Originally posted on Beyond Type 1
For people living with diabetes, glucagon can literally be a lifesaver. In the currently available formulation, the medication requires reconstitution — as glucagon is unstable in liquid form. Xeris Pharmaceuticals is looking to change all that with their developmental glucagon pen. When the company announced the appointment of Paul Edick as President and CEO in January 2017, it was clear how serious they were about bringing liquid stable glucagon to market. Edick has 40 years of experience in the pharmaceutical industry, and recently spoke to Beyond Type 1 about the history of Xeris, his personal experiences with the company, and the future of glucagon.
Can you tell me about the history of Xeris?
The company started as an idea of our Chief Scientific Officer, Steven Prestrelski. He’s an outstanding scientist, and he developed a methodology for making products that are unstable in solutions stable, and products that are not soluble soluble. He formed the company around that chemistry in 2005, and then it progressed slowly over the next decade. It was funded a little bit at a time, initially by friends and family and then some serious investors. In 2016, the investors approached me to take over the company. I laid out a strategy for the company that was about getting the glucagon device to the market first, but also about moving into other uses of glucagon. A liquid stable glucagon would open up a world of opportunity in terms of other ways to help patients.
Our mission internally is building a great company that we can be proud of. Externally, it’s building a company that services patients in a way where we can change medicine and improve the lives of patients, not just provide the next better drug. I believe being able to change medicine has a value proposition that’s beyond just the individual patient.
What lessons learned from your four decades of working in the pharmaceutical industry have you brought to Xeris?
The things that have been most important in my experience are those things that change medical practice or change the lives of patients. When you can do one of those, that’s incredibly rewarding and when you can do both, you end up with a very successful company. We focus a tremendous amount of energy on how we do what we do — the behaviors that we employ as a company and as individuals in order to accomplish those first two things — bringing change to medicine and improving the lives of patients. That is also how we build our culture, which is all about the people, the way we work together and the way we work with our customers. Over those 40 years, I’ve learned a great deal about how to get people focused, energized and motivated and to pay less attention to bureaucracy and process and politics. When you’re building something, you want people to be able to look back years down the road and say, “Wow, look what we did.”
Can you explain the reasoning for the liquid stable glucagon being the first product that you decided to bring to market?
It was the furthest along, and we believed it had the greatest immediate potential for changing the lives of patients and changing medicine. In my mind, it was clearly the thing we had to prioritize, and we have. We’ve finished all the clinical studies, and the stability program. That product is currently in front of the FDA. When you talk to Type 1 diabetics who have low lows on a regular basis, the fear of going too low without something to counter that situation is a huge unmet need in the marketplace. There are 3.5-4 million people who the American Diabetes Association (ADA) say should have glucagon handy just in case. However, there are only 660,000 filled prescriptions a year. Less than 20 percent of the people who should have glucagon handy actually have it. Having something that patients could even self-administer at a moment of low, low blood sugar that is on the verge of crisis, can potentially change their lives. That means a lot when you’re building a small company to be able to do that.
When do you anticipate the Xeris glucagon pen to be commercially available?
We hope to have product available for the back-to-school period 2019.
What are some of the other potential uses for liquid stable glucagon?
The next most important priority for us is to get a vial of liquid glucagon to the market for self-administration. The two most important areas that we’ve identified; one is a non-diabetic population called post-bariatric hypoglycemia. These are individuals who have had bariatric surgery to try to treat obesity and two to three years after surgery, a small percentage of them begin to experience very severe sudden hypoglycemia, post-meal. The exact cause isn’t known other than that the surgery has changed their physiology, We have ongoing clinical studies where we are looking at whether giving a small amount of glucagon, so a lot smaller amount than what you have in the rescue device like 150 micrograms, 150 to 300 micrograms within about a half an hour to an hour after a meal you can prevent the severe hypoglycemia. This would be potentially life-changing for some of these patients who are not diabetics and are thus not used to managing their meal in that manner.
The other potential use is exercise-induced hypoglycemia. You’ve got a million and a half people living with Type 1 diabetes, many of whom exercise or play sports. The extent to which you have to plan, reduce your insulin, and eat carbs while you’re exercising makes exercise and physical activity cumbersome. We’ve done studies and we have data that once again, with a micro, mini-dose of liquid stable glucagon five minutes before you want to go run a 5K, your glucose is going to remain stable. If you think about it, having a vial available to administer before a soccer game, or run a 5K, would be once again potentially life-changing for a lot of Type 1s – and adolescent Type 2s who are involved in sports – big time.
Cost and access remain major concerns in the diabetes community. Will the Xeris glucagon pen be available to everybody who needs it?
We’re generally asked whether we’re going to charge a premium price for our product simply because it’ll be a ready and easy to use when needed, and my short answer is typically: No. And because we, like the diabetes community, recognize that cost and access are key concerns that we’ll likely have parity pricing to what a patient is paying for the Lilly emergency kit today. Look we’ve been talking to payers and the unanimous feedback we’re getting is, “If you’re not premium pricing, then we’ll put you on pretty quickly because it’s a better product, we’re already reimbursing it, and it’s a rescue product.” This means that for most people with diabetes who have insurance of some kind, it should be available at a reasonable low co-pay, quickly after approval.
You know, it typically takes a few months post-approval for all the payers to complete their formulary process. Knowing this, we will do the same with Medicaid, where coverage is done on a state-by-state basis and, frankly, we’ll be as aggressive as we can and do that as fast as we can to garner access. With Medicare, coverage just takes time but we’re working to ensure we’re complying and accelerating those timeframes. Then of course you’ve got patients with no insurance, and we’ll put a program in place to be able to address that as best as possible. Hopefully it will be a simple, efficient process to try to make getting our pen accessible to the largest percentage of the diabetes community.
What are you excited about for the future of Xeris?
In addition to our glucagon, Xeris is working on a pramlintide-insulin combination therapy. Pramlintide was brought to the market to help make mealtime insulin work better, however because of the sheer logistics of doing all those injections and the titration necessary, it really didn’t do that well in the marketplace, although it had great promise for patients. With our technology we’re able to formulate a stable liquid version and we’re also able to formulate a more stable insulin because we highly concentrate both products in our processending up with a more stable pramlintide and a more stable insulin so allowing them to be put together at a fixed ratio at different doses. What we have shown in the pre-clinical studies in animals is that we’re able to use less insulin, get a better effect and show a glycemic control or glucose flattening out for at least as long as originally intended and possibly longer in the post-meal period.
What else should people know about the Xeris glucagon pen?
What we hear a lot is, “It’s not going to happen to me.” I think that is very reasonable. We are developing a product that is “just in case”. We want to see people have fewer situations where they have to call 911, have to go to the emergency room, or have to have somebody try to help them. At the end of the day, our goal is to make sure that the community at large is better able to manage their diabetes.
This article was published as part of a partnership between Beyond Type 1 and Xeris.