EpiPen Competitor Will Re-Launch After Being Pulled Off Marketby
Kaleo says it hasn’t settled on pricing for the device
Auvi-Q was previously recalled for suspected malfunctions
Mylan NV’s dominance of the U.S. allergy-shot market will be challenged next year as drugmaker Kaleo Inc. says it will resume sales of a competing product that was recalled last year.
Kaleo’s injector, called Auvi-Q, was recalled from U.S. sales about a year ago over potential malfunctions that could give patients the wrong dose of drug. Closely-held Kaleo said in a statement Wednesday that the shot will return to the market in the first half of 2017. It hasn’t settled on a price, said Chief Executive Officer Spencer Williamson in a phone interview.
“We’re working with multiple stakeholders including wholesalers, pharmacy benefit managers, insurers, etc., to establish a comprehensive access program,” he said. “We’re focused on minimizing the out-of-pocket costs for the patient.”
Kaleo’s announcement comes as Mylan has been under fire for the price of its EpiPen product, which is used to counteract life-threatening anaphylactic reactions. EpiPen’s wholesale price has jumped sixfold since 2007 to list for about $600 for a two-pack.
Auvi-Q was originally marketed by French pharmaceutical giant Sanofi. Launched in the U.S. in January 2013, the injector was pulled from the market in October 2015 over suspected malfunctions resulting in inaccurate dosage delivery. No patients died because of the issues with the device. Four months later, Sanofi said it was ending the partnership with Richmond, Virginia-based Kaleo, and giving it back the rights to the device.
Since Kaleo regained control of the product, it’s also taken over manufacturing, which Sanofi was previously in charge of, said Eric Edwards, vice president of product strategy. Edwards, who suffers from life-threatening food allergies, invented the product with his twin brother, who is also a sufferer.
“We have implemented a proven manufacturing and quality system that can be relied upon,” said Edwards. “It’s personal for us. You can be confident that we take it very, very seriously to have flawless manufacturing.”
The FDA had not pulled the product’s regulatory approval, so Kaleo is free to relaunch the allergy shot when it feels ready to do so, said CEO Williamson.
Even when it was on the market, Auvi-Q struggled to gain market share. In the first half of 2015, EpiPen had about an 85 percent share of epinephrine prescriptions compared to 10 percent for Auvi-Q, according to Symphony Health Solutions data compiled by Bloomberg.
Other competitors have also suffered setbacks. A proposed generic version of EpiPen made by Teva Pharmaceutical Industries Ltd. was rejected by the FDA earlier this year. Teva told investors it would respond to the FDA, but expected the launch to be “significantly delayed.” Adamis Pharmaceuticals Corp. also had its version rejected by the agency in June. Mylan has said it will introduce its own “authorized generic” version at $300 for a two-pack.
Unlike the EpiPen, Auvi-Q is roughly the shape and size of a deck of cards, and comes with pre-recorded audio instructions that can assist patients by talking through the step-by-step use of the device.