As the North American food allergy community is aware, Sanofi had ceased manufacture and recalled all unexpired Auvi-Q (and Allerject in Canada) devices in October 2015, citing reports of the possibility of incorrect dosage delivery in a small number of devices.
The exact details of how and when the transfer of rights from Sanofi to Kaléo will take place are still being determined, but the agreement between the two companies “will terminate later this year,” said Mark Herzog, Kaléo’s vice-president of corporate affairs, in a statement to Allergic Living on Feb. 23. “Sanofi is in discussions with Kaléo on these terms and for an orderly transition plan,” he said.
So does the Auvi-Q auto-injector have a future? All Herzog would say for now is, “Kaléo will evaluate timing and options for bringing Auvi-Q back to market.”
Kaléo investors PDL Biopharma sounded a note of optimism in a Feb. 22, 2016 conference call with financial analysts. CEO John McLaughlin said: “I think we are reasonably optimistic that [Auvi-Q] is a product that we will get back to market,” when he was asked what the transfer of the Auvi-Q rights to back to the inventors’ company might mean.
He noted on the conference call that Kaléo has an unrelated auto-injection device in production. But as to whether the Auvi-Q would be relaunched at all; produced in-house or licensed out, he said:
“It’s just too soon to tell. As we indicated, we got this notice on February 18. So, it’s kind of live theater.”