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Mannkind and Afrezza: Reality Intrudes. Or Should, Anyway.

Inhaled insulin probably has no particular effects on the central nervous system. But there’s something about the idea of inhaled insulin that makes people lose their minds. That’s the only conclusion I can draw after years of watching this area. Pfizer led the way with a long, expensive collaboration that produced Exubera, the first inhaled insulin to reach the market. And it absolutely bombed, pulled because of catastrophic sale. No one wanted it. But when anyone suggested that this might happen, back before the launch, folks showed up from all over the place to shake their heads in amazement that anyone could doubt such a sure-fire winner (take a look at some of the comments to this old post). Not everyone bought into that, but the folks who did tended to be in all the way.

And the same has been true for Mannkind and their product, Afrezza. I’ve written about them several times, most recently here, and every time you say something bad about them someone will pop up to call you a fool who just doesn’t get the greatness of the product, the company, and of Al Mann himself. Twitter can be a good place to find these people in their natural habitat – buying more stock while wearing Al Mann t-shirts (and I wish that I were making that up). Just try a search there for “#inalmannitrust”, and wonder about what it means that there is such a thing in the first place.

I mention them today because Sanofi’s earnings are out, and by gosh, they’re having trouble moving Afrezza out the door (as had been predicted). Just like last quarter, actually – in fact, not one tiny bit better, despite the slow start for the product and Sanofi’s efforts to turn things around. Speculation already is that they’re going to dump Mannkind as soon as they contractually can, and I wouldn’t be surprised. But the true believers are still hanging in there – 2016 is going to be great, the company’s new listing on the Tel Aviv stock exchange means a big-time buyout is coming (!), everything’s going to start getting wonderful real soon now when people realize that Afrezza is the best drug ever seen by humankind. This is delusional. I know that the stock has moved up and down over time, and that at various points a person could have made a lot of money with it. But that’s true of an awful lot of stocks. In general, though, from here Mannkind looks doomed.

16 comments on “Mannkind and Afrezza: Reality Intrudes. Or Should, Anyway.”

  1. My guess is that the Tel Aviv listing is part of a scheme to force Israeli index funds to invest in MNKD. In this scenario, what would happen is this:

    MNKD dual-lists.
    MNKD is included in the index.
    Index funds are forced to buy the stock, so
    MNKD sells them stock in a direct offering.

    For MNKD this lets them shore up their balance sheet at the expense of passive index funds who have no choice but to buy the stock. The higher MNKD can pump the stock before SNY walks away, the more money they can extract from the index funds.

    That is my prediction of what is to come.

  2. Hap says:

    I think all of the people who actually used Exubera commented on your posts.

    Solving problems people don’t have, expensively, doesn’t seem to be a recipe for success. Is there any reason no one seems to have used the technology to solve an unsolved problem in a way that people would actually pay for?

  3. PorkPieHat says:

    The Tel-Aviv listing by Mannkind…any excitement about this strategy would be “irrational exubera-nce”.

  4. Brett says:

    I don’t get it, either. Shouldn’t inhaled insulin be more popular, because no more needles?

  5. MolecularGeek says:

    It’s not that insulin-dependent diabetics love injections and think that they are a great solution. It’s that insulin is relatively cheap for insurance companies to provide as an injectable solution, They aren’t going to pay for inhaled insulin as long as the manufacturer charges a premium over the better entrenched dose forms.

  6. Soon-to-be-former BMS person MOLS says:

    Diabetics who need insulin injections soon become accustomed to them; it’s not really that big a deal for them. What is a very big deal for people with diabetes is monitoring their blood sugar levels so they can adjust their diet and medications as needed to keep their glucose in the safe range. So inhaled insulin products do not address the main locus of difficulty for most insulin-dependent diabetics.

  7. Biggie Mac says:

    The partnership with sanofi will end in January. Sanofi seems to have gone quiet about european approval and marketing of the drug. The drug is barely selling in the US even with direct to consumer marketing. DTC marketing is not even legal in europe so it would be hard to sell the drug at all there. Diabetics don’t mind the injections, it is the finger pricking to measure their glucose. Now there are watches one can wear to measure blood glucose without finger pricks. Better off investing in that than Mannkind.

  8. ab says:

    It’s pretty fun reading that old post on Exubera. I believe that yummy taste in your mouth, Derek, is the sweet taste of vindication.

  9. Steve says:

    The author and none of the commenters here has any understanding of what distinguishes Afrezza from past inhaled insulin AND currently injectable insulin. Its pharmocodynamiks and -kinetics (PK/PD).

    Unless your child had T1D, you have no appreciation for the fact that it is all about blood sugar control. Less than 40% of all diabetics are in control. Less than 20% of pediatric T1Ds are in control. this means complications and early death!

    Do a little homework. Find the Diabetics on twitter that use afrezza. They are achieving non-diabetic numbers almost to a one. The doctors who allow their patients to take “the risk” are amazed. but for the most part the insurance companies and doctors are afraid of change.

    The risk either way is all on the patient. That is the true shame of this gaming the market. The drug is a life saver and its availability should not depend upon the business model of greedy people.

  10. Jose says:

    Hey ‘Steve’ any chance you could amend a conflict of interest statement?
    No?- we knew that already.

  11. Afrezza Trier says:

    I’m a T1D of almost 30 years and I posted a few times to the comments at the end of the Unkind to Mannkind post this past summer. I’ve been on a pump with Humalog almost 2 years now, pretty well controlled. At that time, I contended that Afrezza seemed like a pretty good product for T2Ds. What’s better than rapidly absorbed human insulin, no shots, versus all the drugs and their side effects. Since then, I’ve read a lot of the online reports about Afrezza from T1Ds. Google them if you’re interested. It seems almost magical. It’s weird that they also use sanofi’s newly patented basal insulin toujeo. It’s also weird that they claim A1C reductions from 10 to 5. That’s like going from not always taking your insulin to having a real pancreas. But I decided to give Afrezza a shot. Had to get a lung function test- that was fun! Had to find a pharmacy that actually carried it. It costs $150 versus $95 for a three month supply of Humalog. I got 4 unit cartridges. I tried it for mealtime boluses. I can’t figure out the dosing. 8 units seems to be a magic number for meals- 2 puffs, equivalent to what I take with Humalog. If I eat a hearty breakfast (orange juice + pancakes) my blood sugar reacts as follows (on the pump: shoots up to 200+ after 30 minutes, then trends downwards over 1-2 hours, then goes low after 2 hours; on afrezza- hovers magically at 100 for 1-2 hours, then trails upward to 200+, usually necessitating a correction puff). The online afrezza touters don’t speak about this- they must be puffing a lot to correct for the fact that afrezza dies in 1-2 hours- what happens when they eat complex carbs (bread, potatoes, rice) and need a bolus to last 4+ hours? A lot of them seem to be on continuous glucose monitors and perhaps this gives them the ability to correct quickly. I do agree with them on a few things- afrezza acts quickly and it doesn’t seem to cause lows. For me it’s been useful in combination with the pump to prevent certain post-meal highs and to treat sporadic highs. I’m a bit worried about long term effects on the lungs, I’m relatively young, so I’m going to wait on adopting it for daily use. All said, for me, compared to the pump it has some advantages, but doesn’t seem to make life easier in others.

    1. Afrezza/Mannkind Realist says:

      As a biotech PhD who has decades in tissue engineering and drug delivery (not pharma specifically), I became interested in the Technosphere delivery system and started reading about Afrezza the inhaled insulin product. Take my honesty here however you want but I was excited enough to actually take some of my IRA funds and buy MNKD stock. It could have been a very foolish move and it sure looks that way right now. Of course at this point I would like to see the company succeed. My main criticism when I got educated about the company was that they decided to incorporate insulin into the inhaled Technosphere particle format as a first product. I truly believe this was a stupid decision, however I understand that Al Mann single-handedly took this product from soup to nuts, as we say. So it was his baby. While I have a financial interest in the success of MNKD stock, I am a scientist and try to be a clear eyed realist.

      I cannot get a fair and honest read on the performance of the product. There needs to be a larger sampling of qualitative and quantitative experiences from Afrezza early adopters and longer term users. I have read about 2-3 not-so-great responses (the above included) out of about 15-20 total early adopters and users. The 15-18 Afrezza users have been very prolific and written numerous comments on message boards and a dedicated Mannkind investor board. While I understand many have a financial interest also, I don’t know of other new drugs which have garnered such responses? A few early adopters are such true believers that they have even published numerous YouTube videos, telling their stories and relating how very excited they are about the new drug. So I am perplexed and not convinced that Afrezza will ever really “take off” in time for the company to remain solvent. All users have noted that they must adjust the dosing to accommodate the different kinetics and dynamics of Afrezza vs. other RAA insulins. If I can believe it though, many of them are claiming large drops in A1C values within only a few months of Afrezza use. For instance, Eric Fenar (prolific Afrezza user / promoter) just published a new YouTube in which a young Type 1 diabetic states her A1c dropped from 8.2 to 6.5 in only a few months. This A1C result would truly be “magical” if it turns out to be the rule and not the exception.

  12. Barry says:

    sure, patients don’t love needles, and sure, companies like the idea of a new patentable entity instead of public-domain generic-priced injectable insulin. But insulin is quite toxic, with a small therapeutic index (except in Type-II diabetes) and precise dosing by inhalation takes training.
    I don’t see anyone proposing to pay for emergency medical staff to stand by for the first days as a patient learns not to kill himself/herself by inadvertent overdose.

  13. Debby Kleinberg says:

    If you were hoping to make a killing from the quick buying and selling of stock, Afrezza was never going to be the answer.
    As a parent of a type 1 diabetic, it has been very frustrating helping my daughter attempt to deal with this difficult disease for 10 years. We were basically left on our own to figure out how to manage it. Doctors were unhelpful and uninformed (even how to use the pump 10 years ago) and it became obvious the drug and insurance companies just wanted to make the largest profit possible.
    The issue with shots (easy for me to say constantly stabbing yourself is relatively unimportant) is that the insulin goes in too slowly, and blood sugar is constantly going up and down.
    Afrezza works to stop the initial spike because it goes in quickly. And for a young kid, is a vast improvement from having to stab yourself and constantly check bg and correct, constantly going low and feeling awful all the time. And then to have serious health consequences, including kidney issues, amputation, eye surgery, high cholesterol issues, etc.
    The problem with this “new” drug is doctors reluctance to alllow their patients to try something new, even though A1Cs HAVE DROPPED SEVERAL POINTS – from people documenting their numbers from the lab and daily from CGMs.
    Unfortunate that the patient is not the one that has the say.

  14. Aleks says:

    I have type 1 diabetes and have been using Afrezza for 2 months.

    The impact on my lifestyle is incredible. Injected insulin took about 50% of my daily energy. Afrezza takes 10%. It is giving me my life back.

    The reason is that Afrezza gets into the bloodstream quickly, and leaves the bloodstream quickly, JUST LIKE IN A NON-DIABETIC. This is the secret to why it isn’t any more likely for someone using Afrezza to “accidentally kill him/herself” using the drug – the human body is specially designed to avoid hypoglycemia when sudden spikes of insulin occur. I have not had any severe low blood sugar events on Afrezza, despite bringing my average blood glucose down significantly, and being MUUUCCHHH more approximate about my carb counts.

    Also, the short action period of Afrezza means:
    – Bringing down high blood sugars much more quickly
    – Greatly reduced need to keep track of “insulin stacking” of multiple doses
    – Easy to eat more food than planned; just take more Afrezza

    Anyone whose blood sugars are particularly unpredictable (like mine) could benefit from Afrezza because it allows a more responsive approach to diabetes management.

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