IntelGenx and Aquestive Therapeutics in global collaboration for Tadalafil
Under the accord, 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 also will jointly undertake further co-development and commercialization of Tadalafil oral film products, and will share on 50/50 basis net profits from worldwide product sales.
Aquestive previously submitted an NDA for its tadalafil oral film for the treatment of ED to the FDA. In November 2018, Aquestive received a complete response letter (CRL) from the FDA, requesting limited additional data from healthy volunteers. IntelGenx and Aquestive both will cooperate in responding to the CRL.
“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,” Dr. Horst Zerbe, president and CEO of IntelGenx, said in a statement.
“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,” he added.
Dan Barber, COO of Aquestive, said IntelGenx is a natural partner for the company’s 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,” he added.