Oral drug delivery company, IntelGenx, has entered into a definitive worldwide agreement with Aquestive Therapeutics for the co-development and commercialization of Tadalafil oral films for the treatment of erectile dysfunction (ED).
 
IntelGenx and Aquestive will each grant to the other exclusive worldwide licenses to their respective intellectual property relating to tadalafil oral film formulation and manufacturing. The companies will jointly undertake further co-development and commercialization of Tadalafil oral film products, and will equally share (50/50) net profits from worldwide product sales. In connection with the agreement, Aquestive has also granted a non-exclusive, royalty bearing U.S. license to any of its intellectual property that may relate to the formulation and manufacturing of IntelGenx’s rizatriptan oral film product, Rizaport. IntelGenx will pay Aquestive a royalty equal to 10% of all payments received by IntelGenx from third parties for U.S. product related milestones and sales
 
“We are pleased to collaborate with Aquestive given the synergy of our oral film technologies, particularly pertaining to the development and commercialization of tadalafil oral films,” said Horst Zerbe, president and chief executive officer, IntelGenx. “The launch of a partnered tadalafil oral film in the U.S. has the potential to bring a product to market sooner and maximize the commercial opportunity for IntelGenx, Aquestive, and our respective shareholders.”
 
Dan Barber, chief operating officer, Aquestive, said, “IntelGenx is a natural partner for our tadalafil oral film program. This partnership will allow us to continue to stay focused on advancing our commercial portfolio and late stage CNS programs, while working with IntelGenx to realize the full potential for tadalafil oral film on a global basis. We are also pleased to provide access to our extensive intellectual property portfolio for IntelGenx’s Rizaport product.”
 
Aquestive previously submitted new drug application (NDA) for its tadalafil oral film for the treatment of ED to the U.S. FDA. In November 2018, Aquestive received a complete response letter (CRL) from the FDA requesting limited additional data from healthy volunteers. Under the terms of the Agreement, both companies will cooperate in responding to the FDA’s CRL.