Auvi-Q Auto-Injector Relaunch Being Planned, Kaléo CEO Says

in Food Allergy, Food Allergy News, Inside Food Allergy
Published: April 7, 2016

auviQAuvi-Q may be returning to the market, the device's developers hinted recently.
Kaléo, the developer of the Auvi-Q epinephrine auto-injector appears to be planning the return of its “talking” device to market.

The Virginia-based company recently regained the rights to the auto-injector from Sanofi US following a full device recall in the fall of 2015. “We now own the product. We are in the process of figuring out when and how best to bring Auvi-Q back to the market,” Spencer Williamson, president and CEO of Kaléo, said in a recent interview with the Richmond Times-Dispatch.

While it’s not clear whether any product issues that led to the recall of all Auvi-Q devices (and Allerject in Canada) have been resolved or when the product might be available again or who will manufacture it, Williamson sounded a note of optimism.

“It is a huge market, and it’s a market where we continue to get emails and phone calls from patients, from physicians, from advocacy groups asking, begging us, to bring the product back. So we’re working very quickly on how best to do that, how quickly we can do that,” he told the Times-Dispatch.

Kaléo declined an Allergic Living request for an interview with one of its principals at this time. But Mark Herzog, vice-president of corporate affairs for Kaléo, did echo his CEO’s comments via email.

He wrote that the company is “currently in the process of evaluating the timing and options for how best to make Auvi-Q/Allerject available again to patients and their family members.”

While the royalties from Sanofi were worth tens of millions to Kaléo (depending upon sales), even without that revenue, Williamson told the Times-Dispatch that his private company is “blessed to be in a strong financial position.”

Kaléo has developed another auto-injection product (called Evzio) for opioid overdoses, and the CEO described it as “growing at a very attractive trajectory.”