Sanofi abandoning Auvi-Q after dosage problems led to total recall

23-Feb-2016 - Last updated on 24-Feb-2016 at 08:44 GMT

Auvi-Q: Epinephrine Injection. Image c/o Sanofi

Sanofi is poised to terminate its Auvi-Q marketing deal says PDL Biopharma, citing manufacturing issues last year which led to a complete recall of the epinephrine injection product.

Auvi-Q (epinephrine injection) – known as Intelliject in Canada – is used to treat patients experiencing serious allergic reactions. It was licensed by French pharma giant Sanofi from Kaléo in 2009 in a deal worth around $230m (€210m).

But last October, production was halted and a mass recall instigated after a number of suspected device malfunctions relating to the accuracy of the dosage being delivered were reported.

Sanofi said at the time the recall could have a negative impact of around €100m ($110m). Earlier this month the French drugmaker attributed a 1.6% year-on-year drop in fourth quarter sales to Auvi-Q’s problems.

But announcing its own fourth quarter financials yesterday, PDL Biopharma said: "On February 18, 2016, PDL was advised that Sanofi and Kaléo will terminate their license and development agreement later this year. At that time, all US and Canadian commercial and manufacturing rights to Auvi-Q will be returned to Kaléo."

Repaying and Restarting Production

Kaléo owes PDL around $145m in loan repayments from two financing deals backed by royalty payments from Auvi-Q.

PDL's CEO John McLaughlin said Kaléo has the ability to manufacture and commercialise the product itself, although the details of how this would be done is unclear (transcript here).

“They have their own manufacturing line to produce [a second product, Evzio (naloxone)], whether they are going to switch it over in their manufacturing line, take over their manufacturing line or assume the manufacturing line the contract manufacturer has been making for Sanofi, we don’t have any insights on that and we don’t know…”

“So how they are going to do it was they are going to build it all out or license it back out for some parts of it. It’s just too soon to tell. As we indicated, we got this notice on February 18. So, it’s kind of live theatre.”

In-Pharmatechnologist.com contacted both Kaléo and Sanofi for more comment, but neither responded at the time of going to press.

Auvi-Q will become the second product abandoned by Sanofi this year. In January, the firm announced it was exiting its commercialisation agreement with MannKind for the inhaled insulin product Afrezza following ten months of low sales.