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he price of EpiPens, used to treat severe allergic reactions, has soared, more than quintupling since 2004. One reason: There’s just not much competition.

Several rivals to the EpiPen, which is manufactured by Mylan, have emerged in recent years, only to fall by the wayside. Sanofi’s Auvi-Q was recalled late last year. The FDA is asking Adamis, a small San Diego biotech developing its own pre-filled auto-injector, for more patient data. Another auto-injector, the Adrenaclick, isn’t considered on par with the EpiPen, and is prescribed far less frequently.

STAT spoke with Chris Stepanian, CEO of Windgap Medical, a Boston startup that’s in the process of creating a smaller, lither epinephrine auto-injector, called the Abiliject, that could be ready for FDA review by 2018.

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STAT wrote this week about how EpiPens are so expensive these days. What’s the deal?

Prices for epinephrine auto-injectors have continued to go up — partially because of a lack of competition. That’s likely not going to go away anytime soon.

Mylan’s doing what a lot of businesses do when there’s not a lot of competition: They raise prices. They’re doing what’s right for their shareholders, and that’s it.

But here’s one thing to keep in mind: Most insurers only cover one pair of EpiPens each year, which retail around $600. But parents with kids who have serious food allergies usually have to keep a pair at school, a pair at squirreled away at home, and a pair that each parent carries around. That adds up pretty quick — and families are often paying out of pocket, full retail.

So how’s your device different from the EpiPen?

We’re about 40 percent smaller than the EpiPen, so it’s lighter and easier to carry. It’s designed to fit in a pocket. We’re working on proving our epinephrine formulation’s temperature stability — so even if you leave it in your car on a hot and sunny day, you don’t have to throw away the device. We’re aiming for a longer shelf life than the EpiPen — and we’re hoping to make ours more intuitive to use.

How often do people use their epinephrine auto-injectors?

EpiPens aren’t actually used all that often. The number of EpiPens that are actually used to try and save a life is much, much lower than the ones kept on hand — just in case. Most are thrown away, unused.

Why do people throw away their EpiPens?

Let’s say a family’s at a mall, or a beach, and they leave the EpiPen in the car, baking all day. What’s a parent going to do? They definitely consider throwing out the device — because it can be exposed to temperatures well in excess of what the FDA considers acceptable. And, of course, there’s an expiration date on these things.

Does Sanofi’s recall of the Auvi-Q impact Windgap?

Our board asked us the same question … [but] I’m not worried. … You’ve got to be careful when you submit to the FDA regarding emergency devices that will save folks’ lives. If that doesn’t work, it’s a problem.

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  • Given the way that those devices are made, wouldn’t it be possible to refurbish them with a new syringe, instead of throwing away the whole contraption?

  • Windgap has only raised $3,000,000 in private placement financing for the device according to public documents would need at least that much to start the required stability studies. Their best bet is to license the product to a experienced large device company. The acquiring company will bring its army of chemists and patent lawyers and will only give a thumbs up if they believe they have 100% squeaky clean intellectual property with its delivery system and can back its claims of extended stability with hard data.

    http://www.massdevice.com/windgap-medical-raises-3m-epinephrine-auto-injector/

  • EpiPens are practical and easy to use, but before EpiPens there were vials of epinephrine and syringes. Parents and children can be taught to give injections accurately and safely, as have diabetics and their parents learned to inject insulin for generations. I would love to see “the old fashioned way” put Mylan out of business because of its outrageous greed that the company’s CEO indicated was intended to bilk insurance companies for all it could get.

    • Ellen, you are correct. When I lived in the south I developed an allergy to fire ant toxin and thus always carried a syringe of epinephrine with me. I would endorse your recommendations except that today’s parents get 100 PERCENT ABSOLUTELY FREAKED OUT at the the idea of their kid handling an exposed needle. With these auto injectors they never see the needle as if it didn’t exist. Golly gee whiz on my street the parents won’t even let little Johnny walk to the end of the block to catch the school bus.

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