Aquestive offloads film formulation seizure drug to Assertio, securing cash for epinephrine R&D

Specialty pharma company Assertio Holdings has expanded its portfolio through a deal with Aquestive Therapeutics, paying $9 million upfront for exclusive rights to the Sympazan oral film formulation.

Sympazan is a formulation of clobazam, a benzodiazepine class medication, that is authorized to treat seizures associated with Lennox-Gastaut syndrome. The product uses Aquestive’s PharmFilm to provide an alternative to pill and liquid formulations of clobazam. Patients put the film on the tongue, where it dissolves without the use of water. 

Aquestive generated revenues of $9.5 million from Sympazan over the past 12 months but has decided it is best served by cashing in. The sale is part of a push to access non-dilutive financing to support work on the epinephrine sublingual film AQST-109.

Exactly how much Aquestive receives in return for Sympazan depends on an upcoming patent decision. Assertio is paying $9 million upfront but, with the last existing patent set to expire in April 2024, will only pay more if additional intellectual property protection is secured. Aquestive has filed a patent that could extend protection out to 2039. If the patent is allowed, Assertio will pay a further $6 million. 

Assertio is buying Sympazan as part of its push to acquire $40 million in gross profit by 2024. Dan Peisert, president and CEO of Assertio, set out the appeal of the film formulation in a statement to disclose the deal. 

“Sympazan can offer benefits to its prescribed population, such as dosing through its oral film technology. For many LGS patients, severely restricted carbohydrate diets, such as keto, are an important treatment approach. Unlike other forms of clobazam, Sympazan has very low carbohydrate content, which aligns to this important treatment recommendation,” Peisert said.