The developer of the Auvi-Q, a previously failed competitor to the EpiPen, will bring back the “talking” epinephrine auto-injector to the market in the first half of 2017, amid public backlash against EpiPen maker Mylan.
Richmond, Va.-based Kaléo, plans to redevelop the product after terminating its licensing agreement with France-based Sanofi in February. Sanofi recalled the Auvi-Q in 2015 after it repeatedly delivered inaccurate doses to patients, and the product never returned to the market.
The Auvi-Q, which was launched by Sanofi in January 2013, has a voice prompt system that talks its user through the process of delivering epinephrine in a manner somewhat similar to the EpiPen. Since the downfall of the product, privately held Kaléo has developed a similar device that delivers naloxone, the emergency drug that can temporarily reverse the effects of opioid overdoses.
The Auvi-Q is an innovator drug, not a generic version of the EpiPen, which is designed differently. Mylan didn't return a request for comment.
Kaléo says it conducted a manufacturing assessment and has invested in new technology and quality systems to ensure that the device works as it should. The product is made on a robotic assembly line that is entirely automated and includes over 100 quality checks for each product, the company said.
In its announcement Wednesday, Kaléo acknowledged the “access and affordability challenges” that EpiPen patients have encountered, and said it is working with wholesalers, insurers, pharmacies and pharmacy benefit managers to ensure that patients have affordable access. A lack of serious competition to the EpiPen has allowed Mylan to continually increase its prices to the current list price of $608.
Kaleo CEO Spencer Williamson said in a statement that the company isn't yet ready to release information about the Auvi-Q's cost, but will be implementing a “comprehensive access program.” Williamson also said that it has taken significant steps to ensure that the product works properly.
“Every component built into each AUVI-Q has an identifier and is tracked throughout the manufacturing process,” Williamson said. “We are committed to the highest quality manufacturing processes and systems and want to make sure that our product works every time.”
The need for 100% reliability in the event of an anaphylactic attack is a major reason why other manufacturers have failed to compete with EpiPen or have been dissuaded from entering the market.
Mylan stock dropped 1.5% to about $38.09 a share following the news Wednesday morning, but later rebounded slightly. Media reports suggest that Auvi-Q had about a 10% market share when it was available to patients.
Israel-based Teva Pharmaceutical Industries has been trying to get approval from the Food and Drug Administration for a generic version of the EpiPen, but so far as been unsuccessful, in part due to Mylan's petitioning against the product. Following public backlash about its pricing strategies, Mylan has expanded its discount programs and pledged to introduce a generic version.