EpiPen alternative Symjepi gets FDA OK

Dive Brief:

  • U.S. regulators have approved a new allergic reaction medication that could provide consumers with an alternative to Mylan's epinephrine autoinjector, EpiPen.
  • Adamis Pharmaceuticals' Symjepi comes as two pre-filled, 0.3 mg dose syringes of epinephrine, and is indicated for Type 1 allergic reactions, including anaphylaxis due to bug bites, foods or other drugs. The company plans to launch the product in the second half of this year, and is gearing up to file another New Drug Application (NDA) for a "junior" version, CEO Dennis Carlo said in a Thursday statement.
  • "With an anticipated lower cost, small size and user-friendly design, we believe Symjepi could be an attractive option for a significant portion of both the retail (patient) and non-retail (professional) sectors of the epinephrine market," Carlo said.

Dive Insight:

Symjepi may add another treatment option for patients with severe allergies, but it's a bit of a stretch to say the drug will rival Mylan's dominant player.

Not only does EpiPen make up the lion's share of the epinephrine market, but it also benefits from being administered via auto-injection. Patients have shown time and again better reception and greater adherence to medications that are easy to use, so whether or not Adamis' drug is as effective as Mylan's, the real uphill battle will be convincing consumers to adopt syringes — especially in a drug that is typically used on and by children.

Adamis has the chance to gain some ground, however, given EpiPen's recent setbacks, which have included public and Congressional outcries over the drug's pricing and a recent recall that spanned across the U.S., Europe, Australia, Japan and New Zealand.

What's more, some analysts believe Symjepi has the goods to outperform Mylan's drug, as well as Impax Laboratories' Adrenaclick and Kaléo Pharma's Auvi-Q.

"We believe [Symjepi] may actually be a better, more user-friendly product (design wise) versus EpiPen, Adrenaclick and AuviQ," Maxim Group analyst Jason Kolbert wrote in a June 15 note. "The market opportunity is large. Even with just moderate market share assumptions, [Symjepi] becomes a significant product."

As for pricing, Adamis hasn't released the wholesale acquisition cost (WAC) for the product. Mylan's branded and generic versions of EpiPen are currently sold for $608 and $300, respectively. Auvi-Q, meanwhile, is $4,500 out of pocket, but falls down to $360 for families making under $100,000 annually.

The WAC for Adrenaclick is $365, though consumers can get it for about $110 through CVS. Maxim Group warned, however, that Impax's generic is a "inferior product" and likely won't set the pricing tone for Adamis.

In any case, Adamis is reaping the rewards for bringing its first drug to market. The San Diego-based pharma saw its stock leap nearly 50% on the news, closing at $5.75 per share on Thursday.

Symjepi's approval is also surely a relief for Adamis, which has had a rocky road with regulators. The company submitted Symjepi's initial NDA back in May 2014. Along the way, the Food and Drug Administration issued two complete response letters: one in March 2015 and another in June 2016.

The first of those rejections was based on chemistry, manufacturing and controls (CMC) concerns, specifically whether the syringes could deliver the correct volume of medicine. The second rejection called for expansions to two trials, data from which Adamis incorporated in its filing. In January, the FDA accepted the submission.

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Filed Under: Marketing