peanuts
Millions of Americans have peanut allergies. Photograph by Patrick Sison — AP

How one startup plans to end the EpiPen monopoly

Jul 21, 2015

Kleenex has tissues. Band-Aid has bandages. Dunkin has doughnuts. And EpiPen has automatic epinephrine injectors.

To the millions of Americans with food allergies (dairy, peanuts, soy, shellfish, and so on), a shot of epinephrine can be the difference between life and death. A dose of the drug, commonly known as adrenaline, fights the anaphylactic shock that an allergic reaction can trigger. That’s why a portable device, such as an EpiPen, is a constant companion for many allergy sufferers.

Mylan (aapl), the company that sells the ubiquitous EpiPen, controls some 90% of the $1.3 billion U.S. auto-injector market. But, according to startup Windgap Medical, a good alternative is long overdue. Their Abiliject auto-injector, due for release in 2018, promises to be smaller, have a longer shelf life, and be easier to use than anything that’s come before it.

The Somerville, Mass., company just raised $4 million in Series A funding, which, according to co-founder and CEO Christopher Stepanian, gives them enough cash to finish development and begin finding its go-to-market partner. They had previously raised an additional $1.9 million.

The key to Abiliject, Stepanian explains, is its extended shelf life. Over the last four years, Windgap has developed a proprietary method to store epinephrine in a dried or powdered form and reconstitute it seconds before injection. The dry formulation is good for several years, and won’t degrade when exposed to light or extreme temperatures. For comparison: In perfect conditions, an EpiPen will expire in 18 months, and, when exposed to heat over 86 degrees, can degrade even faster.

Windgap also promises increased usability. “One of the big failure modes for EpiPen is that folks get confused in the heat of the moment,” Stepanian explains. “Maybe they got trained years ago on how to use it or have forgotten, and they inject their thumb by mistake. We saw that as being an opportunity to innovate, to make it pretty obvious which end is the sharp one.”

Patients activate the Abiliject by twisting off an end cap, which signals the dry drug within to reconstitute. A nose-fire trigger then delivers the drug directly into the thigh muscle. Bonus: The device is about the size of a Bic lighter—less than half the girth of an EpiPen—so Stepanian believes users will be more likely to carry it with them at all times.

Windgap is already on its second functional Abiliject prototype, and has been working closely with allergists and patients to refine its design. Pricing is still up in the air, as commercialization is years off and Windgap hasn’t yet inked any to-market partnerships.

Of course, this isn’t the first time a competitor has tried to chip away at the EpiPen’s monstrous market share. Most recently, French pharmaceutical company Sanofi began distributing the Auvi-Q, a talking injector about the size of a deck of cards. Other alternatives, such as Twinject, have come and gone. And pharma company Teva has generic offerings, as well. (Interesting note: Teva (tevjf) is currently attempting a Mylan takeover, which could put both generic and name-brand injectors under the same umbrella.)

Yet despite such bumpy history and an uncertain future, Stepanian thinks the market is ripe for disruption. “We saw the market uptake of the Auvi-Q, about 7% over the first year, as being a hopeful sign that there is interest out there ...,” he says. “[They’re] displacing a trusted branded product with another branded product—that's exceptional.”

What’s more, Stepanian says, Windgap’s technology has applications outside epinephrine injectors. For example, the company’s core technology, which allows a drug to be reconstituted quickly and easily, could be especially helpful in a class of drug called biologics, which are derived from or emulate living organisms. The drugs, including treatments for rheumatoid arthritis and Crohn’s disease, are costly and short-lasting. “The proteins, the enzymes, the what have you, they start breaking down pretty quickly when they're in solution,” Stepanian explains. “Keeping the drug dry or freeze-dried in a powder form until it’s needed makes a lot of sense.”

For now, though, Windgap is focused on bench-testing Abiliject and making sure they deliver a product that helps allergy sufferers better than what’s currently available. “I have great sympathy and hope that our product will really help people sleep a little better at night, knowing that it's more likely that they'll have an epinephrine auto-injector with them,” Stepanian says.

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