SAINT LAURENT, Quebec, Sept. 26, 2019 (GLOBE NEWSWIRE) -- IntelGenx Corp. (IGX.V)(IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, today announced that it has resubmitted its 505(b)(2) New Drug Application (“NDA”) for RIZAPORT® VersaFilm® for the treatment of acute migraines to the U.S. Food and Drug Administration (“FDA”).
“Over the past several months, we have been working diligently to address the FDA’s questions and resubmit this NDA in a timely manner,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “I am pleased with our team’s hard work to resubmit this NDA as planned, and we are looking forward to continuing to work with the FDA to make this innovative migraine treatment available to patients.”
On April 2, 2019, the Company announced that it had received a Complete Response Letter (“CRL”) from the FDA regarding the NDA for RIZAPORT® VersaFilm® accepted by the Agency on November 20, 2018. The issues cited in the CRL relate to the Chemistry, Manufacturing and Controls section of the application. The FDA requested additional information, but no new bioequivalence study.
The resubmitted NDA is subject to the FDA’s acceptance review, the results of which are expected within 30 days.
IntelGenx 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 offer 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'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.
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Source: IntelGenx Technologies Corp.
For more information, please contact:
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Andre Godin, CPA, CA
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