Adamis poised to challenge Mylan's pricey EpiPen with lower-cost Symjepi injection

EpiPen new
Adamis, with new FDA approval for its epinephrine injection Symjepi, is taking aim at EpiPen’s pricing.

Mylan’s EpiPen will soon have another lower-cost competitor to contend with. Adamis Pharmaceuticals, whose epinephrine injection was turned back by the FDA last year before the EpiPen pricing controversy erupted, won an agency nod Thursday.

Dubbed Symjepi, the Adamis single-dose syringe won’t be an interchangeable generic, but it will compete head-to-head with the Mylan brand, and analysts see it as a drain on the company’s sales—and, potentially, profits.

Adamis is taking aim at EpiPen’s pricing, and that of its competitors, for that matter.

“We want to position this product as a low-cost alternative to the other current offerings in the anaphylaxis market,” an Adamis spokesman told FiercePharma via email.

EpiPen, Mylan’s top-selling product with more than $1 billion in sales, has long dominated the epinephrine injection market, partly through aggressive marketing and lobbying for mandated purchases by schools and other facilities, partly because potential generics have been turned away at the FDA.

Of course, the hefty price increases that took EpiPen’s two-pack cost above $600 landed Mylan in an unwelcome spotlight last fall.

RELATED: EpiPen set to lose $800M in sales by 2018, thanks to new rivals, authorized generic: analyst

Mylan is already facing an EpiPen decline because of its own authorized generic, announced as an attempt to quell the pricing brouhaha, and competitors that have shifted into higher gear since. Medicaid rebates presumably will increase as well, given that Mylan had been underpaying them in previous years, bringing down net sales even more.

Mylan has made much of EpiPen’s autoinjector, citing tweaks to its design as one reason for the repeated price hikes. Adamis’ product is different—a prefilled syringe—but CEO Dennis J. Carlo figures its device has advantages, too. Its “small size and user-friendly design” are two reasons why Adamis believes “Symjepi could be an attractive option for a significant portion of both the retail (patient) and nonretail (professional) sectors of the epinephrine market,” Carlos said in a statement.

David Maris, an analyst at Wells Fargo, has been in touch with Adamis about its pricing and strategy, and he said the new product is likely to dent Mylan’s business.

“With an anticipated lower cost and attractive design, we believe Symjepi will be a meaningful competitor to EpiPen,” Maris wrote in a Thursday note. “As Mylan does not routinely disclose EpiPen sales, the company's potential exposure is not clear, but we expect a significant portion of EpiPen sales (which were >$1 billion in 2016) and gross profit may be at risk.”

RELATED: Mylan faces FTC antitrust probe over generic-thwarting EpiPen tweaks

It’s not a good time for Mylan to face yet another challenge to its numbers. The company is in a proxy fight with some angry institutional investors looking to oust a half-dozen members of its board. Three proxy advisers have backed their case, citing the company’s “egregious” executive compensation, its stiff-arming of a potential offer from Teva Pharmaceutical Industries a couple years ago—and, of course, the EpiPen controversy and its fallout, including federal investigations and lawsuits.

Adamis is weighing different strategies for rolling out the product. The company is “exploring all of its commercialization options, including the possibility of connecting with a licensing partner for U.S. rights,” the spokesman said.

In a release, Adamis said it’s in discussions with potential partners to make sure patients have broad access to Symjepi. It’s building inventory levels now for a launch it expects in the second half of this year.