer and that his previous business successes had all been with devices. Engineers are logical, but anyone with diabetes of any kind who has had to deal with doctors, insurers or, for that matter, their own personal pancreas (or lack thereof) knows that nothing about diabetes is amenable to logic.

Mann assumed that because his drug worked it would succeed. He was so sure of it, that he did not bother to learn anything about how the world of diabetes drugs works. Not a single executive in the company had any experience with diabetes drugs, endocrinologists, or diabetes patients. None. Furthermore, the process for getting a drug approved is very different from getting a device approved, and the competition in the drug space was ferocious. No one at MannKind appears to have had any idea of just how ferocious.

But because this was completely Al Mann’s company and he was surrounded by yes men who were earning millions saying, “Yes, boss, everything you say is brilliant”, and because he was convinced that because the drug SHOULD work, for logical reasons, it would sell itself, the clinical trials were designed extremely poorly.

I have read all the material submitted to the FDA as part of the approval process and it showed Afrezza doing a â– â– â– â– -poor job in the real world for the average Joes who make up most of the community of people with diabetes who participated in the trials. There were severe hypos. There was mediocre improvement in blood sugar. After reading the FDA packet, I was actually surprised it got approved.

(And before an investor jumps in and tells me that the FDA forced the company to design them this way, I want to add that I have heard, privately, from a drug company executive who was involved with attempting to help MannKind design the clinical trials who assured me that the company would take advice from no one and that they, not the FDA designed the trials to be the way they were. They were so convinced that their drug was perfect they would not listen to people who were experienced with real world diabetes treatment.)

The death knell here was not competition to Lantus, or Apidra (also priced and marketed stupidly by Sanofi.) It was competition with Lixilan, a me-too long-acting GLP-1 agonist/Lantus combination drug that is Sanofi’s Hail Mary pass. The GLP-1 component of Lixilan stimulates meal time insulin secretion (and tumor growth in the pancreas, but that is another issue.)

I don’t know where you people live who could get Afrezza covered at anything approaching an affordable rate. There was not a single insurer in the entire western half of Massachusetts who covered it. No Medicare Advantage plan covered it (and in MA most people are on those plans as traditional Medicare is far more expensive.) When I asked my very smart doctor about why he wasn’t prescribing it, he just rubbed his thumb and first finger together and said, “No one can afford it.”

But that was only part of the problem. The doses available were far too small for insulin resistant people with long-standing Type 2. The only people with Type 2 who reported good results with Afrezza online were people, like Spiro, who had very mild Type 2 and who could have gotten equivalent blood sugar control with much cheaper drugs like repaglinide. I heard from several others who tried it (on their own dime) who were underwhelmed with the effect it had on their blood sugars. They would have needed three or four boxes a month–and education which they didn’t get about how to do correction doses. Type 2s never get any formal diabetes education and have never heard of correction doses.

And make no mistake, the Type 2 market is where all the money is in selling Diabetes drugs. Without packaging, pricing, and marketing Afrezza properly for Type 2–and most importantly for* early* Type 2 where it could be extremely effective without need for basal insulin–the drug is a flop.

I got increasingly angry about how Afrezza has been handled by MannKind the more I studied the history of the drug and the way it was being marketed. I was so hoping it could transform the treatment of Type 2 for many people were it handled properly. But it wasn’t. The clinical trials which cost many hundreds of millions probably sealed its fate.

And because of the barage of exaggerated claims about the drug made by MannKind, which are refuted by the studies they conducted, it will be unlikely that anyone from industry will want to touch this drug. The only people who might understand what it is and why it needs to survive are those of us with diabetes who have used insulin. Let’s hope that someone who fits that description and has a huge pile of money falls into that category and steps in and rescues this drug.

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Well @Jenny, it worked amazingly well for me as a tightly controlled type 1 diabetic who learned how the product worked by actually using it and paying attention to my own results. I can agree with a lot of what you say that they botched this or that or made wrong assumptions about how the drug market works, but I’ll never agree that they didn’t design the most effective insulin the world has ever seen.

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Hi @Jenny - Sam and I are on the same page here. We are living examples of tightly controlled T1’s who have had amazing success with Afrezza. You can read and say all you want about how awful the drug did in trials . . . we use it daily in the real world and it works tremendously well and it would be a huge disappointment if it went away. I have had ZERO severe hypos since starting it in February of last year.

Your post is on point as it relates to the target marketing and launch of the drug and I won’t comment on whether or not I believe the drug is more appropriate for T2’s. Sanofi was the wrong partner, period.

Oh yeah, I live in Maryland and have had no issues at all getting my insurance to cover it.

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But are you and Sam really average real-world examples? @Sam indicated that he had an A1c of 4.9% on injections. I would not call that average. So far all of the praise of Afrezza I’ve been seeing (on this site, at least) come from people who already had excellent control to begin with and were just looking for something that was more convenient and faster acting. How does Afrezza work for the average Type 1 who is maintaining an A1c of 7.9% on an insulin pump…

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Sam19,

For some people, yes, Afrezza does look like the most effective insulin, and we have heard from those people ad nauseum online over the past year. But the number posting enthusiastically about the drug has been a tiny percentage of the number of prescriptions written over this past year. Take away the people who have been posting almost daily since launch, most of whom are investors or have some other connection with MannKind, and the number is even tinier. Most notably, it hasn’t grown as the number of prescriptions has grown. Obviously, many people who have tried Afrezza have not had the same kind of life-changing response.

I think that what you and many others involved with this drug have lost sight of is that diabetes, whatever its type, affects different people very differently and different drugs work very differently from person to person. The best drug for one person may not be the best drug for another. And over time drugs that work really well for one person may stop working for many different reasons, too, or may cause unexpected, and very nasty side effects that did not show up in a few years of clinical trials.

If Afrezza had been promoted as what it was, a replacement for first phase insulin, with the applications appropriate to such a drug, and if it had been tested to show what that meant–which would have involved designing completely different kinds of trials and marketing it in a way that accepted that it would remain a niche drug for quite a while, it might have worked out. This could have happened if the company hadn’t wasted so much money on seriously stupidly designed trials that ignored the FDA’s requirements and put the company into a position where it had to make a lot of money very quickly to make up for years of mistakes.

But instead, from the beginning it was promoted as a drug for people with Type 2, in a world where there are already a lot of drugs that will lower A1c to the stupid, but universally adopted A1c levels doctors have been told to shoot for. And they do it without any risk of hypo. To get doctors prescribing Afrezza vs a much cheaper lineup of blockbusters that don’t cause hypos was a herculean task that would have required clinical trial results showing a drop of 2 to 3% in A1c for patients starting at A1cs of 8 or 9%, virtually no hypos, and a price that was truly competitive unit for unit with injected insulins and, more importantly, competitive with Invokana and Januvia.

And I have seen zero evidence that Afrezza is the best insulin ever seen for people with Type 2. They are going to have a much longer, slower release of glucose from meals and that makes a very fast insulin less useful than, say, Novolog for most. Remember, no one gets put on insulin with Type 2 until they have had terrible blood sugars for many years, enough to have damaged their vagus nerve and messed up digestion. Most Type 2s on insulin are older, and hypos are a real problem because of that gastroparesis.

Yes, I would call myself an average T1. I wear a pump, a CGM and take insulin. I have had A1c’s in the 7’s, 6’s and 5’s. I am by no means perfect when it comes to my treatment of diabetes. Not to mention I think whether or not we are “average” T1’s is besides the point. We are talking about the real world efficacy of Afrezza and how it compares to other subQ insulins (i.e. Humalog). My personal experience has shown that the use of Afrezza has significantly reduced my post-prandial excursions while limiting dangerous hypos. These facts alone cause me great concern as it relates to potentially losing access to Afrezza.

Afrezza does not care whether your last A1c was a 9.2 or a 5.1.

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Jenny, have you ever used insulin?