IntelGenx Announces Resubmission of RIZAPORT® New Drug Application
September 26 2019 - 4:34PM
IntelGenx Corp. (TSX-V:IGX)(OTCQX: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.
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®, 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.
Each of the TSX Venture Exchange and OTCQX 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 more information, please
contact:
Stephen KilmerInvestor Relations (514) 331-7440
ext 232stephen@intelgenx.com
Or
Andre Godin, CPA, CAPresident and CFOIntelGenx
Corp.(514) 331-7440 ext 203andre@intelgenx.com
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