ADA 2023

[sayhey24]

In don't think so - "So what went wrong. In a word, Exubera. Commercially it was an utter failure because there was no compelling case."

What? What went wrong was the entire industry saw afrezza as an incredible threat and threw everything including the kitchen sink, stove and refrigerator at afrezza and then Al got sick. The Exubera cancer scare was suppose to stop Al from afrezza development but Al did not stop.

Exubera which is still an approved product has three issues; the inhaler and dosing suck; its PK profile is no better than an RAA; and the big one afrezza. Pfizer never put the marketing into Exubera. They did not want to make the market for afrezza per their lead scientist. At the same time glp-1 were in development and BP saw this as the next big money maker as long as afrezza did not mess up the T2 market for them.

15 years later we know glp-1s have made a lot of money but for diabetes they have a two big fails; after a year A1c starts to rise; they have little value in controlling post prandial glucose. Additionally, most people stop taking for whatever reason after a year.

At this point BP is making so much money in the diet space with glp-1s they are less focused selling them into the diabetes market and they need to get rid of the shot even if they have to go back to daily pills.

For afrezza to succeed it needs; great results from the kids trial for the T1 market; great results from the India trials - assuming it hits the 1.5 - 2% A1c reduction Mike mentioned - afrezza is now in the same range as glp-1s for the T2 market; and it needs no pre auths for Medicare market; and MNKD needs a serious partner whether its a BP or an Abbott or Dexcom or Big Tech.

[sportsrancho]

“Some very good points being made about changes in market, heavy lift for new paradigm-changing drugs, and strategies for growing Afrezza. To them I’d add one simple point: Afrezza can do what nothing else can In bringing BG back into the normal range. To make a comparison to another disease, HIV used to be treated in various ways that prolonged life but ultimately the disease still won. Patients died. Recall what all of us old enough to remember thought when Magic Johnson announced he was HIV positive. He’s gonna die. Well, we know how that story ended. Great advances in meds saved Magic and many others. Today HIV is controlled.

Diabetes is not. Not even close. Yes there are better tools and diligent patients can achieve greater TIR and lower A1c. All good but not good enough. To use an analogy, we just have put better Bandaids on the wound. We haven’t healed the wound. It is still my opinion that Afrezza heals the wound. In some cases literally. Afrezza does what nothing else can: with proper dosing return the patients to a physiologically nondiabetic state while on therapy. It also produces true reversal of disease. It does all this with the same chemical that the body naturally uses to control BG. So no side effects. Some of the newer therapies are good additions to the tool kit but none are Afrezza.

The most important take away from all these posts IMO is the heavy lift of a new drug. It’s really huge. And in some cases the strategy used to promote has to be waaaaayyyy outside the box bc the marketplace is so ossified in the way things “should” be done.

I continue to believe Afrezza will win its place as THE DOMINANT DRUG FOR DIABETES—Al’s belief. It’s just that good.”

~Bill McCullough
CEO Vdex diabetes

[prcgorman2]

Thank you sports, Sayhey, agedhippie, et al. Been some really great posts of late.

But about ADA, how's that going? Any posters, whitepapers, presentations? Or is it 100% going to be only some MannKind folks attending and available for business discussion? (Which reminds me of Hakan Edstrom's pathetic plea for anybody interested in a possible business deal to contact MannKind.)

If there's nothing more to say about ADA, perhaps we should move some of the really great posts to a more appropriate thread?

[sayhey24]

OK - Sports, I was going to give you full credit for a great post but then I see Bill's name - good grief!

I have a real problem with the way TIR is being evolved and is being used. The 70-180 24hr TIR which is becoming the "norm" is not giving us a true picture at addressing the hard problem. The hard problem is when people eat their blood sugar goes crazy. IMO, at a minimum TIR needs broken into two separate TIRs; awake; and sleeping.

For the T2 do we really care about when they are sleeping? I would say for the most part no. If when they go to bed they are at 95 mg/dl their pancreas should carry them through the night with no issues. The key is post prandial control and returning the T2 to a non-diabetic range under 140 asap.

For the T1 its a different story as their basal needs to carry them through the night and requires adjustment.

For Aged's AID pump - it does a super job when the T1 is sleeping but can not match up to afrezza for post prandial control. However, when you mush the two TIR periods together and you provide the 180 upper limit, it tells a different story but its the story the AID pump vendors want to tell.

[cretin11]

Agree with Bill McCulloch on the above, including that the strategy to promote Afrezza needs to be way outside the box. Not sure we have the personnel in place to accomplish it, which leads to sayhey24's point that MNKD needs a serious partner for it. After years of having no more success selling Afrezza than Sisyphus pushing his rock up the hill, that point seems clear now too!

[mango]

This video from Bill of VDex is still single handedly the best piece of work this man has ever produced. Wish Bill would start these types of videos again. I think they took the videos down from their Youtube channel, but they are still accessible from a foreign Facebook.

Love the intro to this first one, and the chuckle Bill makes at the beginning. I always laugh watching this! And as Bill points out, Metformin is a gate-way drug and it’s damn near irresponsible to prescribe it. Could not agree more! 

m.facebook.com/vdexdiabetes/videos/the-problem-with-metformin/1502605086493297/


m.facebook.com/vdexdiabetes/videos/the-superiority-of-afrezza/1509020665851739/?locale=ms_MY

[prcgorman2]

Jun 15, 2023 10:52:42 GMT -5 cretin11 said:

Agree with Bill McCulloch on the above, including that the strategy to promote Afrezza needs to be way outside the box. Not sure we have the personnel in place to accomplish it, which leads to sayhey24's point that MNKD needs a serious partner for it. After years of having no more success selling Afrezza than Sisyphus pushing his rock up the hill, that point seems clear now too!

Do you also agree with agedhippie's, stevil's, and matt's views that being able to persuade prescription of Afrezza has to be based on science proved by studies?

I too fell into the trap of simply thinking all that was needed was inspired marketing, but I was eventually persuaded that this view was the path to wasting money and time, but mostly money.  Hopefully, you too will eventually come to agree with this view.

The results of the India CIPLA trial and more fundamentally, the Pediatric Trial, are needed.  The pediatric trial especially because it has a goal proving superiority, not just non-inferiority.  That is the kind of data, available only from studies, not marketing, that can "move the needle".

And, that's the kind of data we could hope to see generate posters, whitepapers, and presentations at ADA.  ADA really isn't the place to try "out of the box" marketing gimmicks (although Sayhey's version of "Seeing is believing" always appealed to me, it probably wouldn't have been usefully persuasive with endos).

[cretin11]

Though we never had inspired marketing, that component alone was never gonna cut it. Glad you were eventually persuaded, so we agree on that aspect of the equation. It will require a multi-faceted approach (obviously including science), as does any new drug. And Afrezza in particular will require an outside the box strategy. Bill gets it! Hopefully our folks will too (whether that is the team we have currently or not), and as sayhey24 said it sure would be helpful to have a serious partner.

[akemp3000]

Michael Castagna agrees with everyone here that a big partner is needed. He's mentioned this several times in the past. For whatever reason, possibly the Sanofi debacle, a good partnership has never been reached. I like to imagine that a BP deal could be progressing behind the scenes and is only pending pediatric approval. That could be the ideal time for a serious BP to step in.

[sayhey24]

Maybe Bill can grab that booth at ADA2023 that MNKD did not want which is right next to Dexcom and I can get my megaphone and we can do some live "Seeing is Believing" demonstrations.

[mango]

I could see a BP player want to step in following the successful Afrezza Peds trial. If we generate really great results we are talking about penetrating an entirely new subset in the diabetes market. We’re talking about making people Afrezza Users for life.

So we’re talking about not only providing a really great product that is completely different than traditional insulin products, we’re also talking about creating an experience for the user and having a really great company behind both of those things. Mike has started the rebranding and is trying to build a good culture and experience. What’s traditional for BP is to pump out drugs. They are too big and too concerned with pleasing shareholders and making money to give a unique experience and revolutionary products like MannKind can.

Being able to tap into the Peds market sets MannKind up for creating life-long Afrezza Users which is a huge deal if you think about it right? These people may be on Afrezza for over half a century! Hopefully Mike pivots the Endocrine Business in the right direction for creating an experience, being one of the few parma companies that are doing things for the patients first and not the money, right?

People talk about Afrezza differently compared to any other drug on the planet. It’s an essential life supporting agent these kids will need for the rest of their lives so really giving them a good experience right off the bat is essential.

I also the VDex has an important role in this as well because they are providing that clinic experience that is incredibly rare. Hopefully VDex gets a flood of new patients following Peds approval. I think it will be essential to have these intimate clinical relationships like VDex provides.

[lennymnkd]

Jun 15, 2023 14:07:54 GMT -5 sayhey24 said:

Maybe Bill can grab that booth at ADA2023 that MNKD did not want which is right next to Dexcom and I can get my megaphone and we can do some live "Seeing is Believing" demonstrations.

Now that would make a great commercial 🤔

[sayhey24]

Jun 15, 2023 14:22:47 GMT -5 lennymnkd said:

Jun 15, 2023 14:07:54 GMT -5 sayhey24 said:

Maybe Bill can grab that booth at ADA2023 that MNKD did not want which is right next to Dexcom and I can get my megaphone and we can do some live "Seeing is Believing" demonstrations.

Now that would make a great commercial 🤔

Its in San Diego this year.  I would be coming from OBX so too far to throw my ladder in the back of my truck and drive.  I am sure there is a HomeDepot out there some where I can get a 10' ladder. 

[agedhippie]

Jun 15, 2023 13:34:27 GMT -5 akemp3000 said:

Michael Castagna agrees with everyone here that a big partner is needed. He's mentioned this several times in the past. For whatever reason, possibly the Sanofi debacle, a good partnership has never been reached. I like to imagine that a BP deal could be progressing behind the scenes and is only pending pediatric approval. That could be the ideal time for a serious BP to step in.

The problem is simply that BP no longer believes in inhaled insulin. They have seen two of their own fail (Pfizer and Sanofi), and eight years after launch Afrezza sales are a rounding error in the market. It's hard to emphasis how negligible the Afrezza market share. Take just Humalog (ignore Novolog and all the newer insulins) who had TRx 726.4k in May, Afrezza TRx was 3.8k. Afrezza undersold even Humulin R which nobody should be using at this point by 8:1.

I think pediatrics has the potential to double Afrezza sales, but not much beyond that because endos are pushing AID pumps. That's my opinion, but it based on talking to several endos in the big NYC teaching hospitals (donate to hospital groups; (a) it helps the diabetes centers which are never profit generating, (b) it gets you access to people) I think it's likely correct.

Mannkind owns Afrezza whether they want to or not so it's high time they did something about improving sales and that means large trials to get the data proving superior outcomes in various scenarios. Then you may see a partner emerge, but maybe you wouldn't want one at that point...

[bthomas55ep]

Jun 15, 2023 17:06:53 GMT -5 agedhippie said:

Jun 15, 2023 13:34:27 GMT -5 akemp3000 said:

Michael Castagna agrees with everyone here that a big partner is needed. He's mentioned this several times in the past. For whatever reason, possibly the Sanofi debacle, a good partnership has never been reached. I like to imagine that a BP deal could be progressing behind the scenes and is only pending pediatric approval. That could be the ideal time for a serious BP to step in.

The problem is simply that BP no longer believes in inhaled insulin. They have seen two of their own fail (Pfizer and Sanofi), and eight years after launch Afrezza sales are a rounding error in the market. It's hard to emphasis how negligible the Afrezza market share. Take just Humalog (ignore Novolog and all the newer insulins) who had TRx 726.4k in May, Afrezza TRx was 3.8k. Afrezza undersold even Humulin R which nobody should be using at this point by 8:1.

I think pediatrics has the potential to double Afrezza sales, but not much beyond that because endos are pushing AID pumps. That's my opinion, but it based on talking to several endos in the big NYC teaching hospitals (donate to hospital groups; (a) it helps the diabetes centers which are never profit generating, (b) it gets you access to people) I think it's likely correct.

Mannkind owns Afrezza whether they want to or not so it's high time they did something about improving sales and that means large trials to get the data proving superior outcomes in various scenarios. Then you may see a partner emerge, but maybe you wouldn't want one at that point...

The ole pesky chicken or the egg strikes again.