After Kaléo unveiled a “redesign” of the in-office commercial team for its EpiPen rival Auvi-Q at the start of the month, the privately held company has announced a fresh round of job cuts in the U.S.
As part of a “mass layoff” of sales representatives, Kaléo will lay off a total of 58 employees across the country, according to a Worker Adjustment and Retraining Notification (WARN) alert filed (PDF) with the state of Ohio last week. Eight of those employees—described as remote workers by local news outlet Richmond Biz Sense—hail from Kaléo’s home state of Virginia.
The layoffs, slated to start taking effect in late November, also include staff reductions in states like Iowa, Michigan and Massachusetts.
Kaléo did not immediately respond to Fierce Pharma’s request for comment on the decision.
News of the layoffs come shortly after Kaléo on Oct. 1 said it was retooling its commercial team for its lead product Auvi-Q in a bid to “increase in-office support for healthcare providers.” The move is expected to double the number of in-office representatives and will also see an expansion to Kaléo’s pharmacy support team, the company’s CEO, Michael Wells, said at the time.
Auvi-Q is a bespoke epinephrine drug-device combo that competes directly with Mylan’s ubiquitous EpiPen. Mylan in November 2020 joined forces with Pfizer’s Upjohn unit to form the new company Viatris.
After Auvi-Q first hit the market in 2013, the autoinjector had trouble gaining traction, prompting Kaléo to strike a commercial agreement with Sanofi. Sanofi ultimately suffered production problems that led to a nationwide recall of the anaphylaxis rescue medication.
Kaléo relaunched Auvi-Q in 2016 at an increased price that drew media attention and the ire of Congress. The company subsequently won an expanded FDA approval for Auvi-Q to treat life-threatening allergic reactions in infants and small children in late 2017.
Auvi-Q has presented problems for Kaléo over the past year.
Following the U.S. Federal Trade Commission’s crackdown on improper patents in the FDA’s Orange Book last year, Kaléo delisted eight patents around its drug-device combo in the FDA’s database.
Companies like GSK, Amneal, AstraZeneca and Teva were also targeted in the improper patent purge.
More recently, Kaléo took flak from the FDA for its promotional ties to Brittany Mahomes after the sports team co-owner and wife of NFL quarterback Patrick Mahomes posted to her Instagram account in a paid partnership with Auvi-Q.
The FDA claimed Mahomes’ post was false or misleading because it discussed the benefits of Kaléo’s epinephrine product without adequately detailing “any risk information about the drug.”