IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx"), a leading oral drug delivery company, today announced that it has entered into a definitive worldwide agreement with Aquestive Therapeutics, Inc. (NASDAQ:AQST) ("Aquestive"), a specialty pharmaceutical company focused on developing and commercializing differentiated products to solve therapeutic problems, for the co-development and commercialization of Tadalafil oral films (the "Agreement") for the treatment of erectile dysfunction ("ED").
Under the terms of the Agreement, 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 Dr. Horst G. Zerbe, President and CEO of 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."
"IntelGenx is a natural partner for our tadalafil oral film program," said Dan Barber, Chief Operating Officer of Aquestive. "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. Food and Drug Administration ("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.
About Aquestive Therapeutics
Aquestive Therapeutics is a specialty pharmaceutical company that applies innovative technology to solve therapeutic problems and improve medicines for patients. Aquestive is advancing a late-stage proprietary product pipeline to treat CNS conditions and provide alternatives to invasively-administered standard of care therapies. The company also collaborates with pharmaceutical partners to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven capabilities for drug development and commercialization. For more information about the company, please visit www.aquestive.com.
About IntelGenx
Established in 2003, IntelGenx is a leading oral drug delivery company primarily focused on the development and manufacturing of innovative pharmaceutical oral films based on its proprietary VersaFilm™ and VetaFilm™ technology platforms.
IntelGenx's highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx's state-of-the-art manufacturing facility, which was established for oral film technology platforms, offers by supporting lab-scale to pilot- and commercial-scale production. More information about the company can be found at www.intelgenx.com.
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