Privately held drugmaker Kaleo Inc announced on Wednesday plans for a U.S. relaunch of its Auvi-Q injector for life-threatening allergic reactions in the first half of next year.
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Auvi-Q, designed to deliver the same epinephrine drug as Mylan NV's EpiPen, was recalled from the market last year amid concerns about accuracy of the dosage delivered.
French pharmaceutical company Sanofi SA had licensed and made Auvi-Q, but it returned rights to the product to Kaleo in February after the recall.
Mylan has come under fire from lawmakers and consumer groups for raising the list price for a pair of EpiPens to more than $600 this year from $100 in 2007 when Mylan acquired the product.
Mylan said last month it plans to launch, at a list price of $300, its own generic EpiPen by the end of this year.
Officials at Kaleo declined to comment on a planned list price for the relaunched Auvi-Q.
"We are working on what is the right price to assure that the ultimate patient co-pay is low," Kaleo Chief Executive Officer Spencer Williamson told Reuters in a telephone interview.
Unlike the pen-shaped EpiPen, Auvi-Q, which includes a voice prompt system to guide users, is the length and width of a credit card with the thickness of a small cellphone.
The Kaleo device also has a needle that automatically retracts after the device has been used.
Williamson said Auvi-Q will be manufactured at an automated robotic production line located in the Midwestern United States.
Kaleo also sells Evzio, a hand-held device designed to automatically deliver a set dose of naloxone, a drug approved to treat an overdose of opioid painkillers.
Evzio has a current list price of $3,750 for two active devices and one training device.
By Deena Beasley