The Future of Glucagon with Xeris Pharmaceuticals CEO Paul Edick


 

Paul Edick serves as the Chairman and CEO for Xeris Pharmaceuticals, Inc., makers of the Gvoke Hypopen® and Gvoke® PFS (pre-filled syringe). Beyond Type 1 recently sat down with Paul to discuss the availability of their ready-to-use glucagon products, how the company was affected by the COVID-19 pandemic, and what their plans are for the future. This article was made possible with support from Xeris Pharmaceuticals, Inc. Beyond Type 1 maintains full editorial control of all content published on our platforms.


 

Beyond Type 1: Thanks for speaking with us today Paul. How have things changed for Xeris since we last spoke in 2019?

Paul Edick:  Thanks for having me, and to answer your question: A lot has changed. Both Gvoke® PFS (pre-filled syringe) and HypoPen® were approved in September of 2019. We launched the pre-filled syringe right at the end of the year, and HypoPen in July 2020.

By the time we did launch Gvoke HypoPen®, we had a $0 copay in place. So almost everyone with commercial insurance would get it for zero dollars and they do still today. We put 5000 Pre-Filled Syringe units out as free units into doctor’s offices, and a lot of them have been used as rescue devices in offices.

How did the Covid-19 Pandemic impact Xeris?

It’s been tough. The entire healthcare world has been impacted. In the first half of March 2020, it was pretty clear that things were going to shut down. I was on the road and actually called the office and said, “Okay, pull everybody from the field.” And that weekend we instituted a totally virtual platform for the salesforce so that the next week they were all starting to be trained on the rep emails and video calls and you name it — whatever virtual tool we had.

And things have been mostly virtual since. Just recently we’ve got reps that are starting to get back out in the field. We grew Gvoke® throughout that period, which is a minor miracle. We have people back in the office. During the pandemic, we instituted an inside sales organization that is just calling doctors and emailing. So we’ve tried to be very innovative in order to get Gvoke into the hands of more people who are at risk.

Was the manufacturing affected at all?

Luckily the manufacturing was not affected by the pandemic. We were concerned early on for Gvoke HypoPen because the parts are manufactured in Taiwan, but they didn’t have a work stoppage. If there had been, it would have delayed the launch. The Pre-filled Syringe is made here in the States and has had no disruptions. We’re lucky.

Why did you decide to make Gvoke virtually free with a $0 copay card? How long will that program last for?

With the pandemic, it became very, very clear that this is a population that is at increased risk. Unemployment started to skyrocket. People are cutting back on their insulin in order to be able to pay for their insulin. There are 6.8 million people on insulin. Only 10% of them actually have glucagon of any variety. So the pandemic came about right in the middle of trying to get millions of people to actually go get glucagon so that they have it.

The pandemic affected everybody economically. It affected everybody in terms of their ability to go to a pharmacy. So we almost immediately went to the $0 copay in order to make it more accessible and we’ve kept it that way. And we’re still not out of this pandemic. The world is behaving like it’s behind us. It isn’t behind us yet. I can’t say for sure how long we will maintain that, but we haven’t made a decision to stop.

One more thing we haven’t really cracked yet: What physicians should be doing is when they write a prescription for insulin, they should also write a prescription for glucagon. Hopefully Gvoke, but at least one form of glucagon, and we haven’t had that yet. It’s not happening. So anything we can do to encourage physicians to do it and patients to ask for it, we’re going to do.

We know glucagon use is less common among those with Type 2 Diabetes. How have you focused on the Type 2 community as well as the Type 1 community?

There are no degrees of risk when it comes to severe hypoglycemia. It could put you in a coma or potentially cause you to lose your life. Those are facts. And whether you’re a Type 1 or Type 2, you don’t know when, and  often you don’t know why.

So, our message is: If you are on insulin, or if you’re a prescriber of insulin, there should be a co-prescription of glucagon because you’re at risk for severe hypo that could be life-threatening.

And we hope that message gets across. We think Gvoke HypoPen is the easiest, simplest way to resolve that and these new ready to use products bring self-administration into the equation. That is a significant difference. You don’t need a bystander or a family member or a caregiver to do HypoPen.

Are you still considering other use cases for glucagon other than severe hypoglycemia?

The answer is absolutely yes. Since you and I talked last, we’ve done quite a bit of phase 2 clinical work in hypo unaware syndrome and post-bariatric hypoglycemia, PBH is really interesting because these are people who are not diabetics. They’re just people who have had bariatric surgery and develop this syndrome where certain meals cause a severe hypo.

And we’re also looking at exercise-induced hypoglycemia. We’ve got really good data from our trials on exercise. In one arm of the trial people didn’t change their insulin dose, they just gave themselves a microdose of our liquid stable glucagon right before exercise. They then did about an hour’s worth of strenuous aerobic exercise and they did quite well. We put all that data from different studies in front of the FDA.

We’re still talking with the FDA about how to get a study for phase 3 to get an indication for [glucagon] use during exercise. We haven’t got an answer on that yet. We’re committed to try to get a vial of liquid glucagon to the market for micro-dosing in some manner, because we know that it’s something that people need and people use in these situations.

Is a pramlintide-insulin combo something that is still in the Xeris pipeline?

Absolutely. I think it could be one fantastic drug. The reason I say that is the original promise of pramlintide was that as a co-administration with insulin, it would help insulin work harder and you’d have to use less insulin. But the co-administration has not worked very well because it requires a lot of titration.

And it never fulfilled its promise. When we take pramlintide and analog insulin, and we formulate them in our system and put them together, they go together very nicely. The ion binding is very good.

If you were to design a better mealtime insulin, you would want something where you use less insulin. Where you don’t have that severe drop in glucose or hypoglycemia on injection, and that it stays around longer. So you have post-prandial control and it stays around long enough that it may slow gastric emptying as well, which could lead to some weight loss. And we showed that in our Phase 2 trial. We believe we have that drug.  We’re currently talking to the FDA about a phase 3 program in order to get it to market.

Thanks again for your time today. Any final thoughts you’d like to end on?

Our message for the community is ask your doctor for glucagon. If you’re on insulin, you’re at risk for severe hypoglycemia. Maybe you’ve been on insulin for 20 years and you’ve never had a severe hypo, but that doesn’t mean you won’t have one. Talk to your physician. Be safe. Be prepared.

WRITTEN BY Todd Boudreaux, POSTED 08/04/21, UPDATED 11/17/21

Todd was diagnosed with Type 1 diabetes in 2000, and has been unofficially advocating for T1D ever since. Before joining the team at Beyond Type 1, Todd wrote and produced television shows for Discovery Channel, Travel Channel and Animal Planet.