Aquestive Therapeutics CEO Keith Kendall Departs After 20 Years
There is a changing of the guard at Aquestive Therapeutics. After nearly 20 years with the company, Keith Kendall, the current president, chief executive officer and board member, is departing Aquestive. He will be replaced by Daniel Barber, its current chief operating officer.
New Jersey-based Aquestive announced the leadership transition Tuesday afternoon. Kendall joined the company shortly after its 2004 launch as chief financial officer.
In 2011, Kendall was named co-president and chief operating officer and was appointed CEO in 2014. He led Aquestive through a significant growth stage during his tenure, including the approval of six different drugs by the U.S. Food and Drug Administration. The FDA wins include the approval of Exservan (riluzole oral film) for the treatment of amyotrophic lateral sclerosis, as well as the 2018 approval of Sympazan (clobazam) oral film for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients 2 years of age or older.
He also oversaw the development of a pipeline focused on treating diseases of the central nervous system and an earlier stage pipeline for the treatment of severe allergies, including anaphylaxis.
In its announcement, Aquestive did not specify if Kendall was retiring or if he was seeking new opportunities. Kendall will remain a consultant with the company through the end of the year and assist in the CEO transition, as well as the execution of the ongoing business strategy.
Santo Costa, chairman of the Aquestive Therapeutics Board of Directors, thanked Kendall for his service and contributions to the company.
“He guided Aquestive through extraordinary growth and built a corporate culture which will serve as a platform for continued future success of the company. We are pleased that Mr. Kendall will continue as an advisor to the Company and the senior management team through the end of the year. We wish him great success in his future endeavors,” Costa said.
Incoming CEO Daniel Barber expressed his own excitement about his next stage with the company. Since joining Aquestive in 2007, Barber said he has been involved in multiple facets of the business and will remain “keenly focused” on driving the company’s product candidates Libervant and AQST-109.
Aquestive is working with the FDA on the orphan drug review for its New Drug Application for Libervant, an inside the cheek soluble film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in epilepsy patients 12 years of age and older.
The FDA initially established a Dec. 23, 2021 PDUFA date for Libervant, but that was delayed due to the orphan drug review. Last month, the FDA issued a letter to Aquestive indicating that, at this time, it is unable to give a new PDUFA date while the review is ongoing, the company announced earlier this month in its quarterly financial report.
The other key asset for Aquestive is AQST-109, an orally delivered epinephrine-based product candidate for the emergency treatment of allergic reactions, including anaphylaxis. In March, the FDA granted Fast Track designation to AQST-109. In April, Aquestive reported positive topline results from the second part of the Phase I Epiphast study for AQST-109.
The second part of the trial confirmed the key pharmacokinetic and pharmacodynamic measures observed in part one of the study with a larger patient population. Part two of the study also confirmed the first-in-human pharmacokinetic study. In addition to positive pharmacokinetic results, AQST-109 demonstrated favorable pharmacodynamic effects on systolic blood pressure, diastolic blood pressure, and heart rate.