IntelGenx Receives FDA GDUFA Date for Development Candidate Buprenorphine Buccal Film in Partnership with Xiromed, The Canadian Business Journal

SAINT LAURENT, Quebec, Oct. 25, 2022 (GLOBE NEWSWIRE) — IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the “Company” or “IntelGenx”) today announced a formerly private development candidate A buprenorphine buccal film has been published. ‘s Abbreviated New Drug Application (“ANDA”) has been submitted by Chemo Research SL (“Chemo”) through its agent and affiliate, Xiromed LLC (“Xiromed”), to the U.S. Food and Drug Administration (“FDA”) has received the approval of ) Generic Drug Fee Act (“GDUFA”) date of April 28, 2023.

Buprenorphine Buccal Film is the generic version of Verbuca.^®is an opioid used to manage pain severe enough to require long-term, 24/7 opioid treatment when other pain treatments are inadequate. Belbuca, approved by the FDA in 2015^® It is applied to the oral or buccal mucosa every 12 hours and comes in 7 concentrations ranging from 0.075 mg to 0.9 mg.

IntelGenx partnered with Chemo, part of Insud Pharma Group, to develop buprenorphine buccal film in September 2016. Buprenorphine buccal film incorporates his VersaFilm from IntelGenx.^® New formulation technology. The two companies co-developed his ANDA, a candidate currently under FDA review.

“We are pleased to announce that our long-term partnership with Xiromed has resulted in this regulatory submission to the FDA, with review expected to be completed early in the second quarter of next year,” said Horst, CEO. Dr. G. Zerbe comments. Intel Genx. “Generic version of Bellbuca^® Designed to be a bioequivalent, low-cost alternative for patients. We look forward to the FDA’s decision and, if positive, to commercialize our buprenorphine buccal film as soon as possible. “

According to IMS Health, a leading healthcare data and analytics provider, Belbuca’s global annual sales are^® Reached $315 million as of July 2022.

About Xyromed

Located in Florham Park, New Jersey, Xiromed LLC is the US generics division of Insud Pharma, SL, a global pharmaceutical group headquartered in Madrid, Spain. Xiromed is focused on the development and commercialization of high quality generic medicines for the US market. In addition to our commercial portfolio of generics available in the US, Xiromed has a strong development portfolio of generics in various stages of development, including injectables, inhalers and complex generics. For more information, please visit http://www.xiromed.com/usa/.

About Intel Genx

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

Superior film technology from IntelGenx including VersaFilm^®DisinteQ^™VetaFilm^™ and transdermal VevaDerm^™, enabling next-generation medicines that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians across many therapeutic conditions.

IntelGenx’s highly skilled team provides pharmaceutical partners with comprehensive pharmaceutical services including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility provides full service by offering lab-scale to pilot-scale and commercial-scale production. For more information, please visit www.intelgenx.com.

Forward-Looking Information and Statements

This document may contain forward-looking information regarding IntelGenx’s performance 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 regarding IntelGenx’s plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances. Expressions such as “intend”, “plan”, “believe”, “seek”, “estimate”, “could”, “would”. All forward-looking statements are qualified in full and expressly by this cautionary statement. These forward-looking statements are subject to a number of risks and uncertainties that may cause IntelGenx’s actual results to differ materially from those expressed or implied by these forward-looking statements. . Factors that may cause or contribute to such differences are filed with the U.S. Securities and Exchange Commission and with the Canadian securities regulators at www.sedar.com. . IntelGenx does not undertake any obligation to update such forward-looking statements.

sauce: Intel Genx Technologies Corp.

For IntelGenx:

Stephen Kilmer
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(647) 872-4849
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or

Andre Godin, CPA, California
President and CFO
Intel Jenks
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