With EpiPen competitors bearing down, can Mylan maintain its lead?

The emergency epinephrine market is about to be flush with options. At least three new epinephrine marketers are challenging Mylan’s EpiPen, the longtime market leader still reeling after a price-hike debacle in 2016 and now dealing with an ongoing manufacturing shortage.

Earlier this month, Kaléo—maker of chief EpiPen rival Auvi-Q—boosted its marketing and sales strategy with a Walgreen’s deal. The pharmacy will now substitute the Auvi-Q injector automatically if it's out of EpiPens and the patient’s doctor agrees. The Auvi-Q device once had manufacturing challenges of its own when the brand was being manufactured by Sanofi. In 2015, Sanofi issued a recall of all Auvi-Q injectors after it found there was a potential for inaccurate dosage delivery. Sanofi's agreement with Kaléo ended the next year and Kaléo regained full control Auvi-Q including R&D and manufacturing. It has steadily built share over the past two years, mainly distributing the product direct to patients through their doctors.

Two other competitors—Teva’s recently approved generic EpiPen and Adamis’ Symjepi syringe, backed by a newly inked marketing deal with Novartis' Sandoz—are prepping to launch their solutions as well. No dates are set for either rollout, but industry watchers expect both sooner rather than later.

And while the newcomers may have missed the prime September back-to-school window for stocking up, the companies are confident there are still epinephrine market opportunities to be had.

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Mark Flather, Adamis’ senior director of investor relations, said Symjepi’s advantage will be that it's an affordable option—pricing hasn’t been announced yet, but it is expected to cost less than the EpiPen generic list price of $320—and it boasts a unique size and delivery system, too. Symjepi comes as a two-pack of 4-inch prefilled syringes that patients or caregivers administer like a typical shot. Competing autoinjectors are mostly bulkier—only Auvi-Q has a small-sized form factor—and all have a hidden needle that can make it difficult to tell if a dose has been administered. Symjepi was initially rejected by the FDA, but retooling got Adamis the nod in 2017.

"The second CRL that we got, as upset as we were about it, I think the FDA suggestions actually forced us to go back to the drawing board and rethink it. The changes we made after that second rejection resulted in a device that is about as good as we can make it," Flather said. "If it saves even one life, to go through that headache and heartache, then it was worth it."

Kaléo, meanwhile, along with its Walgreens deal, has been pushing its direct delivery service to physicians. The program allows a patient to sign up through their doctor's office for direct delivery to their homes. Patients with commercial insurance can receive up to two injector packs per year for $0 out of pocket cost through its patient assistance program, a Kaléo company spokesperson said via email interview. Uninsured patients with an income of less than $100,000 also receive the injectors free, even though the list price for Auvi-Q is $4,500.

RELATED: FDA fights EpiPen shortage by extending expiration date for some devices

Another competitor already on the market and at pharmacies is Amneal Pharmaceutical’s Adrenaclick. But it's had manufacturing issues similar to Mylan's; Pfizer manufactures both the Mylan and Amneal pens. Yet thanks in part to Mylan’s earlier pricing scandal, Adrenaclick has managed to pick up market share over the past two years, growing its slice of the pie from 2% to as much as 20%, by some estimates.

At the same time competition is preparing to flood the market, Mylan has dialed back its EpiPen marketing. The company has not advertised either EpiPen or anaphylaxis awareness on TV since August 2016, according to data from real-time TV ad tracker iSpot.tv. A recent Kantar Media allergy keyword study also found that EpiPen paid search has dropped to nothing. It went from a 10.8% clickshare in the first six months of 2016, to not significant enough to be measured in 2017, and then to no activity at all the same time period in 2018.

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