The EpiPen, the anti-allergy device that has been under investigation because of huge price increases, is soon going to have some competition.
Kaleo Pharmaceuticals, a small privately held drugmaker, says it plans to bring the Auvi-Q epinephrine auto-injector back onto the market in 2017.
Both the Auvi-Q and EpiPen devices inject a dose of epinephrine into the thigh of a person experiencing a severe allergic reaction.
Auvi-Q, one of the only direct competitors to the EpiPen, was pulled from the market by the pharmaceutical giant Sanofi last year. Sanofi said it had received a handful of reports that the device didn't deliver a reliable dose of epinephrine.
Kaleo, which invented the Auvi-Q device, bought the rights to it back from Sanofi in February, said Spencer Williamson, the company's CEO, in an interview with Shots.
The Auvi-Q is smaller than the EpiPen — about the size of a credit card and as thick as a smartphone — and it has audio instructions that guide a user through the injection process. Kaleo also makes Evzio, a popular auto-injector for naloxone, the opioid antidote used to treat overdoses.
Eric Edwards, who was an inventor of the Auvi-Q and founder of Kaleo, says the company has fully automated the production of the devices and has a 100-point quality control inspection to ensure they deliver consistent doses of epinephrine to those who use them.
The reintroduction of Auvi-Q to the market will bring new competition to the EpiPen, which has been the subject of headlines, consumer anger and congressional investigations because its manufacturer, Mylan, raised its price about $500 over a few years. A two-pack of the devices, which have been on the market for decades, were listed at $633 at Walgreens Pharmacy, according to GoodRX.
Mylan in August said it will introduce a generic version of EpiPen to the market at half the price.
Williamson declined to say how much Kaleo expects to charge for Auvi-Q. He said the company will work to ensure that out-of-pocket costs to consumers will be low.
That suggests the company could try to use strategies similar to those used by Mylan, where they keep the list price high to maximize the amount insurers pay, while helping consumers with the costs of their copays and deductibles.