IntelGenx Receives Complete Response Letter from FDA for RIZAPORT® NDA
SAINT LAURENT, Quebec, March 27, 2020 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, today announced that it has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“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.
“Obviously, we are surprised and disappointed,” said Dr. Horst G. Zerbe, CEO of IntelGenx. “We are committed to addressing the concerns raised by the FDA in the CRL. To that end, we will request a meeting with the Agency as soon as reasonably possible to discuss the scope of the CRL comments to obtain clarification and determine next steps.”
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' 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. IntelGenx assumes no obligation to update any such forward-looking statements.
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Source: IntelGenx Technologies Corp.
(514) 331-7440 ext 232
Andre Godin, CPA, CA
President and CFO
(514) 331-7440 ext 203
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