Curses, EpiPen! Another would-be rival falls flat at FDA, leaving Mylan's med unchallenged

EpiPen

Will anyone ever give Mylan’s ($MYL) blockbuster epinephrine injection, EpiPen, a run for its money?

That’s the question now that another potential competitor is out of the running. The FDA stiff-armed Adamis' ($ADMP) prefilled epinephrine syringe, asking for more data. Regulators want the San Diego-based company to expand a patient usability study and product stress testing studies included in the original application.

The way Evercore ISI analyst Umer Raffat sees it, Adamis’ product wouldn’t have been “a large competitor” for EpiPen, given the difference between its prefilled syringe and Mylan’s more convenient injection pen device. But “Adamis could have added to managed care pressures,” through its stated strategy of acting as a discounted product.

Instead, Mylan is home free--a status it must be getting used to, given the failures that have repeatedly befallen its competitors. Back in November, Sanofi's ($SNY) Auvi-Q hit a wall, when an injector fault triggered a hefty recall. Ultimately, the pharma giant yanked Auvi-Q from the market, and then bailed on its marketing partnership with developer PDL BioPharma ($PDLI), putting the med’s future up in the air. It was EpiPen's first real challenger in years.

More recently, the FDA handed generics giant Teva ($TEVA) a rejection for its generic version of EpiPen, flagging “certain major deficiencies” in its letter to the Israeli pharma. With serious issues to work through, Teva said earlier this year that it expects its product to be "significantly delayed"--meaning it doesn’t expect a rollout before 2017.

But while EpiPen may be the only horse in the race, Mylan isn’t slacking on its marketing activities. On the contrary, it’s already rolled out a pair of initiatives this year. With the “Face Your Risk” campaign, the company put an ultra-realistic anaphylaxis episode on TV to raise awareness of severe allergies. Shortly thereafter, it tapped actress Sarah Jessica Parker to help it launch a consumer-generated media initiative inviting children and their families to create and submit short films about living with severe allergies.

- read Adamis' release

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