IntelGenx Provides Update on RIZAPORT® VersaFilm® NDA Resubmission Process Following Type A Meeting with the FDA
SAINT LAURENT, Quebec, June 11, 2020 (GLOBE NEWSWIRE) — Saint Laurent, Quebec, June 11, 2020 – IntelGenx Corp. (TSX V:IGX)(OTCQB:IGXT) (the “Company” or “IntelGenx”) today provided an update regarding its RIZAPORT® VersaFilm® program following its Type A meeting with the U.S. Food & Drug Administration (“FDA”) that took place on June 10, 2020.
On March 27, 2020, IntelGenx received a Complete Response Letter (“CRL”) from the FDA regarding its resubmitted 505(b)(2) New Drug Application (“NDA”) for RIZAPORT® VersaFilm® for the treatment of acute migraines. The CRL states that the FDA cannot approve the application in its present form. The Agency requested additional information, but no new bioequivalence study.At the meeting, IntelGenx obtained clarity from the Agency on the Chemistry, Manufacturing and Controls (CMC) information required for resubmission of the NDA.“The Type A meeting with the FDA was very productive and we are pleased with the outcome,” said Dr. Horst G. Zerbe, CEO of IntelGenx. “We are looking forward to completing the work required to resubmit our RIZAPORT® VersaFilm® NDA and remain committed to making this innovative new oral film product available to people suffering from migraines. We look forward to providing further updates on our progress as developments unfold.”About IntelGenxIntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.IntelGenx’s superior film technologies, including VersaFilm®, VetaFilm™ and transdermal, 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 Statements:This document may contain forward-looking information about IntelGenx’ 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’ 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’ 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’ 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. In addition, there is uncertainty about the spread of the COVID-19 virus and the impact it will have on IntelGenx’s operations, the demand for its products, global supply chains and economic activity in general. IntelGenx assumes no obligation to update any such forward-looking statements.Each of the TSX Venture Exchange and OTCQB 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
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