Mr. Dwight Gorham reports

INTELGENX PROVIDES REGULATORY UPDATE FOR XIROMED-PARTNERED DEVELOPMENT CANDIDATE, BUPRENORPHINE BUCCAL FILM

IntelGenx Corp. has provided a regulatory update on buprenorphine buccal film, for which an abbreviated new drug application (ANDA) has been filed with the U.S. Food and Drug Administration by its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC.

As previously announced, Xiromed received a complete response letter (CRL) from the FDA in April, 2023. In response to the CRL, Xiromed submitted to the FDA an amendment to the ANDA, requesting priority review. In an amendment acknowledgment received from the FDA by Xiromed, the FDA granted priority review with a Generic Drug User Fee Act (GDUFA) goal date for review of the amendment of March 8, 2024, unless the agency determines that an inspection is required. Alternatively, if the FDA determines that an inspection is required, the GDUFA goal date is July 8, 2024.

"We are pleased with our partner Xiromed's prompt and fulsome response to the CRL, and are looking forward to the agency's decision," commented Dwight Gorham, IntelGenx's chief executive officer. "Given the recent preapproval inspection in March, 2023, and subsequent approval of our rizatriptan oral film, we are optimistic that the FDA will decide to review this amendment without the need for an additional inspection of our facility."

About buprenorphine buccal film

Buprenorphine buccal film, which incorporates IntelGenx's VersaFilm technology in a novel formulation, is a generic version of Belbuca, an opioid that is used to manage chronic pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments are inadequate. Approved by the FDA in 2015, Belbuca is applied to the oral or buccal mucosa every 12 hours and comes in seven strengths ranging from 0.075 milligram to 0.9 milligram.

About IntelGenx Corp.

IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

IntelGenx's superior film technologies, including VersaFilm, DisinteQ, VetaFilm and transdermal VevaDerm, allow for next-generation pharmaceutical products that address unmet medical needs. IntelGenx's innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions.

IntelGenx's highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including research and development, analytical method development, clinical monitoring, intellectual property, and regulatory services. IntelGenx's state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production, as well as other CDMO (contract development and manufacturing organization) services.

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