Boston-area startup Windgap Medical is going right up against the ubiquitous EpiPen: It’s working on a more streamlined version of the epinephrine auto-injector.

As allergies rise, so does the need for on-the-spot epinephrine treatment. Windgap wants to win a chunk of this fast-growing, $1.3 billion market.

But it’s a tough market. For nearly three decades, the EpiPen has been the go-to device for the all-out allergy attack: It has long commanded more than 90 percent of the global auto-injector market. Still, the EpiPen has some core flaws in terms of being user-friendly – and no one likes a monopoly.

There are other contenders — Sanofi’s two-year-old Auvi-Q is the frontrunner — but the market’s ripe for new options for patients with allergies, CEO Chris Stepanian said.

Windgap is targeting a market release by 2018, so it’s still a few years away. It just raised the first $4 million tranche of its Series A from a syndicate of angel investors. Prior to that, it had raised $1.9 million in seed funding to support its operations. The startup was a 2012 Mass Challenge winner.

Windgap’s technology

Stepanian made a case for the Windgap device, saying it holds these three improvements over the EpiPen:

• The Windgap device is smaller – about the size of a Bic lighter. By contrast, the EpiPen is bulky for someone with allergies to carry around and it’s difficult to fit in a pocket. After all, one criticism is that patients —or when it comes to children, their parents — don’t always carry auto-injectors around. Then they don’t have them when they have an allergy attack. Windgap’s approach is to make it easier to keep on hand at all times.
• Windgap has engineered a dry formulation of epinephrine that’s more shelf-stable and less sensitive to temperature. Again, it’s more pocket-friendly because it can withstand the heat of a pocket without worry of denaturing. This one’s notable, because it’s meant to outlast both the EpiPen and the Auvi-Q.
• Windgap’s more intuitive to use: Even when you’re having an allergy attack, you can immediately know which end’s the pointy end. It’s common for EpiPen users to hold the device backwards and inject epinephrine into the wrong body part. Furthermore, Windgap’s design’s meant to reflect today’s aesthetics – it’s meant to be sleek and understated.

Windgap’s device will follow a similar pathway to generic drug-device combos. In terms of intellectual property, the WindGap device has more than a dozen provisional patents and patents pending surrounding device design and the drug formulation, Stepanian said.

But in terms of pricing – that’s something that will be left up to the commercialization partners, Stepanian said. He didn’t address potential reimbursement.

The EpiPen, without insurance or subsidy, runs up to $400 for a pack of two. There are many coupons and subsidies for the auto-injectors. They tend to be shelf-stable for about two years, though patients tend to hang onto them far longer than they should.

Breaking the monopoly

The EpiPen has dominated the market for decades, despite a litany of complaints against its usability. Because it does work, has solid brand recognition, and a maker – Mylan – that defends its market share ferociously.

“There are a number of organizations trying to work on various solutions for epinephrine auto-injectors, but the market seems to be dragging,” Stepanian said.

After all, this isn’t the first time a device has been pitted against the EpiPen: Big pharma absolutely recognizes the market potential of a better auto-injector. The Auvi-Q hit the market in 2013 in a $230 million Sanofi licensing deal.

The Auvi-Q addressed some of the issues WindGap’s also after: It’s essentially a talking EpiPen that’s the size of a credit card.

The New York Times wrote at the time:

Still, the Auvi-Q faces long odds: several other companies have tried and failed to challenge the dominance of the EpiPen. Last year, the manufacturer of the only competing products on the market, the Adrenaclick and Twinject, announced it would stop making them.

In its first year on the market, the Auvi-Q took over about 7 percent of the epinephrine auto-injector market share, Stepanian said. That uptake of the Auvi-Q is heartening to Stepanian, showing that there’s “stickiness on the market,” he said.

Mylan has been extremely vigilant in maintaining its share in this $1.3 billion auto-injector market. But times are changing:  There are a number of generic alternatives to the EpiPen readying for the market. By the time WindGap’s market-ready, the landscape may have evened out more.

“Every device so far that has come to market has had some flaws, and Mylan has done a good job of defending its position,” Stepanian said. “We’ll be dealing with all of this at some point in the future,  but I think we’ll be in a good position with our product.”

Photo: Courtesy of EpiPen