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How much do you really know about the only inhalable insulin? This week, Stacey interviews the CEO of MannKind, makers of Afrezza. Mike Castagna talks about how Afrezza works, misconceptions about the product, the worldwide market, pediatric studies and lots more.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

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Episode transcription below:

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Stacey Simms  0:00

Diabetes Connections is brought to you by Dario health manage your blood glucose levels increase your possibilities by Gvoke Hypopen the first premixed auto injector for very low blood sugar and by Dexcom take control of your diabetes and live life to the fullest with Dexcom This is Diabetes Connections with Stacey Simms. This week all about Afrezza How much do you really know about the inhalable Insulet. I had a great conversation with the people who make it

 

Mike Castagna  0:34

For me, it’s about using the right product to meet your needs to get you in control. And if you’re doing well, great, we’re going to avoid the long term complications. But if you’re not doing your health, and you gotta really try to find the best set of tools, they’re gonna make you successful and fit your lifestyle.

 

Stacey Simms  0:47

That’s mankind CEO Mike Castagna. We talked about how Afrezza works misconceptions the worldwide market pediatric studies and lots more. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Welcome to another week of the show. We so glad to have you here we aim to educate and inspire about diabetes with a focus on people who use insulin. And this week, we’re talking about the use of the only inhalable insulin, my son was diagnosed with type one right before he turned two, he is 16. My husband has type two diabetes, I don’t have diabetes at all. But I have a background in broadcasting. And that is how you get the podcast, I have to say that personally, my family is very interested in Afrezza Benny really would like to try this seat. Of course, as I mentioned in that tease up there, they’re looking at pediatrics, he is still under 18. So it’s not proof for his age group. But we’re watching it really closely. And I have a lot of friends. A lot of bloggers and people in the diabetes community have talked about this for years. And some things have changed. So I wanted to have them on the show and find out more. So a little bit of background for you. If you are brand new to all this, Afrezza was approved in the United States in 2014. And the company that makes it is mankind. For a while it was sold by Santa Fe, but then mankind took it back. It’s one of those things where sometimes the business side seems to have gotten more attention than the product itself. So what is Afrezza it is a powder, it comes in cartridges, and you suck it in you inhale it with a special inhaler device. To me, it looks more like a whistle than a traditional inhaler like an asthma inhaler. It’s not like a big tube. I’ll link up some photos in the show notes. I’ll also link up the Afrezza website so you can learn more and see their information.

And my guest this week is Dr. Mike Castagna, the CEO of mankind now he has a Doctorate of pharmacy, he worked as a pharmacist behind the counter for CVS at the start of his career. But then he went back to school and he got an MBA from the Wharton School of Business. He’s fun to talk to he doesn’t mince words, and he truly believes in this product, I do have to tell you that Mike mentions monomeric insulin a couple of times, I’m going to come back after the interview and explain more about that give you a better definition. All you really need to know is that it’s faster than how liquid insulin is made. And all of that in just a moment.

But first Diabetes Connections is brought to you by Daario. And over the years I find we manage diabetes better when we’re thinking less about all the stuff of diabetes tasks. That’s why I love partnering with people who take the load off on things like ordering supplies, so I can really focus on Benny, the Dario diabetes success plan is all about you all the strips and lancets you need delivered to your door, one on one coaching so you can meet your milestones, weekly insights into your trends with suggestions on how to succeed, get the diabetes management plan that works with you and for you, Daria is published Studies demonstrate high impact clinical results, find out more go to my dario.com forward slash Diabetes Connections.

Mike, thanks for joining me, I’m really excited to catch up. And look, I’m stuttering because I can’t believe this is the first time we’re talking to you. But thanks for coming on. Oh, thank you, Rodney. I’m super excited before we jump in and start talking about Afrezza Can you give us some perspective kind of dial back because mankind is not. It’s not a name that came out of nowhere? There’s really important history. Can you kind of talk about that a little bit first?

 

Mike Castagna  4:14

Sure. Mankind comes from our founder named after Al Mann and Al Mann was a true innovator. He started I think 17 companies and everything from the cochlear implant to the pacemaker to insulin pumps that many of us know today as Medtronic used to be called mini med. And Al Mann built the insulin pumps over the 80s and 90s and was very successful and sold that company to Medtronic. And then he took literally $1 billion of his own money and invested in mankind. And he had put this company together through three companies he owned the technology to make Afrezza was really a combination of companies and the reason he was so dedicated as he saw in the pump market, which we now see today on CGM was that the variability in mealtime control was so high and the fluctuations you see that the influence takes about an hour and a half to kick in. And it’s hard to get real time control if you can’t get a faster acting insulin. And so he set out to make a real time acting insulin, so phrases and hailed as monomeric. And that was really what the magic was in our technology making a dry powder was was free dryness, if you heard of dippin dots ice cream, we have basically large dipping machines in our factory, but we free dry the particles to make a freezer and under stabilize the monomeric form. So when you’re inhaling, you’re inhaling influenza, as soon as it’s in your blood is active, or when you inject it has to hold hexamer and has to break down there were about 45 minutes. And that’s how you can make it stabilize an injectable form. But it has to break down and then it starts working. And that’s why there’s always this lag effect between we see injectable and foam in and help us is very different products were categorized with real time rapid acting, but the name mankind comes from elmen and the guy who probably 60% of people on pumps have their own pumps that he created. So amazing gentlemen, huge contributions to diabetes and millions of people were alive today because of his work and his generosity and roven to take that forward here and kids and frozen inhaled insulin.

 

Stacey Simms  6:06

I mean, never look at dippin dots the same again.

 

Mike Castagna  6:10

I see a large factory of they don’t like it, you know, we can always make different types of things don’t go well.

 

Stacey Simms  6:15

I love it. Let me ask you to go into a little bit more detail about how someone who uses Afrezza would actually use it. Can you talk a little bit about like a daily routine?

 

Mike Castagna  6:25

Yeah, I mean, I know, you know, well, you’re in this disease. I mean, people sometimes graze all day, and they just kind of ride their sugars and take a little bit some along the way or many boluses. And some people you know, eat once or twice a day, or some people, you know, carb restricted and everyone has a different way. And I think that you know, the big thing difference was for the patients that I see is, it’s in the moment, meaning you don’t have to time your meal and your insulin, when you’re going to take it and where you’re going to be. As soon as your food arrives. You take your first dose.

 

Stacey Simms  6:50

Most people I know who use Afrezza take a long acting insulin with it. Is that pretty standard for people with type one?

 

Mike Castagna  6:57

Yeah, I’ll take one year, right? Yeah, you need a basal insulin of some sort, you know, and, and a meal time was held, we do have some patients on pumps where they will use their punches for their basil, for example, and use a phrase for real time corrections. So you know, the average patient is very different. We have some patients that are type twos, you know not not on any basil, you’ll need to be on basil for if you’re type two. But if you’re type one, you need to basil, long acting insulin, and you need your meal time. And we know the biggest problem in this country is still mealtime control is the number one thing people with diabetes struggle with. And it’s a big reason why, you know, six, or seven or eight, you know, eight out of 10 people basically are not a goal on insulin because of the mealtime control. So it’s a daily challenge for everybody.

 

Stacey Simms  7:39

Can you talk a little bit about how Afrezza is kind of measured out? Because when we think of mealtime, insulin, everything’s a carb ratios. And especially as I mentioned, if you’re on an insulin pump, you’re you’re putting in the carbs that you eat. So how does that work?

 

Mike Castagna  7:51

Yeah, it’s funny, I get into many debates with people because, you know, I’m a pharmacist by training, but I’m not the smartest guy. But I couldn’t do all the work people do every day to influence sensitivity ratios and carb counting and timing. And all I can tell you is everyone’s masks off by 50%, one direction or another. And so we have this false pretense that we’re that accurate. And dosing are influenced by down to the half a unit or one unit. And the reality is your angle of injection can decrease, you know, change your absorption by 25%, your site of injection can change absorption, your your stress level can change your impact with your insulin, there’s so many things that go into your daily dosing of insulin, that, you know, being that precise, down to the unit is not as accurate as we all think. And I think that’s that’s one of the misnomers of, you know, the timing is what you really struggle with when you’re using injectable insulin, and you just don’t know what’s going to happen. You know, when people I guess doctors often you know, you don’t have to carb count with Afrezza . And they give me funny looks. And the reality is, you know, we’ve never done a study where you’re carb counting to get your dose of insulin, that’s, you know, so becomes a four 812 dose linear all the way up to 48 units, it’s additive, and you just got to be close enough. And so it’s about a two to one ratio, you know, there’s no direct pulmonary equivalent to injectable insulin, unfortunately, but, you know, people are taking five units of injectable insulin per meal, they’re gonna need about eight units of Afrezza and maybe even 12. And you’re gonna figure that out, it’s your first meal or two what what the right dose is for you. But you just got to be close enough. And that’s a big misunderstanding for people of how accurate the dose has to be. This is the sixth dose cartridge is a big problem. I know plenty of type one patients who take for a 1224 meal, especially they haven’t Chinese food or sushi, they just they dose a lot. So I think that’s something people have been comfortable, so dramatically different than anything they’ve ever been trained or taught in their history of living with diabetes.

 

Stacey Simms  9:36

I would assume that a prescription for Afrezza comes with a doctor’s visit where someone whether it’s someone who works for Afrezza, or the endocrinologist talks to you about how to do this dosing. You said you figure it out, but I’ve got to assume that you’re not just sending people home with this inhalable and say, just test it, I mean, right somebody, you’re at a ratio

 

Mike Castagna  9:59

and I think That’s the key thing is, you know, having patients understand because it’s odorless and tasteless. So you inhale, and you’re like, what did I get it? And I’m like, yeah, if you inhaled, and I have the second, it’s in your blood, it’s in your lungs, it’s breath activated. So you can’t really, of course, you can try to mess up something. But we have something called Blue Hill, where we can show proper inhalation technique in the office on an iPhone app or an Android. And so you know, we hope that patients are being trained either by our trainers or the doctors offices, and will propagation technique looks like that’s number one. And then number two is the right dosing. And as you know, individualized dosing is important and fun. And, again, that’s why I say we take a lot of the math out because it’s either gonna be a four or an eight, and all of a sudden, you’re like, Oh my god, I’m gonna take an eight units, it’s a lot it’s really not when you’re taking inhalation units versus injectable units and that’s what people got to get comfortable with if their first or second dose so they really do figure out this meal did this or pizza is going to take longer so pick another dose and now our people do figure it out pretty much within the first week. And then there’s one thing actually I want to mention because I often forget this is because injectable insulin is such a long tail it’s in your body for four to six hours before it’s out and that feeds into your basal rate your long acting and so when people switch over presence pretty much out of your body in a net roughly an hour and a half. Sometimes people need to adjust their basil and that’s something to watch out for if you do switch to Afrezza enter you’re struggling with with some of the basil rates. Some patients you know I hear people anecdotally you know, we don’t want to study their the bump up their basil 10 15% on Lantus. And I’ve heard patients on to see that because it does have that long tail of down there in front sometimes on the basil. So there are the other metrics patients have to watch out for when they are switching to the product. It’s not just the uptime, it’s also something that basil where you look at

 

Stacey Simms  11:38

I have a question and I i apologize because it’s a it’s a bit ridiculous. I’m gonna ask it anyway.

Right back to the interview in just a moment. But first Diabetes Connections is brought to you by Gvoke Hypopen. And our endo always told us that if you use insulin, you need to have emergency glucagon on hand as well. Low blood sugars are one thing we’re usually able to treat those with fast acting glucose tabs or juice. But a very low blood sugar can be very frightening. Which is why I’m so glad there’s a different option for emergency glucagon, it’s Gvoke Hypopen. Gvoke Hypopen is pre mixed and ready to go with no visible needle, you pull off the red cap, push the yellow end onto bare skin and hold it for five seconds. That’s it, find out more go to Diabetes connections.com and click on the Gvoke logo. Gvoke shouldn’t be used in patients with pheochromocytoma or insulinoma. Visit Gvoke glucagon.com slash risk. Now back to my interview with Mike, where I will ask that ridiculous question.

 

You had mentioned it’s tasteless, odorless, I recall hearing and I’ll have to fact check this. But I recall hearing that years ago dandruff shampoo, they had to add like that tingly feeling because people didn’t think it was working like it’s totally fake. But people just didn’t believe it was a medicated shampoo because it didn’t have an unpleasant sensation. Have you thought or talked at all about adding like a flavor or a feeling to so people really know that they got it? Or is that just really bananas?

 

Mike Castagna  13:12

If somebody might company come and talk to you ahead of time? There’s somebody internally who wants us to look at like cherry flavor Afrezza especially as they go into pediatrics? And the answer is, look, there’s blueberry Metformin because the metformin smells awful and tastes awful, probably. So you know, those things are possible. We’ve never done them. And to my knowledge in this industry with dry powders, it is a question that came up recently. Is that should we be thinking about the cherry flavor Afrezza or some other flavor? And I think the answer is TBD. We I don’t know what the date is on inhaling the food coloring dye or whatever. Yeah. But that’s some of the stuff we have to justify that it’s safe and effective. And along with FDA would want us to test but they come up recently and another internal discussion. And since you’re asking, I think we’ll look at it, even if maybe there’s a way to even show a placebo, that’s a cherry flavor or something right a one time dose to see what it’s like. So I don’t know. But now, but people like I said, it’s sometimes you get a call, like you know, when you take a phrase of one out of four people will get a cough initially. And generally there were the first four weeks that cough goes away 97% of the people. So I always tell people, you’re having a cough, like as long as not interrupting your life, it should slowly get to your first refill. And it should be mostly resolved by that your body’s getting used to putting a powder in your lungs. But that’s uh, you know, when people ask, what’s the difference between injectable and inhaled in terms of safety, you know, you’re putting a drug powder in for the first time in your body and your body could choose that. And the number one thing that’s different, were injectable insulin. You know, you have other other things. You’re dealing with injection sites and pump sites and scar tissue and things like that.

 

Stacey Simms  14:48

Does the body actually acclimate to the powder or is it just a question of someone gets better and used to the inhalation sensation?

 

Mike Castagna  14:55

You know, it’s it’s a good question. I don’t know if I have a black and white answer here. bodies give. Yeah, my guess is the body’s getting used to putting a dry powder in and just exit and you get used to like weed. You can drink a glass of water before and after and help you minimize it. But it’s generally like that’s what it feels like it’s not a productive call frightening, there’s not a call to happens 10 minutes later, it usually happens. We have to inhale.

 

Stacey Simms  15:17

You mentioned BlueHale , can you tell us a little bit more about what that is?

 

Mike Castagna  15:21

Yeah, so BlueHale  is to two different things. The first one that we’re looking at is with the patient training device. So we can show you whether you had a good emulation or not a good emulation and show you that technique. The second version, actually, you can detect with those you put in the cartridge and hilar. So it has a proprietary software there that we can see what cartridge you put in for the adapter. And it’ll tell you on your app, if you took a for a 12 or 16, how much you took in that session. And then we hooked integrate that with the CGM data. So now you can show those response curves on CGM one day and eventually I want to get into AI and predictive analytics. But we’re not there yet. But we think that’s the magic of what people really want, which is one that I use the thing when you live with diabetes, you just must remember and be that perfect to know exactly what those you did with them. You took it, what meal you were and then I simulated being a patient for a week. And I realized I could remember if I took a four and eight, I take a six or 620 is that 30 minutes or one hour like it was it was amazing. When you just think about life and people are human. They’re there. They’re human. So they’re not keeping track. And they’re not that accurate. They’re just estimating. And that’s when I talked about the dosing of insulin, like we’re always estimating everything, we’re estimating the time our food is going to come and how long it’s going to work. You know, what the carbs are? How much am I gonna eat or drink? Like, it’s all accurate? It’s all off. None of it’s that accurate. That to me is the thing I realized when I was thinking of doing one of those a disease, you don’t you think they’re perfect. They’re not. They’re human beings. And that’s when I see one out of five doses of injectable insulin are intentionally missed. And the predominant one that’s missed is actually lunchtime, which makes sense to wear out in a social environment. They don’t want to inject. And by the time they get back, they forget it’s probably too late. Or you’re already high.

 

Stacey Simms  17:00

What do you mean by intentionally Miss? You mean? Like they people just forget?

 

Mike Castagna  17:03

No, no, they intentionally knew they should take a dose of insulin, but they’re in a lunch conversation, or they forgot their insulin in the office. Or they’ll have their CGM receiver on the bike, or they essentially don’t they miss one of the five doses. So if you’re missing 20% of your doses, it’s really hard to get in control. And there’s all kinds of reasons, but that’s intentional omission versus unintentional. Which is I forgotten.

 

Stacey Simms  17:23

I’m curious what the sources on that that’s, I mean, I don’t doubt it. I’m just curious.

 

Mike Castagna  17:27

Yeah, I couldn’t find it. follow up on that. I have your email, I’ll look for it. Yeah, no, because I didn’t believe it. And then there was a study done with one of the pens coming out that has digital connectivity. And I looked at it and I looked at the data and like, wait, if a person needs three times a day, seven days a week, that’s at least 1721 doses, right? And I think the average person is taking like 1212 shots a week. And I’m like, Well, that doesn’t make sense. But you realize, you know, again, we’re human, people aren’t always as compliant as we want, or they don’t eat three times a day perfectly are the two big meals, you know, everyone does something different. So having insulin that meets your needs, and your lifestyle, I think is really important in the world. And you know, look, we like our products, obviously, we’re here, we love the Afrezza. But But I also just for me, it’s about using the right product that meets your needs to get you in control. And if you’re doing well, great, you’re gonna avoid the long term complications. But if you’re not, you own your health, and you got to really try to find the best set of tools that are going to make you successful and fit your lifestyle. And, you know, obviously, we’re not doing well when 80% of people on insulin on a boat. I mean, that’s that, to me is the number one thing, I look at this country and say, well, despite all the adoption of pumps, and technology and CGM, we still have not made a meaningful difference in percent of people to go. And that’s frustrating.

 

Stacey Simms  18:35

Way back in the beginning of this interview, we talked about Chinese food and pizza. And I’m just curious, you know, these are things that are hard to dos for, because they they kind of they come later, you know, what most people listening are very familiar with, and I think probably have their own system for dosing, whether it’s an extended bolus or injecting more than once. How would you do something like that on a Friday? Is it a question of you would take what you think when you’re eating, and then again, in a bit later, like, how do you account for those high fat foods?

 

Mike Castagna  19:02

Yeah, you know, I’m going to pick on Anthony Hightower, who I know you interviewed before. So I actually met Anthony on a bed over social media. And he had showed me your servers where he ate pizza. So I’ll pick on him because I want the public discussion here, sir. He pizza and his sugars are basically flat over the two, three hours post meal. And I said, I’m like, shocked. He’s like, this is something people cannot do naturally on the history of injectable insulin, they they always struggle. And when you eat pizza, you’re going to struggle not just for hours, but potentially for the next day because just throws everything off. I think in his case, right? I’ve watched him he took a big dose up front, you know, let’s say he’s gonna take 12 units of injectable he took 24 units of Afrezza. And then he washed her wasn’t an hour, and then an hour she was above where he started. He took another dose, maybe took a four and he has to tap it off. And then an hour later, just thought was too high or not right. But you can always keep your sugars in that kind of control. That’s one of the studies we did back in 2018, called this test study was showing that you could do as soon as one hour with no more hyper risk. And that was a big concern of people, how can I do that one hour, well, pretty much hit its peak effect in one hour. So if your servers are still moving in the wrong direction, you can correct them at that point. And so that’s where someone on pizza or Chinese food, like, yeah, it’s a high dose up front and may manage it through the whole system. Or they may see an hour or two later, they’re still high and to take another dose, that they can bring it down at some point.

 

Stacey Simms  20:20

Alright, let’s talk about the big questions that people generally have. And that the one I hear the most is, Is it safe? Right? Is it? Is it okay to inhale this stuff into my lungs? Can you talk about the studies that you’ve done?

 

Mike Castagna  20:32

Yeah, I think if we were able to make inhaled insulin 100 years ago, we’d be scratching our heads those who would inject themselves three times a day. So I think it’s just an unfortunate matter of 100 years of difference. But we studied a phrase that probably over 3000 patients 70, some trials $3 billion over 20 years, like, that’s how much money time and energy is going into prove the safety and effectiveness of this product. And you know, and I tell people like you know, there is no data to say that it’s not safe. We have all the rodent studies, all the CT scans that along looking for fibrosis looking for pulmonary issues, we found nothing. So it doesn’t sit in the lung. There’s an old product called exubera on the market years ago. And exubera was a sugar based manatal formulation which got absorbed over time into your lungs in a friend this case, the it’s got water and human influence. So when we ask about what ingredients are you worried about the human influence, human influence, it’s the whole AI base, but it’s human influence characteristic, and water is purified. So we know that safe and the other only other carrier in our products SDK p which is a excluded product that is not metabolized in the body, it’s just 100% extruded. So you know, there’s three ingredients in our product. One is human insulin, one is water, and one is tkp. And SDK p comes out of the system. So I don’t I don’t think the body is afraid of human insulin. And what are so I think, you know, I always struggle with this topic. Because, you know, what happened is there was some lung cancer cases and Newser, were they there was a couple of our data. But you know, in the seven years since FDA approval, we’ve seen no safety signals come up in the postmarketing. We have almost 10,000 patients on the presidency. I know people in the drug for 1012 years. And so, you know, we don’t see anything that gives us concern. And we’re going into kids now, who would have to take the drug for 40 5060 years. So I think it’s hard to prove something that you’ve never seen. But safety comes with time. And I think the good news is product has been approved by the FDA for seven years now. And we’ve not seeing any safety signals in our database, which we look every year, our rems program ended early by the FDA and and we’ve continued to show good data and all the studies we’ve done, we’ve not seen anything new come up in our anywhere safety issues. So if you’re, you know, the populations, I would say if you have COPD, and asthma, this is not the right drug for you.

 

Stacey Simms  22:41

So a dumb question, though. If you have diabetes, and you smoke, can you get an Afrezza? prescription?

 

Mike Castagna  22:48

We would say you should not? Yes, we have a warning for that.

 

Stacey Simms  22:52

Well, I just wanted to be clear that there was an actual warning, it wasn’t just a please don’t because it’s bad for

 

Mike Castagna  22:57

warning. Don’t

 

Stacey Simms  23:00

tell me about the study with kids. Because I’ve got one, I’ve got a 16 year old who was quite interested in this product.

 

Mike Castagna  23:06

Yeah, no, I just found out Unfortunately, the dagga three year old cousin in the family have just come down with type one. And she will, she’ll be four and our studies gonna go down to four years old to 17 years old, when we launch it. So I’m excited, we had to do a study to show that the pharmacokinetics and dynamics of inhaled insulin are similar in kids as it as adults. And so once that study was complete, we we wrote a protocol down to the FDA and said, We’d like to go into the next phase, and now run a larger study head to head against the standard of care. And the FDA has pretty much signed off on that protocol at this point. And we have contracted with a third party to now run that trial. And we’ll be having our investigator meeting here in next month. And so hopefully, we’ll see our first patient in the four to 17 year old range, probably here in September, October time frame. So super excited, long time to get here took too long from my perspective, but can’t wait to help kids. But our founder Outman invested, he became very wealthy when he sold the insulin pump company. And he took $1 billion of his own money and made Afrezza inhaled insulin because he felt the problem with the injectable subcutaneous delivered insulin was it just took too long to work. And you know, somebody has an hour lag effects from food. That’s real timing, it’s always hard to catch those two even. And so he really wanted to make an inhaled insulin that really mimic a physiologic insulin that you see in the body. And he felt the only way you could get there was through a dry powder, lung delivered instantaneous insulin, you can also get there through an implantable pump. But that didn’t work out when they tried that back in the 90s. I recall. So people got infections and things like that. So that would that didn’t work. So they really were going to get a in my mind that physiologic inform that’s gonna be monomeric stabilized is probably going to happen only through the inhaled route. So we have we have to get comfortable with this from overall efficacy and safety. Otherwise, you’re not going to really ever get this control that people are looking for real time.

 

Stacey Simms  24:55

No man, he lived long enough to see Afrezza approved, didn’t he?

 

Mike Castagna  24:59

He’s All approved. And unfortunately, I’m here because he died on my daughter’s birthday. So I was debating whether to come to mankind or not. And I’m very superstitious, the Al Mann pick the day he died. And he died February 25 2016. And then they made decision to join and help save the company and save a frozen kick on the market. Because I think, you know, I saw all these wonderful patients stories online. And I said, these patients like Anthony Hightower is one of them, what they did something that no one else did, they did something we never did in our clinical trials. And so I got to talk to them. And I realized we just didn’t dose it properly. So you go back to the development of the product, a lot of the challenges were under dosing because everybody’s trying to compare one to one to injectable insulin, and therefore one of underdosing patients, and therefore, they got equal outcomes didn’t do any worse than injectable insulin per se. But could they have gotten better outcomes if we dosed improperly? Right? And I think that’s, that’s the state of we’re now trying to generate to show that the kids buddy now be head to head, or if he knows him properly, what happens? Right, and that’s we’re really focused on right now.

 

Stacey Simms  26:01

Is there anything that you wanted to talk about that I haven’t answered?

 

Mike Castagna  26:04

No. I mean, we’re only available in the US, we’re in the process of going to Europe. So I don’t know if you have any. Yeah, we do. Though, so I know, we have patients on a name patient basis in Germany, and UK and Italy. So you know, their governments are actually important a president and pay for it. We’re in the middle of filing for Australia. We were approved in Brazil, and we’re going to India so so you’ll see this more and more around the world. You have listeners in those markets. There’s not gonna happen this year. And hopefully, the next year or the following year in some of these markets, we’ll be looking at bringing it to more patients in those markets.

 

Stacey Simms  26:37

Well, and just got a big approval here in the United States for Medicare patients. Right.

 

Mike Castagna  26:42

Yeah. So that one, I, you know, we get a lot of questions on that one. And so you know, this market CGM patients were told you need to be injecting yourself, I think four times a day, we couldn’t get your CGM. So then doctors were not getting patients Afrezza. And so we were able to ask CMS to change that, and they did to the year but rather haven’t done they’re not done. And so here we are a year later that that policy is now being updated. I want to thank CMS and all that you’re helped make that happen. And I think it helps in people in CGN, because I understand that removes some of the other requirements to get CGM, even an injectable these patients so little mankind was the one who started that process. And then we’re able to help a lot more people. So it’s great. And we’re trying to get Medicare $30 a month insulin. So we have Medicare listeners. And you know, we’re trying to make sure we help get patients access that are on Medicare. I think that’s important.

 

Stacey Simms  27:33

That doesn’t stack up in terms of cost in the United States.

 

Mike Castagna  27:36

Yeah, I mean, you know, fortunately, the billion dollar debacle in this country is drug pricing, as we all know, and as a pharmacist, I know firsthand when people go through an LMS they’re on how many co pays are on. And so we really have tried hard to make sure that no patients pay no more than $15. So we have copay card programs, we actually have a free drug programs, they really can’t afford it, we’ll give it to you for free. If you’re going through the prior authorization process, we give it to you for free while you’re going through that. So we all want payers and reimbursement to be the excuse of why a patient can’t get access to our product, we think that people will do well on our product, we’re willing to take that bet that they’ll see good results. And if they see good results, the payers will usually pay for it. And it says you may or may not know that there’s a monopoly in diabetes between two insulin players, and three payers, who are all working together to make sure there’s no competition. You know, that’s unfortunate, but they pay to make sure that patients have a difficult time getting Afrezza . And that’s always one of my frustrations of competition or diseases. You know, 400 years, we’ve seen the precise the dispensing from 20 hours a while 95 and let’s say miles, hundreds of dollars. You know, for me on the payer side, we want to make sure patients we try to bring it down to about $15 on commercial and Medicare, you know, they generally pay comparable to what they would and some Medicare plans a little bit higher I can you know, that’s a hit or miss when you when you go to submit for reimbursement, but we try to do everything we can to make sure people will have access to our product

 

Stacey Simms  28:57

$15 for $15 for commercial patients, no, no, but what is it? What is it for? What do you get for $15? Is it a month? Is it a

 

Mike Castagna  29:05

my week? Yeah, whatever, whatever. You gave two boxes, three boxes, whatever is on that prescription for that month,

 

Stacey Simms  29:10

for the month. Okay, I didn’t mean to interrupt you.

 

Mike Castagna  29:12

I don’t think I know, I was gonna say I forgot we actually have a cash pay program. And people are paying cash for their insulin. And we do see several 1000 people a month paying cash for injectable insulin, we have influenced savings comm where it’s $99 a month for frezza. And you know, can you a bigger box or more doses, you might pay 199 but we tried to make the cash price, you know, roughly $100 a month. If we if you had no insurance, for example.

 

Stacey Simms  29:37

I’m not sure you can answer this question. But I will ask it anyway, is the biggest challenge for you all the failure of exubera? Is it just people not knowing what this is? You know, as you move forward, you know, what is the big challenge to get more people to adopt us?

 

Mike Castagna  29:51

I mean, for me, the biggest challenge are the doctors. We created a program we basically gave it for free to patients for two years for 15 bucks. Like no no priority. Nothing, we just charge you $15. And that didn’t change a lot of doctors from jumping on board. And doctors just don’t know our data. And so they think this product doesn’t have a lot of data behind it. And they don’t know our data, they don’t know. Like when I would ask a doctor, how fast from the time you inject your bolus, your pump to the time you look on a CGM, that your institute sugars are coming down, and I get in these endocrinologist, I’ll get five minutes and mediate and 20 minutes an hour, the answers, I need 90 minutes, 220 minutes, that’s the answer. And so they don’t even know the pharmacokinetics and pharmacodynamics differences between injectable insulin inhaled, and then you have doctors, right, you know, calling some of these ultra acting drugs faster, we’ll look at the package inserts, they’re no faster than their old products. And there’s a lot of misperceptions out there some of these newer launches of old tracking insulin, and to me they’re, they’re really not that much different than the predecessor and look at the data, you know, there’s not a faster, there’s not dramatically faster onset or offset or, you know, a one c lowering or weight gains on very much the same. So, no, I think it’s just a matter of doctors trying to really understand the data.

 

Stacey Simms  31:02

Before I let you go, are there any plans in the future to change anything about the way it looks? or different colors? I mean, I know it sounds kind of silly, when you’re just trying to get people to adopt the new technology, but from a user standpoint, and look, I know, you’ve heard all the jokes of my friends who use this will make you can’t comment on designers. They don’t say anything, they’ll make comments like, you know, taking a hit or whatever, right? I mean, it’s it’s inhaling, it’s this little thing that you’re, you’re inhaling, it looks a certain way. I’m curious if the cosmetics of it are anything that are on your radar, or needs to be improved even?

 

Mike Castagna  31:36

No, I mean, I think when you spend, you know, $3,000,000,000.20 years doing a new drug development or taking 100 year old product and reinventing it, you had to get that right in terms of device design and airflow dynamics and consistency. And those. And I think all that’s really important because, you know, misperception that oh, my God, it’s going to be less can be more variable than injectable insulin. And the data just doesn’t support that statement. And so for us, we have one of the world’s most unique installation platforms across the entire pharmaceutical industry, we deliver more power to the lung, the most technologies out there. So that’s why you can get consistency, those two those, and you don’t have a lot of variabilities, because our technology and our device is called a low velocity inhaler. And what that means is there’s a resistor that helps slow the powders as they’re coming out of the inhaler. So they get deep into the lungs. And that’s why you get that nice absorption curves that we see. And we’re most inhalers or high gloss inhalers. So it’s just enough sucking air as hard as you can, and hoping you get you know, 20 30% of lung drug into your lungs, and mostly stuck in your teeth to device in the back of your throat. That’s most dry powder inhaler technologies out there today. And so that’s something unique to us and our technology and our device, they all work really well together, you couldn’t just take our powder and put into another inhaler, and or just as well would not work. So yeah, we’re pretty happy with the device I we are going to other diseases. So you know, we’re we’re going down to the FDA with our partner for an approval in October for pulmonary hypertension patients. And we have several other orphan lung areas we’re going into to help more patients with lung disorders. So you know, I think that’s important, like our, our technology, our inhaler, our platform is gonna be used in more and more patients over the next decade than just diabetes.

 

Stacey Simms  33:13

Well, that’s what I was gonna ask is, if it works, so well, you know, will you partner with other medications? That’s great to hear.

 

Mike Castagna  33:18

Yeah, you know, we’re really busy, we probably have about 10 to 12 formulations of products working on this year and five marone products in the pipeline. And so it’s it’s a really good time of mankind, we’re super excited to be here. And it was a turnaround, the company struggled for many, many years. And we’re on our way to success. And I think, firstly, you’ll be you’ll be hearing more about it. So I know it’s been a long time. And maybe you didn’t talk to us yet. But hopefully you’ll talk to us more and more as we continue to generate new data and more more patients start using it.

 

Stacey Simms  33:45

I’d love to, I’d love to, especially with the kids programs. And like I said, I’ve got a 16 year old who is very curious about this. And, you know, once once safe and effective. Once we get all that safety stuff in here. It’s mom says, you know, I’ll definitely I know, I would like to check it out. So I really appreciate you coming on and spending so much time with me and my listeners and explaining all this and we’ll definitely talk again. Thanks, Mike.

 

You’re listening to Diabetes Connections with Stacey Simms.

More information at Diabetes connections.com. Always on the episode homepage. I also have a transcription as well, sometimes those podcast players don’t display the show notes and the links. So if you have any trouble, just go back to Diabetes connections.com. And I just want to say that I did reach out to have Mike or somebody from Afrezza on the show. And you heard him say, you know, it’s been a while, um, you know, it just took a while to connect to the right person. Let’s just say that, and I will have them back on because lots of good stuff is happening. As you heard.

I want to take a second and kind of explain Monomeric insulin and, you know, I’ll be honest with you. The scientific points here are really not my strong suit. I’m a communications major, right. So I did what I always do, and I am People who know a lot more than I do to help me explain it. I went to the Facebook group Diabetes Connections as a group. And you know, I said, How do you explain monomeric insulin I know it’s faster. And Tim Street, who is just wonderful and runs the diabettech.com page that’s like diabetes tech diabetic, and I’ll link that up as well. He provided this explanation, which really brought it home for me, and boy, I hope I’m pronouncing everything correctly.

So Tim wrote, insulin naturally links its chains together to form stable molecules. Typically it connects two together and then links three of those two chains together. Additionally, to create six This is highly stable and described as hexameric. In order to use these chains, you have to break the molecules apart to single chains, which are monomers. Typically fast acting insulins are stored as dimers, two monomers connected, which are easier to split, then hexamers. by storing the insulin as a single chain, a monomer, the body doesn’t have to break the chains to instantly use the insulin molecule it receives. And that is why Afreeza wraps the monomeric form in the capsules, to make it ultra fast.

Thank you, Tim, that actually made a lot of sense. I gotta tell you, we have the smartest people and the kindest people in this Facebook group. If you’re not there yet, and you want to join, come on in, I highly recommend it. You don’t have to be a Tim Street. You don’t have to be able to explain these concepts. You do have to be nice. And you do have to not post a lot of drama. I’m very tough on my diabetes groups. I run two of them. They’re very nice and friendly places for a reason. But Tim, seriously, thank you so much. That was a great explanation. And I really appreciate it.

Diabetes Connections is brought to you by Dexcom. If you’re a veteran, the Dexcom g six continuous glucose monitoring system is now available at VA pharmacies in the United States. Qualified veterans with type one and type two diabetes may be covered. Picking up your Dexcom supplies at the pharmacy may save you a lot of time to connect with your doctor for more info Dexcom even has a discussion guide you can bring with you get that guide and find out more about eligibility. It’s all@dexcom.com backslash veterans, and all the information is always at Diabetes connections.com.

Before I let you go, just a quick note about back to school, I have never done less. I packed up a bag for Benny to bring to the nurse. He brings his daily supplies with him every day in his backpack. But of course, like most people, our nurse has backup supplies for him. So I put those together. He brought them in along with our plan or orders, you know from our endo. And that was it. I haven’t set foot in the building. I’m not sure when I will go in or if I will go in probably when you forget something or they run out there. But I’ve never done less work. You know, I did a lot of work over the years to go to school and meet with people and he’s got it. So not much to report. It feels very strange. All right.

Please join me this Wednesday when we have our in the news live on Facebook every Wednesday at 430 and then we turn that into a podcast episode. I love doing that. It’s been a lot of fun. I hope you’re enjoying it. Give me your news tips. If you’ve got any from this week, just email me Stacey at Diabetes connections.com thanks as always to my editor John Bukenas from audio editing solutions. Thank you so much for listening. I’m Stacey Simms. I’ll see you back here in a couple of days until then be kind to yourself.

 

Benny  38:27

Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged

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