Kaléo's EpiPen competitor to return to US market

Kaléo, a privately-held US pharmaceutical company, has said it will reintroduce Auvi-Q (epinephrine injection, USP) auto-injector to the US market in the first half of 2017.

Auvi-Q is a prescription medicine used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions, which was previously marketed for Kaléo by Sanofi, but was pulled in late 2015 due to problems with the injection mechanism.

Auvi-Q will again compete with the EpiPen Auto-Injector (epinephrine injection, USP) from Mylan (Nasdaq: MYL), which has suffered a barrage of criticism and congressional investigations for its exorbitant pricing. Mylan itself has said it will bring a generic version to the US market at a list price of $300 per generic EpiPen two-pack carton. This represents a discount of more than 50% to the Mylan list price, or wholesale acquisition cost (WAC), of the branded medicine. Mylan’s shares were off 1.55% at $38.08 by close of trading yesterday.