An EpiPen Rival Is About to Return to the Shelves

An EpiPen Rival Is About to Return to the Shelves

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Each AUVI-Q has an identifier and is tracked throughout the manufacturing process.

The EpiPen is about to get some more competition.

The makers of the Auvi-Q, an EpiPen alternative taken off the market last year, announced on Wednesday that they would bring it back in 2017. The move is certain to be welcomed by many patients and lawmakers, who have denounced the rising price of EpiPens and the lack of strong competition.

But whether the Auvi-Q’s return will do much to lower prices is far from clear, especially since it cost more than the EpiPen when it was on the market. And a generic version of the EpiPen, recently announced by the EpiPen’s manufacturer, Mylan, is expected to be available before the end of the year, which may further lower the price of similar products.

In an interview on Tuesday, Spencer Williamson, chief executive of Kaléo, which owns the rights to the Auvi-Q, said the company was working hard to ensure the product would be affordable. But he said the list price had not yet been determined. The Auvi-Q, like the EpiPen, is designed to inject an emergency dose of epinephrine in the event of a severe allergic reaction.

“We understand that price is central to this conversation,” Mr. Williamson said. “We believe that patients should be able to obtain the product without insurance barriers or high out-of-pocket costs. That’s our focus.”

Members of Congress, who have been scrutinizing Mylan’s pricing and marketing practices, cautiously welcomed the development.

“Increased competition is certainly good news,” Representative Elijah E. Cummings of Maryland, the ranking Democrat on the House Committee on Oversight and Government Reform, said on Tuesday. “But we need much greater transparency over the massive profits these companies are making in order to ensure that the American people have affordable access to these lifesaving drugs.”

When the Auvi-Q came on the market in 2013, it was hailed as a clever alternative to the EpiPen, with a slim, rectangular, pocket-friendly design and voice instructions that guided users through the injection process. It had an interesting back story, too, having been invented by twin brothers who grew up with food allergies but yearned for an easier-to-use alternative to the EpiPen.

The brothers, who founded Kaléo, licensed the Auvi-Q to Sanofi, a major pharmaceutical maker with the marketing muscle necessary to compete with a giant company like Mylan.

Within a couple of years, the Auvi-Q had about 10 percent of the market and a loyal following. But in 2015, Sanofi withdrew the product from the market after reports that it was not delivering proper doses of epinephrine.

Last February, Kaléo executives reclaimed the rights to the product and began working on safely getting it back on the market, taking steps such as adding a fully automated production line with multiple quality checks.

Kaléo’s intelligent high-tech, 100% automated robotic production line built with the highest standards in safety, precision and consistent quality.

As Kaléo was in the middle of that push, a fortuitous turn of events for the company took place: The public’s attention — and anger — turned to the pricing of EpiPens.

But the arrival of the Auvi-Q in 2013 did not drive down the price of the EpiPen. It may have even done the opposite. Last month, Mylan cited the debut of the Auvi-Q — and a list price that was often 10 percent higher than the EpiPen’s — as one factor in raising its own prices, according to a letter the company wrote to Senator Charles E. Grassley, Republican of Iowa, in response to his questions about the EpiPen’s pricing.

When the Auvi-Q was withdrawn from the market in late 2015, its list price was about $500 for a pack of two, according to the Elsevier Clinical Solutions Gold Standard Drug Database. The list price for a pair of EpiPens now tops $600, compared with about $100 when Mylan acquired the product in 2007.

The list price of drugs does not always line up with their true cost, however, because it does not reflect rebates that drug manufacturers give to insurers and employers in return for being favorably covered by their plans. The rebate amounts are not typically made public.

Sanofi and Mylan appeared to have competed fiercely when it came to how they would be covered by Express Scripts, a large pharmacy benefits manager that negotiates on behalf of insurers and employers. A spokesman for Express Scripts said on Tuesday that the two companies agreed to significant discounts in 2015.

Mr. Williamson said Kaléo was still negotiating with managers like Express Scripts to determine how the Auvi-Q would be covered.

Kaléo has also come under scrutiny over pricing. In June, two senators asked the company to explain what it was doing to ensure access to Evzio, a similar injection device that dispenses the anti-overdose medication naloxone. Kaléo charges $3,750 for a pair of Evzio injectors. The company says it has a generous patient assistance and donation program that ensures people who need the product can get it.

Dr. Eric Edwards, one of the twins who invented Auvi-Q, said the product’s ultimate selling point was its convenient design, which he said made it more likely to be carried by people who needed it. (Detractors, including Mylan, have said the EpiPen’s distinctive cylindrical shape makes it easily located in an emergency.)

“We think that what’s been missing from a lot of these conversations is innovation,” Dr. Edwards said.

That distinction could persuade some of the Auvi-Q’s most ardent fans to pay as much, if not a little more, for the product. Laura Jackson, a Lexington, Ky., advocate for people with food allergies, said her son adored the Auvi-Q because it was easy to carry in the pocket of his jeans or shirt.

When it was withdrawn, “I practically had to wrestle the thing out of my son’s hands,” she said. “This is great news.”

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