Adamis receives FDA approval for epinephrine auto-injector; shares rise

Shares in Adamis Pharmaceuticals climbed as much as 53 percent on Thursday after the drugmaker received FDA approval of its epinephrine auto-injector Symjepi for the treatment of type I allergic reactions. Adamis did not disclose a price for the therapy but CEO Dennis Carlo remarked "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…and non-retail…sectors of the epinephrine market." 

Approval of the therapy comes after Mylan was criticised regarding the rising price of EpiPen (epinephrine), prompting the drugmaker to offer an authorised generic version of the therapy. Additionally, CVS Health in January announced plans to offer Impax Laboratories' Adrenaclick (epinephrine) at a cash price 80 percent lower than Mylan's EpiPen. Meanwhile, Kaléo re-launched its epinephrine auto-injector Auvi-Q earlier this year. 

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Commenting on the news, Maxim analyst Jason Kolbert, who estimated that Symjepi will be launched by the middle of the summer, noted that Adrenaclick is "unlikely to set the pricing of the marketplace as [Symjepi] enters," noting that Adrenaclick is an older product. Kolbert stated Symjepi "may actually be a better, more user-friendly product [design-wise] versus EpiPen, Adrenaclick and Auvi-Q." 

Kolbert continued "the market opportunity is large," adding "even with just moderate market share assumptions, [Symjepi] becomes a significant product." Meanwhile, Carlo disclosed that Adamis is also developing a "junior" version of the drug. 

The FDA declined to clear the therapy last year and directed Adamis to conduct additional testing. 

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