We spend a lot of time around here talking about diabetes and keeping our blood glucose levels from getting too high. But we haven’t spent any time, really, talking about the treatment for seriously low blood glucose levels. I’m talking about glucagon.
Today, glucagon as an emergency medication carries the same set of instructions that it has for a long time: A nine step set of procedures (according to Eli Lilly & Co.) that involves using a syringe to inject an inactive ingredient into glucagon, mixing it, and drawing it back into the syringe and injecting it into the hypoglycemic patient.
I guess that sounds a little antiquated, plus a little time-consuming at a time when every second counts. But what can be done about that? Is there anyone out there working on streamlining glucagon delivery?
I met a couple of people back in March who are with a company that is working hard on new ways to make glucagon simpler and easier for anyone who may need it to treat hypoglycemia. Austin, Texas based Xeris Pharmaceuticals is on the front lines in a niche part of the market, working on a couple of projects and getting funding from the National Institutes of Health.
One of those projects is something called the Glucagon Pen (or G-Pen™). Also, they’ve received additional funding recently via a Phase II installment of a Small Business Innovation Research (SBIR) Fast Track grant to advance the company’s room-temperature stable, non-aqueous glucagon formulation for the advancement of a bi-hormonal pump artificial pancreas. You heard that right. Bi-hormonal. Insulin and Glucagon. The total of the grant funding amounts to $1.05 million.
Today I’ll be sharing a brief interview with a company representative, and information on some of their competitors.
I had a chance to ask a few questions of Saretta Ramdial, Manager of Corporate Affairs at Xeris. I had a few more questions besides these, but they are on hold for now. Some things can’t be revealed while research continues.
Stephen: I met part of your company’s team back in March at the Capitol-area JDRF conference. Are you going to a lot of these? Are they all patient-related functions, or are there conferences, etc. featuring healthcare professionals that you’re also going to?
Saretta Ramdial: We attend a number of different types of conferences that range from scientific and technology-focused to patient-advocacy focused events. This year, we’ve participated in the JDRF Type 1 Now conference in Austin, TX (our second year in attendance) and the JDRF Research Summit in Bethesda, MD (where we met you!). We plan to attend the ADA’s Scientific Sessions Conference as well (we had both of our abstracts accepted this year). We also attended the Taking Control of Your Diabetes conference in December 2012 which was held in Austin, TX.
Stephen: Tell me about how Xeris is revolutionizing the idea of glucagon delivery. I understand this includes glucagon that doesn’t require mixing, and can be delivered via a pen?
Saretta Ramdial: Our lead product in development is the Glucagon Pen or G-Pen™ which utilizes our proprietary, room-temperature stable, liquid formulation of glucagon, a rescue drug for hypoglycemia. The current standard of care is a nine-step process which can seem arduous in an emergency rescue situation where the caregiver must assemble and administer an intramuscular injection. From the patient perspective, Xeris’ solution would be more straightforward than and just as effective as the current glucagon kit because of its patient-friendly approach and ease-of-use. The G-Pen™, similar to an EpiPen™, would be a pre-loaded ready-to-use auto-injector device that would cut the administration of glucagon down from nine steps to two (uncapping and pressing the pen against the skin).
The G-Pen™ technology will be applied to a mini-dose glucagon pen (G-Pen Mini™) which can be used for smaller zero-calorie dosing applications for mild to moderate hypoglycemia. This is especially important for people with weight management concerns when it comes to managing the sometimes unpredictable rollercoaster of blood sugar levels.
Stephen: Are you receiving any funding from sources like JDRF, ADA, or other diabetes organizations?
Saretta Ramdial: We receive funding from a number of sources including the National Institutes of Health (NIH), The Helmsley Charitable Trust, and The Emerging Technology Fund through the State of Texas Governor’s Office.
Stephen: Do you have any competition in this space right now? (I’ll be looking this up anyway, but I thought I would ask).
I actually didn’t get an answer to the question, but I was provided with the link to a Closer Look memorandum, from Kelly Close’s Close Concerns. It’s available via the Xeris website:
The memo is a detailed five page research sheet that goes into great detail about who is working on glucagon solutions (no pun intented). According to the memo (dated June 8, 2012– used with permission), the Xeris glucagon pen is being designed to be stored at room temperature, with a two year shelf life. So… a G-Pen™ with simple steps, that doesn’t need to be refrigerated. And, the work with organizations that are going to clinical trials very soon with an insulin/glucagon bi-hormonal pump for the Artificial Pancreas.
I looked online for information about the competitors working in this space that were mentioned in the memo. I couldn’t find much online, so the following is partly from the memo and partly from what I found online.
– Arecor: The biggest development I’ve been able to find lately is their collaboration with Eli Lilly to develop the same type of glucagon formulation that Xeris is working on.
– Biodel: Again, working on a stable glucagon that will be viable for two years at room temperature. Last September, Biodel was awarded a National Institutes of Health (NIH) grant to develop glucagon for a bi-hormonal AP pump. Last December, the FDA granted orphan drug designation to Biodel’s product. The FDA grants orphan drug designation to help promote development of therapies to treat rare diseases (don’t know how rare diabetes is these days). They may also be eligible for FDA grant funding, certain tax credits, and a seven year grant of exclusivity to their drug should it gain FDA approval. Just last Thursday, Biodel announced plans to apply to the FDA for an Investigational New Drug Application sometime in the next twelve months. If that’s OK’d, they’ll go into clinical trials by the second half of next year, with an eye toward applying for an official New Drug Application with FDA sometime in 2015. In addition to the glucagon, this application should include the injection device too.
– Enject: Speaking of injection devices, Enject has a nice demonstration of their pen on their website. And, that’s about all I could find. The Closer Look memo talked about a delivery system that would reduce the steps needed to inject glucagon down to just three, and mentioned that they anticipate filing a New Drug Application with the FDA by the end of this year.
– Latitude: In April of 2012, Latitude announced that they had developed the first stable glucagon formulation that was ready to inject. They call it Nano-G. Back then, they were actively seeking well-heeled partners to help them bring their idea to testing, FDA approval, and then to the market.
There was one other firm noted in the memo: PhySci. Formerly known as Marcadia, PhySci was acquired by Roche. Since then, not much to report, and I couldn’t find anything on the web about PhySci or Roche glucagon improvements.
In looking into all this, I found out some things, but not nearly enough. I’ve seen a lot, but I haven’t yet seen the actual thing that everyone is shooting for. Truth: Maureen finds the current delivery of glucagon too scary to ever attempt using it. The idea that glucagon can be stabilized and put into a simple pen so any caregiver can administer is an idea who’s time has more than come.
I’ll be watching, and hoping, that glucagon delivery can become as commonplace as just about any other type of injection. I’m rooting for Xeris, and any other outfit who can make this a reality.