IntelGenx Receives FDA GDUFA Date for Xiromed-Partnered Development Candidate, Buprenorphine Buccal Film
IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) announced on October 25, 2022, the submission of an ANDA for its Buprenorphine Buccal Film, developed in partnership with Chemo Research. The FDA has set a GDUFA date of April 28, 2023, for review. This product is a generic version of Belbuca®, designed for long-term pain management. With global annual sales of Belbuca® reaching $315 million as of July 2022, IntelGenx aims to offer an affordable alternative. The company looks forward to a favorable FDA decision and potential commercialization of the product.
- Development of Buprenorphine Buccal Film as a generic version of Belbuca® offering cost-effective pain management.
- FDA filing indicates progression towards potential market entry with a GDUFA date of April 28, 2023.
- Partnership with Chemo Research may enhance product development and commercialization capabilities.
- None.
SAINT LAURENT, Quebec, Oct. 25, 2022 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that its previously undisclosed development candidate, Buprenorphine Buccal Film, for which an abbreviated new drug application (“ANDA”) has been filed by Chemo Research SL (“Chemo”) through its agent and affiliate Xiromed LLC (“Xiromed”), has received a U.S. Food and Drug Administration (“FDA”) Generic Drug User Fee Act (“GDUFA”) date of April 28, 2023.
Buprenorphine Buccal Film is a generic version of Belbuca®, an opioid that is used to manage 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 mg to 0.9 mg.
IntelGenx partnered with Chemo, part of the Insud Pharma Group, on the development of Buprenorphine Buccal Film in September 2016. Buprenorphine Buccal Film incorporates IntelGenx’s VersaFilm® technology in a novel formulation. The companies co-developed the candidate’s ANDA that is currently under review by the FDA.
“We are pleased that our long-term partnership with Xiromed has resulted in this regulatory filing with the FDA, which has indicated that it will complete its review early in the second quarter of next year,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “Our generic version of Belbuca® is designed to be a bioequivalent, lower-cost alternative for patients. We are looking forward to the FDA’s decision and, assuming a positive outcome, the commercialization of Buprenorphine Buccal Film as soon as possible.”
According to IMS Health, a leading healthcare data and analytics provider, global annual sales of Belbuca® amounted to
About Xiromed
Xiromed LLC, located in Florham Park, NJ, is the US generic division of Insud Pharma, S.L., a global pharmaceutical group headquartered in Madrid, Spain. Xiromed is focused on developing and commercializing high quality generic pharmaceutical products for the US market. In addition to its commercial portfolio of generics available in the US, Xiromed has a robust development portfolio of generic pharmaceutical products in various stages of development, including injectable, inhalation and complex generic products. Learn more at http://www.xiromed.com/usa/.
About IntelGenx
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 R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx's state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.
Forward-Looking Information and 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.
Source: IntelGenx Technologies Corp.
For IntelGenx:
Stephen Kilmer
Investor Relations
(647) 872-4849
stephen@kilmerlucas.com
Or
Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com
FAQ
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