The US firm announced it would relaunch Auvi-Q early next year. The product – which is used to treat severe allergic reactions – was recalled last November over concerns it could potentially deliver the incorrect dose.
Sanofi handed back rights to the product to Kaleo in February and terminated a co-marketing deal it had with PDL Biopharma.
Kaleo also said it had taken over production from Sanofi, adding that it conducted “a thorough manufacturing assessment and invested in new technology and quality systems to ensure accurate, reliable and consistent delivery from the product.”
Auvi-Q is a rival for Mylan NV’s EpiPen, the price of which has increased dramatically in recent years.
According to a House Committee on Oversight and Government Reform hearing in September Mylan’s Epipen increased 500 percent in the last decade, rising from $100 to more than $600.
Kaleo said it “is aware of the epinephrine auto-injector access and affordability challenges confronting patients” adding that it is working with various stakeholders to ensure that “all patients regardless of insurance coverage, have affordable access to Auvi-Q.”
Spokesman Sam Schwartz declined to say how much Kaleo will charge for Auvi-Q, b ut did say "our goal is that any patient who needs an epinephrine auto-injector, regardless of insurance coverage, should have affordable access to AUVI-Q."
Kaleo may not be the only company to launch an Epipen rival.
When the US FDA rejected a generic version of the product developed by Teva in February, the firm said it “expects that its epinephrine product will be significantly delayed and that any launch will not take place before 2017.”