# 385 Gvoke HypoPen
Scott Benner
Gvoke is a premixed, prefilled, premeasured liquid glucagon that now comes in a HypoPen!
Ken Johnson is Senior Vice President, Clinical Development, Regulatory, Quality Assurance & Medical Affairs at Xeris. Ken is here to talk about the Gvoke HypoPen. Xeris makes Gvoke. The premixed, prefilled, premeasured liquid glucagon for treatment of very low blood sugar in adults and kids with type 1 diabetes ages two and above.
Jenny Smith is also here to help me answer questions about glucagon.
Learn more about Gvoke here
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DISCLAIMER: This text is the output of AI based transcribing from an audio recording. Although the transcription is largely accurate, in some cases it is incomplete or inaccurate due to inaudible passages or transcription errors and should not be treated as an authoritative record. Nothing that you read here constitutes advice medical or otherwise. Always consult with a healthcare professional before making changes to a healthcare plan.
Scott (1s): This episode of the Juicebox podcast is brought to you by GE Voke. The world's only liquid stable Glucagon G Volk is available in our, a prefilled syringe and in an incredibly convenient to carry it an easy to use HypoPen. As a matter of fact, I have a trainer of the HypoPen right here. Let me show you how easy does to use cap comes off. I find some skin press down
1 (28s): And it's done that.
Scott (30s): Yeah. Easy to administer glucagon. It's the easiest thing I've ever seen when it comes to Glucagon hands down. We're going to talk all about it today. How the G vote Glucagon came to be or what it is, and this brand new HypoPen, which is incredibly convenient to carry. And as you just heard, super simple to administer, anybody could do this in my opinion, before I start the show, let me say thank you. Because every question and this episode came directly from listeners to the podcast. So I really appreciate the effort and the thought that you guys put into those questions. And I hope you get your answers. I think you're going to today's episode is going to be a little different than most I'm interviewing to people today about Jeeva Glucagon first.
Scott (1m 16s): I'm not even first. Now here's the surprise. Let me just give you the surprise. Jenny is on this episode. Jenny Smith is here and I'm also speaking with Ken Johnson. Now Ken is a senior vice president of Clinical. Wow. This is quite a title at here. Ken Senior vice president Clinical Development Regulatory Quality Assurance that? Medical Affairs at Xeris pharmaceutical's Xeris makes Gvoke. Ken's got to answer all of your questions and Jenny is going to answer something to me.
1 (1m 45s): You guys,
Scott (1m 46s): You love Jenny. I love Johnny. How can we not love Jenny that's who else are you going to love? Ken Ken who buy the way has the secret talent. The man could play the piano, but not have to wait all the way to the end, to find out about that. Please remember that Nothing you hear on the Juicebox Podcast should be considered advice Medical or otherwise always consult a physician before making any changes to your health care plan or becoming Bold with Insulin
Scott (2m 38s): And there are two ways that you can request it through your doctor, either online or in person. If you have commercial insurance, you can request a prescription for Gvoke HypoPen right from the comfort of your home and have it delivered to your door fulfilled through PillPack by Amazon pharmacy. Just go to
Scott (3m 19s): We're going to start with Jenny Smith and then do a little Ken and then back too, a little Jenn. And Ken you got to get a nice rhythm going a little Jenny a little Ken is going to go just like that. I think you're going to enjoy it at the risk of repeating myself, because I say it in the episode, this is a leap for people who use Insulin making Glucagon liquid stable. It just This. If you don't understand why listen closely Jenny I already talked to Ken Johnson from Xeris pharmaceuticals about the Gvoke Glucagon and he's gonna be on the Show.
Scott (4m 7s): And just a minute, we talked a little bit just about what they were, you know, what they're trying to accomplish. I told him if the end of our conversation, that I'm incredibly excited about that company, like the ability to stabilize Glucagon in a liquid form, I think has other far reaching possibilities that I'm really excited about. But while I was talking to him, I got a it's a it's a, and can you tell if you can see this or not, but it's called their HypoPen and this is just a trainer, so it's not, it's not real, but you just pop off the cap and go like this and that's it. And it's over yet. And I was like, huh, well, that seems simple.
Scott (4m 47s): And I'm going to get one of those for Arden
Jenny Smith, CDE (4m 50s): Beyond simple. It's not scary
Scott (4m 52s): Exactly. Because you know, till this point in my life with type one, diabetes, glucagon has been a little bit of an, a, like a science experiment, but it was going to be an in a pressure situation. It's almost like someone saying to you here, do this while your driving a car, and there's a bear in the backseat, you know, you kind of felt like that to me the whole time. And, and they have their pre, they have their premixed syringes for emergencies to, which is just, you know, it's you just, it's in and push and you're done right yet. But, but still, and I'm, I'm going to ask you first, before I tell you what we do.
Scott (5m 35s): Do you carry Glucagon with you when you leave the house?
Jenny Smith, CDE (5m 40s): I don't carry Glucagon with me. If I'm just leaving the house for like going to the grocery store or going across the street to the park. No, don't I absolutely don't when we leave to go on even like a short weekend, two are in-laws or I go on, you know, to speak somewhere and whatnot. Yes. I, it with me now in that same case, though, if I'm carrying it with me in my pocket at a conference, somebody got to know what's in my pocket.
Scott (6m 9s): There's a lady on the floor. Hey, there's a science kit in your pants. What do you think? That's? What should we do? Where in the same boat, we don't carry it around like that either. If we're going to go too far away, or if it's going to be, if you're going to do at the beach or a trip, it comes with us. So here's my question. Would you carry this with you?
Jenny Smith, CDE (6m 28s): I would, because one, that's really easy to keep in my purse. And I mean, I've also, you know, knowing that I've got a son who'll be in second grade or something like this are easier to carry, I think, and from the standpoint of even teaching him visibly, there's no needle. I can easily say, Hey, pull this cap off, you know, stick it in my thigh, push it until it turns red and it clicks and it's done. I mean, that's it.
Scott (6m 58s): And it has these audio responses. I don't know if you can here the sec. So there's too, there's the push. And then the second one tells you your done. And I was like, huh, this I would put in Arden's bag. Like I really would. It's not going to scare somebody. And not only that, but if somebody opened this up a person who had no idea what they were doing, it's going to, you know, the packaging tells you what to do. And there's nothing about what I said to Ken when I was talking to him was I took this out of the mail, this trainer, and I handed it to my wife. And I said, I don't wanna tell you anything about it. See if you can make it work. And she did it right away, but it didn't take any like thought to do it's easy.
Ken Johnson (7m 39s): Hey Scott, this is Ken Johnson I'm with zeros pharmaceuticals. And I have a number of responsibilities that the company, including how we develop our drugs in the clinic and get them approved by the FDA. We also have medical team that supports ah, people with diabetes. And there are clinicians in the marketplace. And I also have a quality assurance team that makes sure that the drug's as we make them package them and ship them to pharmacy's and ultimately people and their homes meet the higher quality standards required for a prescription product. So all of those combined have been my responsibility at Xeris pharmaceuticals. For the past three years, I've been in this type of role for pharmaceutical development for a better part of 25 years.
Ken Johnson (8m 25s): I started out, I was trained as a pharmacist. I did research at the university of Colorado, whereas also involved in clinical research as a result of that clinical research. And I found my way into the pharmaceutical industry sector and had been there ever since. So that's a little bit about me. I'm I'm in Chicago where our headquarters are based and really happy to be with you today.
Scott (8m 47s): Thank you very much for doing this. I have a question about how you pull a team together for something like this. Does Paul know of you and com for you, or how does that work? Like how do you end up at Xeris?
Ken Johnson (9m 1s): Great question. So Polytech, our CEO, as someone who I met at the early part of my career. So 20 plus years ago, we were at a company based in Chicago called Searle pharmaceuticals. Paul was in charge of a number of commercial activities there and ultimately taking over some of the regional activities around the world, ah, for a number of our products. And I was his medical support. So a, you know, these things start early and have sort of an indelible effect. If these partnerships work and these collaborations work, you sort of maintain these relationships throughout your professional arc. We haven't always worked together, but oftentimes we'd been together out a couple other companies since that time. And most recently is he took the home at Cirrus who wanted to bring it together.
Ken Johnson (9m 44s): A group of folks that you felt could take us to the next level, get Gvoke HypoPen to market. And with that, he found me as well, a few others, we had this collective past together. So it's a little bit analogous to getting the band back together again. And we've, we've done that. And because of our past a familiarity success together, a what I think is an ease of collaboration, we do enjoy working together and I'm sure I'll do it again someday. Yeah.
Scott (10m 13s): How do you feel like The from the starting point to where you guys are right now, do you feel like that was on schedule went quicker than you anticipated? How much of that has to do with the, the, the, the, you know, the G Voke itself and how well it does, what it's, you know, what you're trying to, what you're trying to do.
Ken Johnson (10m 34s): Yeah. I think we encountered a situation where things were a little bit stalled or, or there's a few things that we had to take heat of that had been discovered before we arrived to make sure that we had, you know, a product that could meet all of the standards of the FDA. You could pass all the Clinical assessments. And so it really good foundation Scott, but it needed them and sort of to be rebooted to use that term it, and that meant conducting additional clinical studies further characterizing the product, making sure that we could put it into a prefilled syringe that's RPFs configuration or the HypoPen in the auto injector that was just released earlier this month. Right.
Ken Johnson (11m 15s): So that whole process of building, making testing, and then releasing brought together the team that you see today, you know, in fairness, there were about 12, 15 people at zero S when Paul took over and, you know, it's taken a lot of resources, people energy now in 200 plus employees later, you know, were on market with an approved product.
Scott (11m 40s): And for me to be sitting here holding this, this trainer pen, I guess it's a, it's a long time to get this into, get to this form and make sure it does what it says. So I think I want to understand what does it do because you've obviously come into a space where everyone has that red box and they genuinely think of it as something, you know, that they just have. They don't think much about it. I've been in that situation. My whole life. I get my daughter supplies, my daughter's supplies show up. They're there. I watch it until the expiration date and then I throw it away and I get another one. And I don't know that it's something that many people think about other than I know in the case of an emergency, you know, I've got this liquid in this powder and the syringe, and I'm supposed to mix them together and redraw them and use them.
Scott (12m 28s): And here's how, and ya know, and that kind of thing. And I have to train my school nurse to do it and, you know, My and her, grandma's got to know. So when she comes over, that's, that's, that's the narrative around that my whole life and for, for many, many people. So how do you improve on what's been going on for so long? Like what makes you feel like this is a great business and we should be doing that?
Ken Johnson (12m 52s): Well, I think, you know, just listening to your story and kind of the anxiety and complications that come with administering Glucagon for many, many years now, you know, going on in several decades of having the same configuration, it is a important pancreatic hormone Glucagon has very well known affects in terms of its ability to raise blood sugar. I think, you know, most days we're concerned about lowering blood sugar and insulin is critical, but, you know, think of this as the, the, the break where the accelerator, the, no, that the challenge is always been, it's a powder that requires reconstitution or, or, or put into a solution immediately at a time of use.
Ken Johnson (13m 37s): You can't do it early because it starts to break down very quickly. Most of the potency has lost or within 24 hours after mixing the powder for all these decades, that red box that you describe has been the single and only configuration available to people with diabetes are folks who would experience very low blood sugar. So our chief scientific officer took that on as a mission, you know, had his own personal experience and people in his life who said, you know, is it possible to overcome all those complicating, a multistep requirements of the lateralized Poudre in that vile? And he said, yeah, I think I can fix that. So it was his mission to make it a liquid, ready to use room, temperature, stable product, and to do that, we had to overcome the limitations of water and water is what you would use in the traditional kids to make it as a solution.
Ken Johnson (14m 29s): So we've taken water and replaced it with other a well known a solutions. Ours is called
Ken Johnson (15m 24s): And so you have basically a, a built in system to raise your blood glucose. And as such, we, you know, we wanted to just make the process of administering very approachable, very intuitive and not intimidating. And so we think we've accomplished that, but that was all only facilitated once we had a liquid version.
Scott (15m 44s): All right. After someone uses Gvoke what happens after is, are there side effects or are there things that happen afterwards? Am I going to feel nauseous? Do I have to go to the hospital? That's also, what's your dog's name, Bailey like that?
Ken Johnson (16m 0s): The question is, so I guess, I guess we'll have to give her a credit today. So a couple of things, I mean, you know, the effect that you do want is to raise a blood glucose, and that happens very quickly as we start to see changes in the blood glucose concentration within the first five minutes of administering the product is raised to what we consider a safe level of blood glucose very quickly on average, about 14, 15 minutes. And then the duration of action is probably about 90 minutes or so. So you have this ability to sort of bring yourself back up and then have it come back down, right? So it's a, it's a temporary fix two. What was a scary as hell? What can happen?
Ken Johnson (16m 40s): Glucagon has some other effects has some effects directly on the gastrointestinal tract. And so it at about 30% of the subjects that are trials has some nausea and about 10% handsome vomiting. So those are 10 or 15%, and those are kind of the hallmark features of what Glucagon does not matter what too, to anyone that sensitive to those GI side effects, importantly, they are transient. They are mild 80% of the people in our study and characterize them as mild. They went away and in our case, no one actually stopped being in our study because they had that, that known side effect that you would see that Scott with the old movie got, and you would see it with our Glucagon a you'll see it with future Glucagon so that we haven't mitigated.
Ken Johnson (17m 30s): It's probably dose-related. I think, you know, there will be a Day I hope someday where if we, you know, use different doses for different purposes, that we can mitigate some of that nausea, vomiting, but for the rescue one milligram setting of use your gonna have, in some cases, nausea and vomiting, then those side effects are
Scott (17m 50s): Side effects of Glucagon do not have a specific brand. It's just what happens during the process of bringing that low blood sugar up so quickly through Glucagon.
Ken Johnson (18m 0s): Yeah. And it may not even be read to get your rights. That's, that's the correct way to describe it in event, not even be related to the blood glucose, going back up as much as it is. There is a known, in fact that Glucagon to slow down the action of your GI tract so much. So that is completely different from what we're talking about today, but a radiologist will actually use this drug to stop someone's GI tract from moving, if they need to do procedures and other things. So now this is one of those situations where a bad thing for some person is a good thing for another, but it is important to let people know that there is some mild nausea in about 30% of people who use it for, for rescue.
Scott (18m 41s): Can you help me understand the different ways that I can administer as you vote when, you know, when you guys first came out and I became aware of You, my daughter switched too it, and she has the, the prefilled syringe, but now I'm holding. Like I said, This this dummy pen. That to me feels like I'm like what people would consider an epi pen and to be, I, I, I just push it down on my leg and hold it there for a second and, or a couple of seconds in, and I pulled away. Why do you have different versions? And can you tell me the difference between them?
Ken Johnson (19m 16s): Sure. The Glucagon it's the same for both a Gvoke PFS are people terrains in G Voke, HypoPen in the auto injector, you're holding a, in your hand. And so there's no difference. And that the active ingredient, the solution, the concentration is identical. It was a simpler and more straightforward manufacturing process to come to market with the prefilled syringe. It's less mechanical requirements because you, as a person, are the person helping you is actually going to do the injection much like you would self-inject or Jeff Insulin. Right? So it's a small subcutaneous injection, the necessary requirements to then put that into a device that fires itself, the auto injector, umm, it's more complicated, more engineering.
Ken Johnson (20m 7s): And we wanted to make sure we had sufficient quantity. So we come to market like we did the Smith and not having a sense of shortages or, or, or running out to be able to supply to market adequately. So, umm, there's a really, really high specification for performance of that auto injector because you're no longer responsible for pressing the plunger and the mechanics inside the auto injector. Our and so the FDA has carefully scrutinized the performance of this device and it has to work 99.99, 9% of the time. So that's a manufacturing spec and it came out of the experience that we've all had with epinephrin and HypoPen we want to make darn sure that if someone's going to pull that red cap off and press that yellow plunger, that if a fire's and so that took us a little more time.
Ken Johnson (20m 57s): Both were approved last September and in 2019, we could bring a prefilled syringe to market immediately and then to deal with all the issues that I just laid out. We just need a little more time and happy to release that now in July,
Scott (21m 12s): That's exciting. It really, it really is terrific. As I'm sitting here holding it, I mean the, the leap and leap really is the only word from what I'm accustomed to, to this it's it's like they're not even the same species in a, to B to be honest, it's a, it's a great, a great advancement. So I mean, whoever that guy is, you figured out how to make that, that liquid stable stuff is, is brilliant. Hey, have you ever used the Glucagon Isn't working on everything she's like, so the reason I asked is because while, while we were talking about this, he said, you know, we, we were talking about people administering it at themselves and I'm trying to think, I wish really trying to picture like, where's the tipping point where you're, it's gotta be, you know, it's not going to be one of those like, Oh, I got a little low, I need to eat something.
Scott (22m 10s): Obviously that's that's first, but there's probably a moment where you, I'm guessing, you know, imagine you're on a CGM and you see, you have double arrows down in your 50 a and you think, you know, you do the math real quick and you think, Oh my God, I gave myself too much. Insulin I can't catch this, do this like this. Right. Yeah. That made a lot of sense to me. I I've definitely been in situations where I thought, I don't know if I'm going to stop this with food and you know, and that's for Arden, but I really thinking about adults living by themselves. Okay. Can I have a question that I heard you say a second ago you were talking about self-injection and I think that there are many people who might assume that Glucagon has only for when you are having a seizure or an unconscious, but how would I self inject if I'm having a seizure or unconscious?
Scott (23m 4s): So obviously that's not the only time to use it with when are the times I'm supposed to be using this or, or I'm able to.
Ken Johnson (23m 11s): Yeah, I think that that's a great discussion. Thanks for raising that point. So I think, you know, there are a number of settings. Everybody has their own personal experience with what they deem very low blood sugar. I think you, in some of your colleagues have taught me this phrase, the, I don't know, low. Right? And so when that happens, it could be because you are looking at your numbers, it could be because you start to feel differently. And you know, some of the sort of classic signs and symptoms are, you are shaking. You're dizzy, you confused, maybe you haven't changed your personality or, or more combative, you know, trouble answering questions. Those sorts of things are all kind of hallmark sciences I'm going low.
Ken Johnson (23m 52s): So when that starts to happen, of course, the first rule of thumb is try to correct it with food or drink, right in your favorites. A source of glucose for many, many decades now has been referred to you as the 15, 15 rule, you know, take those 15 grams and the 15 minutes and see if it's work, if you're improving. So that's one situation maybe that isn't working and it's a stubborn lo and you know, you're starting to now wonder what's next. So that would be a time to consider administering Glucagon. And I think most people would not have reached some state of incapacitation where if they were familiar and able to a administered the auto injector where the prefilled syringe, they can, there are other settings where people are unwilling or unable to swallow or to have enough, you know, stuff available.
Ken Johnson (24m 43s): Maybe there a place where they don't even have access to a source of glucose. That would be another situation. If you feel like your passing out and there's somebody with you, obviously you'd want them to be able to administer it so that the community discussion, he should know the other people in your life, be familiar with where, with the gun it is and how to administer it. As you pointed out this HypoPen auto injector, it's a super intuitive and the instructions are printed, write on the pouch. And so I think if somebody found you and you said, you know what to use it, you know, it's going to be very straightforward process. We have tested that and found that in simulation exercises where someone is going through simulation or of an emergency in a very low blood sugar, they were able to administer correctly 99% of the time, follow the directions and do the two step process that you just talked about.
Scott (25m 34s): When the, when the trainer arrived at my house, I took it out of the packaging, took the instructions away from it. I handed it to my wife and said, I told her what it was. And I said, don't even think about it, try to use it. And it didn't take her 10 seconds to figure out what to do with it. And nobody here has ever used, you know, an epi pen or anything like that. So we've never held her or seen anything like this before. And I made me feel like, I hope my insurance company will cover a bunch of them or spread them all over. Arden was a college experience when she leaves for school. For me, I'll just, I'll just put one everywhere. It just really was intuitive. Is the word for it. It's you can't look at it and hold it and like eat.
Scott (26m 16s): There's no other thing to do with it. I don't know if that makes sense or not. You know what I mean? Like it feels like there's just one way to accomplish something and it, and it shows you that while you're holding it, like you said, it's in the instructions, but I'm seeing when you have the physical things in your hand, it's not like there's seven levers and you've got to decide which one it is. It only does one thing. And then, you know, if it does it well then perfect.
Ken Johnson (26m 37s): You know, I think, you know, that was part of the design, the understanding there's a whole area of science, human factors, research the services. How do we approach? So to solve a problem. And, you know, there's very, very intentional features built into that auto injector. The colors are intentional, the little window that you have that shows the liquid Glucagon, you know, in there. And it disappears. It turns red when the dos has been delivered, that's intentional. The clicks that you hear, those are intentional to let you know the sort of audio queue that the cycle it has been completed. We also have safety built in when you finish the injection and withdraw the plunger from the bare skin, it locks out.
Ken Johnson (27m 19s): And so you cannot have a needle stick because there is a needle inside the device, but it's, you know, never appears during the process of the injection. And when you're finished is locked out. So you can't have an accidental needle stick. Can I ask
Scott (27m 32s): Where can, can you just inject it? I mean, anywhere, like where has it, where did you, where were you able to get the FDA approval? And how do I remember that when I'm going low? Like, you know, or is it just anywhere I can get it into me is good.
Ken Johnson (27m 47s): And we, we concentrated on three areas, thigh, abdomen, and your upper arm. So we figured out, in most cases, one of those is going to be readily accessible. If you do have to have bare skin, because we want to make sure, you know, this is a 27 gauge needle. We want to make sure that there's nothing sort of inhibiting its path as it goes into the skin. But you know, we, in our assessment, Scott, most people opted for the abdomen. I think it was probably an easy to just pull your shirt up. And most people have an adequate real estate there. So, you know,
Scott (28m 20s): If I'm going to say I'm okay, I don't, I might all need Glucagon, but I'm a, but I definitely have a place to inject it. So,
Ken Johnson (28m 27s): So, so any, any of those three sites and it didn't matter, you know, the results, the clinical changes that we saw were the same, regardless of psych.
Scott (28m 35s): Well, that's even, that's very exciting because like I said, for people who know about older products, it's a, we were always taught, you know, deepest part of the buttocks, you know, like it's a, it's a big needle, you know, it's a, it's not an exciting, not an exciting endeavor for certain. So even that's a huge leap is my insurance got to pay for this. How do I, I mean, that, that's part of your purview, right? When you were talking earlier about what it is, you're a, you've done in the past. And so you, I'm assuming you have some background on this. You can talk about it a little bit. Yeah, I do.
Ken Johnson (29m 10s): If you know, and you never want to have a drug approved, but then not have any access for people. And so, you know, that's an important contribution that the company had to make in terms of going to insurance companies, going to pharmaceutical benefits management companies, you know, very close to the time of our approval last September and have these discussions about why it would be so critical to be able to offer this new a much easier, much more approachable version of Glucagon and the one they have been covering. So there wasn't any restriction on your Read KIS. And so we ask, can you give us the same treatment? And I'm happy to report as we sit here today for a commercially insured individuals, if you have unrestricted coverage at 87% of plans in the United States.
Ken Johnson (29m 54s): So almost 90%, wow. That, you know, why isn't it a hundred, there's no product that ever has a hundred. So there's always some small portion where there's going to be additional requirements. So that would mean that you would probably still have a copay and everybody's plans are different. These can be very, but you won't get one of these not covered types of messages. And the 87% of covered lives in the United States for commercial insurance. If you look at Medicare, probably the next biggest segment for people with diabetes, who should have Glucagon is about 80%. And then we're still working our way through the Medicaid requirements and were about four to 30% on Medicaid.
Ken Johnson (30m 37s): So if you know, for most folks, your not gonna have any significant access issues in terms of affordability, we are right now, if you go to glucagon.com, you can get all the details on a copay assistance program. And the net effect of that Scott is you would have a $0 out of pocket for the HypoPen for the, for the present time. So we're, we're starting out the launch of the product, offering that additional support, which means if you say had a $30 copay and you qualify it for the program, the company would subsidize at $30. He is essentially received it for free.
Scott (31m 15s): That's excellent. A great what was the,
Ken Johnson (31m 17s): The webinars Gvoke glucagon.com. It's GV. Okay. Now I've had a few people say, gosh, how do you pronounce that? But a GV. Okay, look again on.com.
Scott (31m 29s): Glucagon.com. I got it. And I'll put it in the show notes so people can find it too. So if someone's using a different Glucagon right now, and they've heard you on Thank I'm would like to try this, do they wait to their next appointment, go to their doctor and say, I want to switch my Glucagon are, or what are the pathways to making the change?
Ken Johnson (31m 49s): Yeah, I think any of those might work. I think traditionally, when we need something new, we would contact her in health care provider and se there's a new Glucagon and it's called Gvoke HypoPen. Can you send me a prescription for that? Can I get a film, our experience with clinicians if they are pretty well aware now, but this is a configuration that's on the market. We've been working hard with a professional society's and through their channels to make sure that they know that as a personal Diabetes requested that they would, you know, no of it and not be afraid to read the prescription because have the access issues. Now you have also been cleared that makes it very easy for them. So it's not very cumbersome if you don't want to pursue it that way and just make a call to the doctor's office, usually does not require a visit.
Ken Johnson (32m 34s): Scott it's just a, you know, a new script is an issue from the electronic system. You can pick it up. That's your favorite pharmacy. You can also go to the website and we've set up some services. They're a little bit more analogous to kind of ordering online and you can enter some personal information or information about your doctor. And we have support services available now through pill pack and Amazon company that will work with your doctor in deliver it to your home at no cost.
Scott (33m 5s): I'm not sure I heard you, right. Is it PillPack?
Ken Johnson (33m 8s): Yeah. So the Jenny that helps assist in sort of the transactional part of this is PillPack. It's an animal Amazon company. A but the easiest thing to do is to go to
Scott (33m 50s): Right? So if someone listening just feels that economically they can't do this, they should be able to and contacting you is the way to go.
Ken Johnson (34m 1s): It is. And I think Listen, there are, there could always be some leg and whether or not the coverage policy has caught up and maybe their getting a strange answer about how much their out-of-pocket would be and things like that. We have a whole assistance program in place to help navigate that. We know how frustrating that is, you know, we wanted to make Glucagon easy to use, and now we want to make getting a prescription filled, easy to do. So, you know, we have very, a nice set of services that are linked to the website. There's also a phone number at the website. And in case it's easier just to call and talk to a real human, but you know, that takes you through a whole tiered process of, you know, is it going to be covered?
Ken Johnson (34m 42s): You know, what pharmacies have it and so on and then write down to even, so the patient assistance programs for folks who can't afford their medication,
Scott (34m 53s): The concept of having to mix Glucagon stopped us from using Glucagon when Arden was legitimately having a seizure. I just don't know that. I mean, you know, technology's better now, obviously, and that's great, but I don't see, I can't imagine going backwards on this one, like this to me seems like the best it's available. Right. I was wondering, do you hear from people about mixing and what did they, what are the responses? Do you think that that having to mix the Glucagon stops people from even considering it as an option? Sometimes
Ken Johnson (35m 33s): I think given that that was all of that, there was all that was available
Jenny Smith, CDE (35m 39s): For such a long time. I mean, you know, again, thankfully my parents never had to deal with that. They never had to mix it. They never had two. It was always there. He always knew where it was in the house, but I, I would say that it's certainly a deterrent to use because it's, there are just the extra steps, again, as you brought up in your situation, it's like having to think through those steps when you got your loved one, either having a seizure or you've discovered them completely like not with it at all out, can't talk to them, whatever your brain is thinking in terms of helping them.
Jenny Smith, CDE (36m 24s): Yes. But all the steps of mixing, making sure it was mixed right now, you've got in the needle on that. I mean, this is scary looking needle, compare it to a syringe needle for Insulin. It is, it's a bigger needle, right? So, you know, imagine putting that into your two year old or even your 12 year old child and knowing that you're doing it the right way. And I can say that it would be a it's a deterrent, although I dunno, in the case of not having anything else as an option, you figure it out, but it's certainly going to be,
Scott (36m 58s): Well, I have a friend who recently had a teenage son, a have a seizure and she got the red box out. She got it mixed. And when she went to draw it back out, like in the, what your describing, running upstairs, people yelling, she broke the needle off in that crazy. So they had to go to a secondary option, but they were getting ready to use it. And she, she was trying to traverse there's and mixed Glucagon at the same time she was running to where it was happening, you know? And I think, I just think that that's the point, is that anything that simplifies that is genius and putting it in, you know, what can be described to people who don't know any different?
Scott (37m 44s): Is it as an epi pen style? Like just this thing in your hand that you just push down and hold this, turns it into something people can carry with them.
Jenny Smith, CDE (37m 52s): Absolutely. I even think two from a school type setting, even the comfort level of, let's say for some reason, you know, technology is down your not able to contact the parent. You don't know exactly what to do. I mean, from the standpoint of safety and feeling okay, and teachers or the Peros or whoever's helping at school, this is a hundred percent easier.
Scott (38m 17s): I think this takes away from that thing that a lot of people who aren't, who know, who have kids know, you go to school and you're like, I need somebody to be a Glucagon advocate from my kid. And everybody's like, no, thank you. You know? Like, like they really do too, like teachers, or like, I don't want to be on the hook for this, but, but this is like, again, I think this takes away the possibility that they can make a misstep in the middle, like drunk when Arden was a little, her, her directions were drawn up half the vile. You should have saw the fear that put on someone's face. Well, how do I measure half of the vile? I'm like, I don't know. I bought it. And they're like, what? I'm like, Oh, here we go. This is fine. After I get either the prefilled syringe or the HypoPen, how long do they last until they need to be replaced?
Ken Johnson (39m 4s): Yeah, that was part of our design criteria. We didn't just want to make a liquid ready to use if you wanted to make sure it could last a long time because you know, hopefully once or twice a year event and most, and even if it's a never event, you know, let's do not have to replace it too often. So right now, from the time of manufacture to the end of life or a potency, a sufficient for a re restarting, the blood glucose it's two years, but it's a very long shelf life. You know, we, again, you know, that was part of the design process and certification process and approval with the FDA that we have a two year from time to a manufacturer expiration.
Ken Johnson (39m 46s): So that'd be printed on that other product. You'll know when it expires a number of pharmacies. Now you can have reminder programs. So, you know, it's time to get at all.
Scott (39m 54s): Can I have to tell you? And I genuinely mean this. I've spoken to a lot of people who work for peop you know, manufacturers of different drugs and devices, and that's the first time anyone's ever said anything to me that almost knocked me off of my chair. I just took two years. Is it's amazing. And not what I expected you to say. That's because what I was going to say is, you know, we got the prefilled syringe, and I had a question about that actually, before I go down my story, we got the prefilled syringe and it comes in sort of a pillow bag is my best description of it. And my first thought was, huh, there's a needle in there. And this is sort of a bag. And then when I reached out to the people who are listening to the podcast, that was actually a question they had was, you know, why does the like, explain to me why the, the needle is safe in this bag?
Scott (40m 41s): And I guess, I guess thinking couldn't it be deployed, but to answer that for me first, obviously you didn't make something and not think, Oh, I wonder, you know, I'm assuming it's been tested, but explain to me how you came to the, the packaging for the prefilled syringe.
Ken Johnson (40m 56s): Yeah. It serves to a number of purposes. The packaging is a sealed foil pouch. Its done a very, a controlled environment. The prefilled syringe that if you describe Scott actually has a noodle shield on it and also has a backstop to keep the plunger from being deployed. So why a pouch? I think you started with that question. So first of all, the instructions are printed on the pouch and we want to make sure because you know, the real estate on a, on a prefilled syringe where the real estate and the auto injector is not sufficient to describe how to use it. It would be six point font and we wouldn't be able to read it. We have these very clear pictures and words printed right on a pouch that could tell anyone how to use it.
Ken Johnson (41m 42s): In fact, we tested that we have people who are untrained in the administration of the prefilled syringe and the auto injector and they successfully administered it. You know, like I said before, 99% of the time. So the second is that foil and the gas that we pack it in inside there. Cause you notice its like a pillow because its actually has a pressurized it's in there helps with and moisture because those are the enemies of any drunk. It doesn't matter if it's Glucagon or anything else sort of protecting it from light and moisture helps contribute to that two year shelf life. So we, we can't stress enough that you should keep it in these pouches until the time you use what people are.
Ken Johnson (42m 25s): You know, people may say, well, it's, here's how I know what to do. What's inside the pouch. So that's why we've provided videos. That's how it could be provided the demonstration units. Like the, when you have, you know, they'll be available in the clinics. Doctors have been requesting those demonstration units. So if there should be no mystery about what's inside the pouch, but we do acid if he started in that until the time of use and it's, you know, so multifold purposes for having that pouch
Scott (42m 52s): Is it all makes sense. It just, and had, I probably thought about it longer, you know, what it really is is that it was just different and so than what I was accustomed to. So when I saw it different felt wrong and now you explain it to me and like, Oh, well different seems like more well thought out in a new and better. So a that's excellent. Can I give you
Ken Johnson (43m 11s): If you want to anecdote as we were testing that power and sort of the size of it and how big the print was and everything else, we've had a number of Diabetes educators as a part of our forum for focus groups. And there was some that wanted it even bigger because they wanted to write all kinds of instructions and the margins and the doctor's phone number and you know, reminders about other things and stuff. That's like at some point we had to say, no, you know, we can't add to it, this giant pouch, it's gotta be small enough and portable enough. So, so, you know, there, there were a few rounds of the things that, you know, let us to the current configuration,
Scott (43m 41s): If they did, they have it up to the size where you could put three holes in it and people get carried around in their binders.
Ken Johnson (43m 47s): They're, you know, so, so know is all intentional and a contributes to the, the long shelf life. It contributes to the successfully administering it and at the time of emergency and it also protects the product
Scott (44m 1s): Going back to the beginning of this thought for me, what I was getting ready to say, when I asked you how long does the product last before it needs to be replaced? What I was gonna say as I think I'm going to get to move on to the HypoPen afterwards, because I can see how, you know, it's just, it would just make, I think this would be easy to show my daughter and say, look, if you really feel like you're in trouble, do this. And it wouldn't feel like, you know, a rigmarole I guess, and, and, and maybe off putting in any way. And so I thought I'll switch, but now I realize I've gotta wait two years. I switched. So a, I M
Ken Johnson (44m 34s): You bet you brought up another issue and that is keep people, staged them at different parts of their daily life. Right? If you keep the prefilled syringe and the nightstand at home, you might have the auto injector at school or with the coaches or wherever. So, I mean, you know, mix and match again. There's no difference that in the Glucagon is contained any of their device for the product.
Scott (44m 55s): No, no, no. I, I, and I, I guess I was half kidding, but I do know that, you know, there are different Podcasts if our kids ever grow back to school, she'll need one for school in, in a couple of other places. And it just, you know, I can't, I can't say it enough, it's the, it's easy to have you on the show and talk about it. Because like I said, this is a leap and this is going to make people's lives. I think easier if they should ever have an emergency and need to use it. And I think the comfort they're going to get from it, just having it around Is is going to be different. I, you know, I really don't mean to pile on somebody, but that, that red box is not comforting. It's off putting, and this, this thing I'm holding this pen here is comforting. So there's a lot to that.
Scott (45m 35s): There's a lot to the psychological, the psychological side of all this. And I appreciate that. That was considered,
Ken Johnson (45m 42s): You know, we've talked with folks sort of who lived through all of this and seeing the changes in technology and new delivery. Insulin certainly advanced and the bringing forward CGM pumps are, you know, all these things have been stepwise improvements. Glucagon just, wasn't tackled. And, and, and now that we have, you know, we want to keep making improvements and exploring other other uses for it and beyond the, the, the currently approved one. And so the companies, you know, vested in making the most of a liquid ready to use Glucagon. And so, you know, stay tuned for more. Now
Scott (46m 20s): That as I was jumping on this call, I got a message from somebody. It was so funny. They don't know the timing of my schedule, but they just were like, if you, if you haven't spoken to the people at chief Oak, yeah. Can you please ask, is there a water and Insulin and if there's water and insulin can, can, Insulin be made more stable with their technology. And I was like, I dunno, I'll find out. So I, maybe my bigger question is, are there other things your stabilizing over there, or, or you just the Glucagon company, or is there more,
Ken Johnson (46m 54s): You know, we are more than a, Glucagon a company. So at our core, we want to take the technology to make liquid ready, to use easily injectable, very stable products and all of the areas where it makes sense. We have talked about it Insulin and it's a, it is a project and it's not anything that's a, you know, advanced in terms of it's Clinical Development. But we do recognize that there are limitations on the storage conditions for Insulin or other things that it can be mixed with cost problems. So maybe we can start to combine it with other effective, low blood glucose agents and make a better combination. So, umm, the, the short answer is yes, we can apply our technology to a broad range of drugs, proteins, monoclonal, antibodies, vaccines.
Ken Johnson (47m 42s): And so, you know, that's, our mission is to take all of the concern and the difficulties of administering and storing and drug out of the equation. And so that's, that's kind of the, the future state of zero S and, and how we'll apply ourselves. But you know, us now as the blue thing, as a company first and foremost, and a, you know, and we'll use that as a starting point and grow from there,
Scott (48m 5s): Your technology applies to a lot of other things. So they're, there are probably many things that we can't talk about that are being considered there. And I'm asking that question as a wink and a nod to all the people who asked me questions that are not covered by your FDA approval. So I can't ask you here, but they'll all understand where they hear this and be excited that you're working on other things I think is that fair?
Ken Johnson (48m 28s): Oh, that's definitely fair. And our company website to a separate from a DeVos glucagon.com describes some of our pipeline and the things that are still in an experimental phase. And you'll see that it's, Glucagon, it's a drug called die as a pan for seizures in other programs. So we're, you know, we're, we're really interested in applying this technology broadly and solving problems for patients and their providers,
Scott (48m 55s): If it's possible that I'll ever be able to get G Voke in a vial for home use to just keep and administer as I need
Ken Johnson (49m 4s): What we would like to pursue that. Yes, I think, you know, there are a number of applications of Glucagon that are different than our are approved used today. It's a one milligram, you deliver the whole dose, a in the setting of restoring very low blood sugar, but there are other settings where maybe the smaller dose would be useful. And, and so there or other settings, whether it's exercise, whether it's hypoglycemia, unawareness, other things were, there are a series of, you know, Clinical Development projects that we've sponsored. We've collaborated with one side as well as a part of a dual hormone delivery with Insulin and Glucagon as part of a closed loop system.
Ken Johnson (49m 45s): So in a, none of these are approved, none of them are a possible with the current configuration. We would need a vile of Glucagon as you describe the Scott. So it'd be very similar to how you would administer Insulin. He would have personalized doses for the situation that your trying to manage. So that's gonna take us some time, but we are investing in those efforts, you know, just ask everybody to stay tuned for more.
Scott (50m 10s): All right, well, I'll say this from my heart and many people may or may not understand this. And I guess if you've been around Diabetes long enough, if it makes sense, but it may not seem super exciting that someone figured out a way to make Glucagon liquid stable, but is super exciting and that it opens many doorways and possibilities for the future. Everyone who has someone that they love with type one diabetes or has type one diabetes, should be incredibly jacked up and excited that you guys figured this out. And I know that it, it's hard to wrap your head around why this is that exciting, but it is. And I'm, I'm very much looking forward to what happens next. So I really appreciate you coming on and explaining all of this.
Scott (50m 52s): And I thank you for your time, unless you want to play some piano. I think we're good.
Ken Johnson (50m 57s): My pleasure. Scott I enjoyed it and hopefully we can do it again sometime. And my best to Bailey you left the room,
Scott (51m 8s): Dammit, cameo bark. So you'll have to cut that part. So I thought I could get a little park at the end and we'd be finished anyway. Thanks so much. Enjoy the rest of your day. Really appreciate your time. All right. Appreciate it by huge. Thanks to G vote for sponsoring this episode and for giving me the opportunity to just speak with Ken and a huge thank you to Jenny Smith for being such a good friend and coming on the show to talk about Gvoke. If you'd like to find out more about you Vogue, there are links right here in the show notes of your podcast player@juiceboxpodcast.com or you can just type the words
Scott (52m 1s): I have a little bonus stuff here at the end for you. If you'd like to keep listening, I actually spoke to Ken the day before we recorded this just for a few minutes, so we could get to know each other. And he told me about his piano playing. So I brought it up at the beginning of this recording while we were getting the audio set up. So it was recorded, but not really a part of the episode, but I left it here. Cause it's interesting. What kind of music do you apply? So,
Ken Johnson (52m 28s): Oh, I'm like what they prefer to, I guess, as a professional journeymen, sidemen I'll play whatever, whatever comes on my way, I read music, you know, I play from classical to jazz, to tribute acts, including pink Floyd and van Morrison and a REIT, the Franklin and two classic wedding bans. You know, the most cliche kind of lounge music. You can imagine it doesn't really matter a musical theater,
Scott (52m 55s): The multiple instruments or not.
Ken Johnson (52m 58s): I'm a piano player, keyboard player.
Scott (52m 59s): That's really, that's an amazing skill to have. That is very cool. And it's great that you get to do it too.
Ken Johnson (53m 5s): Yeah. So Chicago, you know, traditionally has been famous for lots and lots of live music. And of course, many famous bands have come outta here, but we're a complete shutdown now. It's just awful.
Scott (53m 18s): And online really doesn't replicate it. There's been, I think one or two people who have done it well, you know, and it's, you know, you have to, you can see how much money you have to have a, in a crazy example is that, I don't know if you saw, you may not like this kind of music, but maybe you do. You mentioned pink. Floyd Metallica did an old song acoustically remotely. So all four guys were in a different place, but it sounds like it was recorded in a studio. So you have to assume that each one of them has a professional recording studio in their home, you know, but that worked out, but,
Ken Johnson (53m 51s): And that's exactly how they do it. And what we are led to understand as consumers is they record all those tracks independent of each other, and then somebody who mixes them because you can't, you can't use zoom to have simultaneous music because whoever's talking to the loudest takes over the channel. And so there's, there's no mixing up on zoom. It's a, it's a big problem.
Scott (54m 12s): You know, all that equipment and the willingness to spend a couple of million dollars to mix a song together to release it. And they had that money and they did it. And everyone else is just like you said, fumbling through trying to do in a resume for those of you who are not familiar with a podcast and don't know who Jenny Smith Is I thought I'd take a second to let you know Jenny is a frequent guest of the show. She's helped me put together series within the Podcast like defining Diabetes, ask Scott and Jenny. And of course, the very popular Diabetes pro tip episodes and of all of the people I could have had on those episodes with me. Here's why I picked Jenny. Jennifer Smith has had type one diabetes for over 30 years since she was a child.
Scott (54m 53s): She holds a bachelor's degree in human nutrition and biology from the university of Wisconsin. She is a registered and licensed dietician, a certified diabetes educator, and a certified trainer on most makes and models of insulin pumps and continuous glucose monitoring systems. I love Jenny. She is a friend. And when I decided to do this episode, I asked her if she could help out a little bit and she was very gracious and said, yes, Jenny works, has integrated Diabetes so you can check her out. If you do, like@integrateddiabetes.com.
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