IntelGenx and Aquestive Therapeutics Enter Worldwide Collaboration Agreement for Tadalafil

May 08, 2019

SAINT LAURENT, Quebec, May 08, 2019 (GLOBE NEWSWIRE) -- 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.

Forward Looking Statements

This document may contain forward-looking information about IntelGenx's operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx's plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words "may," "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "could," "would," and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx's actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading "Risk Factors" in IntelGenx's annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.

Each of the TSX Venture Exchange and OTCQX has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Source:  IntelGenx Technologies Corp.

 

For IntelGenx

Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
stephen@intelgenx.com

Or

Andre Godin, CPA, CA
Executive Vice-President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com

For Aquestive

Media inquiries:
Christopher Hippolyte
212-364-0458
christopher.hippolyte@syneoshealth.com

Investor inquiries:
Stephanie Carrington
646-277-1282
stephanie.carrington@icrinc.com

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Source: IntelGenx Technologies Corp.