(CNSNews.com) – Kaléo, a privately-held pharmaceutical company based in Richmond, Virginia, announced plans on Wednesday to reintroduce its AUVI-Q epinephrine auto-injector, a prescription used to treat life-threatening allergies, to the U.S. market next year to compete with Mylan Pharmaceutical’s $600 Epipen.
“We believe that patients should have options when it comes to epinephrine auto-injectors for life-threatening allergic reactions,” said Spencer Williamson, president and CEO of Kaléo.
“When a health care practitioner prescribes AUVI-Q, determining that it is best for a patient, we believe that the patient should be able to obtain the product without insurance barriers or being subjected to a high out-of-pocket cost.
"As we prepare to make AUVI-Q available once again in the United States, our priority is to return AUVI-Q to the market as an epinephrine auto-injector alternative that all patients can afford,” Williamson continued.
However, Kaléo has declined to comment on how much the new AUVI-Q auto-injector, which will be available during the first half of 2017, will cost.
Both the AUVI-Q and the Epipen release the drug epinephrine to reverse the effects of severe allergic reactions, which can include low blood pressure and impaired breathing.
The auto-injector market had previously been exclusive to Mylan Pharmaceutical’s Epipen, which acquired the rights to the product in 2007.
But Mylan - whose CEO, Heather Bresch, is also the daughter of Sen. Joe Manchin (D-WV) - received public backlash back in May when the company raised the price of Epipens 500 percent, from $100 to $608 for a pack of two pens.
Mylan responded to the criticism by releasing a cheaper, generic version of the Epipen for about $300 for two pens.
AUVI-Q auto-injectors were invented by Evan and Eric Edwards, twins suffering from severe food allergies, licensed to French pharmaceutical company Sanofi, and released to the public in 2013 as a slimmer, pocket-friendly version of the Epipen complete with audio instructions.
But they were recalled by Sanofi last October following reports that the product malfunctioned or contained insufficient doses for users experiencing severe allergic reactions.
Kaléo regained the rights to the AUVI-Q in February after its partnership with Sanofi was terminated due to the recall, which Williamson said was due to a “manufacturing process issue.”
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