Anyone who’s ever looked over a traditional glucagon kit (scary! confusing!) will appreciate this: another company hot on the trail of developing a new compact, one-step injection device for treating severe hypoglycemia. This one is called GlucaGo, from a group of young entrepreneurs out of Purdue University.
Co-Founder Rush Bartlett explains: “Our device holds the drug in a freeze dried form until right before use when the user removes the cap, 
causing the freeze dried drug and liquid to mix. Then just press the device against the skin and you can administer the appropriate injection. Think Astronaut Ice Cream when I talk about Freeze Dried or Lyophilized drugs (why we re-named our company LyoGo). Astronauts don’t have refrigerators on the space shuttle because they weigh too much and take too much power, so they freeze dry their food to keep it from spoiling. Our device does the same thing meaning no refrigeration required for most drugs, especially drugs dealt with by diabetics like glucagon and insulin.”
Many of you may recall my recent coverage of Enject and the GlucaPen they are developing. Both companies are gunning to create the equivalent of an EpiPen for diabetics. If you’re wondering why in the world this hasn’t been done yet, the answer is that glucagon is a fussy substance; it does not remain stable in liquid format and therefore has to be mixed immediately before use. Thus any pen or quick all-in-one delivery device has to have two separate chambers — for the freeze-dried and liquid components — and a mechanism for mixing the two in a flash when the drug is needed.
To do this, Enject has licensed a specialized dual-chamber vial from a company called Vetter in Germany. The GlucaGo team, on the other hand, claims it has developed a brand new proprietary type of mixing technology, using low-cost mainstream components.
Enject is using a synthetic form of glucagon from a company called Bachem out of Switzerland. GlucaGo may use the same, or possibly a new generic drug compound, which would allow for a cheaper, “non-branded” version of the instant pen. Synthetic glucagon is not yet approved by the FDA (on the market only in Japan), but all parties seem confident that it will be soon.
The differences lie in how the delivery devices work. “There are two chambers in our device, but it’s not spring-loaded,” Rush explains. “Imagine a chapstick container, but when you pull the cap off, there’s a mechanism that causes the barrier to move away and mix the two components.” Glucagon is just the beginning for this technology, he says. His company envisions uses for up to 200 different freeze-dried formats of drugs, including Atropine, morphine, anti-viral drugs, cancer drugs, and pentothal syringes given in the case of emergency C-sections.
Watch this intro video explaining the Lyo-Go approach:
In the case of pentothal, for example, there is huge potential for cost savings, Rush says. The drug can’t remain stable in liquid format, and mixing it by hand is a tricky and time-consuming task. But since hospitals need it ready daily for emergency birth situations, “they’re now preparing it in advance every day because they don’t want to mix in an emergency. Then after 7 days it’s all thrown out, so there’s lots of waste.” The LyoGo product would do away with the need for pre-mixing.
Meanwhile, back in the diabetes world, Rush’s company will be battling for ground versus Enject and a few other players in the emerging glucagon pen market. Here’s a quick overview of the landscape:
The Players
Besides GlucaGo and the Enject GlucaPen, two other companies are working on similar products: Marcadia, out of Indiana, recently announced a deal with Eli Lilly to develop a liquid form of glucagon that could remain stable for six months, delivered via “standard autoinjector”; and Biodel, based in Connecticut, is doing something very similar.
Cost Factor
The real reason a convenient glucagon device is not yet on the market is probably “sheer cost and the size of the market,” Rush admits. “A few hundred million is not huge potential for a big Pharma company.” In addition, specialized components like the Vetter chamber used in Enject’s product can drive up production costs to unacceptable levels, he claims. When contacted, a spokesperson from Enject says this is a “misrepresentation,” and that their product demands an “only slightly more expensive cost of goods” than the kits on the market now.
Did you know, btw, that current glucagon kits from Eli Lilly cost less than $5 to make, but they are selling them for $100? These alternative vendors hope that by driving the price tag down to around $20, patients can afford to keep more than one kit around, in different locations where they might be needed — IF insurers are willing to cover multiple units per patient per year, that is (big if).
Shelf Life
Another challenge is how long any of these products can remain effective. The folks at Enject tell me that in order to commercially market any drug, you need a minimum of 16-18 months of shelf life from the date of manufacturing. The EpiPen just makes it at 16 months’ efficacy. Both Enject and GlucaGo are claiming two full years of shelf life, but this hasn’t been proven yet. “The holy grail is is to get it stable for long enough, and also resistant to agitation, and to a wider range of temperatures,” Rush says.
Meanwhile, Enject is ahead of the game in development. They are prepping to begin their “animal study” (toxicology) soon. GlucaGo won’t be doing theirs for another year and a half at least, they tell me. But that’s when things will get interesting.
“The rubber’s gonna hit the road when the data comes out on the safety and efficacy of these various devices,” Rush says.
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This is really exciting news. It sounds like there are still plenty of hurdles, but, none impossible to get over. Nice
This is a great post. As a type 3, caring for and ensuring the safety of my number 1, type 1 kiddo Joe, I have found the current Glucagon kits to be prohibitive in instructing lay personnel how to use them. The needle, the reconstituting, the drawing up of the now constituted medication can be very confusing AND then you add in a life-threatening hypoglycemic event…well forget about it.
I have been hoping to see something, anything, along these lines to hit the market. I have heard of the other products you mentioned years ago. This one is new and holds promise as well…God Speed!
This was extremely exciting to read! Amazing technology that will make all the difference in the world. I’m rooting for you guys!
Thanks for your support! If you want to reach out to us directly dont hesitate to contact me at Rush.Bartlett@LyoGo.com.
You article, a review of their website, and the pitiful prototype make it clear that LyoGo don’t know much about lyophilization or sterile injectable drug manufacturing.
This is a fun grad school project, but the engineering challenges are immense. I’d take these guys seriously once they have convinced at least one supplier to take on the project.
Thank you for sharing this news. This looks nice, good luck.
This is really positive news! Let’s hope better technology is on the market soon.
As the parent of a school-aged child, I too am looking for improvements in the delivery of glucagon that makes it easy for teachers and staff to give it when required without fear or confusion.
For what it’s worth, I have begun using expired kits to actually show school staff how to mix it and inject it (into fruit) and the process is actually simpler than it seems. I was amazed when I actually used one for the first time how quickly the tablet dissolves in the liquid.
For me the issue is dosage. The steps are easy to follow, but I have to label our kits with “mix all, inject half.” I am looking forward to glucagon, whether in it’s current form or in a new one step form, that has the correct dosage for children.
Our insurance covers multiple kits a year and we carry one at all times in her pump supply bag and have three stashed at school: in her classroom, in the music room where she would likely be during a lockdown, and in the office with the rest of her supplies.
It’s a shame that there is a short shelf-life and that kits expire before use. But I continue to look at the purchase of glucagon kits like home or auto insurance: You don’t want to ever have to use it, but you’re glad you have it when you actually need it.
And for naysayers that claim there isn’t a large enough market, if there was a cost-effective and easy to use product I would bet that many people who don’t carry glucagon currently and SHOULD would purchase it more often. If manufacturers of glucagon want a larger market, then all they have to do is work with insurance companies to have them covered at a copay that is affordable to more patients.
OK, I must be missing something. Why would a pwd pay $100 for something that does the same thing as a sugar cube or some crackers? Are pwd supposed to be that stupid?
@Jim – excuse my candor, but you are missing the point. These pen solutions are for patients who are UNCONSCIOUS, and therefore not capable of ingesting sugar cubes or crackers without choking to death. Also, the $100 fee is that to INSURERS, not what we end-user patients pay out-of-pocket, of course.
Oh, and Happy Holidays to you!
Leighann has it absolutely right. Delivery is everything. You can buy an ampoule of Epinephrine and a syringe to go with it for $3, but an EpiPen also costs $100.
Glucagon kits are user-unfriendly and risky, so it shouldn’t be surprise that it is a modest size market. An easy-to-use pen will make a huge difference.
Amy’s previous story on Enject’s GlucaPen, has an embedded table that makes it clear that Severe Hypo is a much bigger issue than Severe Allergy, but EpiPen sales are 3X Glucagon Kits. The difference? Delivery.
P.S. Leighann, according to their website, GlucaPen will have a Jr version with the correct dose for kids.
I probably wouldn’t buy it if I can’t dose it myself. I.e., I hope it’s not a “one-dose-fits-all” solution. What about people who want to use mini-doses etc.
The real problem that needs to be solved is to figure out how to make glucagon more stable in solution.
[...] Tenderich of Diabetes Mine: GlucaGo for Instant Hypo Treatment (Always glad to see potential improvements in the delivery system of glucagon for severe [...]
Also of note is the fact that on January 3, 2011, Roche announced it was acquiring a company known as Marcadia Biotech, which is an Indianapolis-area startup by some former Lilly scientists which is working on a glucagon analogue that would be pump-compatible (meaning, it would work in a bi-hormonal pump). They still have a bit more development ahead of them, but anything that brings some competition to this staid, uncompetitive market would be welcome news.
Also Intelliject still is on the radar for a glucagon autoinjector as well.. Guessing they are going to probably offer it to Sanhofi to market it, similar to the Auvi-Q epi injector…