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.
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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:
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.
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).
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.