IntelGenx Announces FDA Approval of RIZAFILM® for the Treatment of Acute Migraine
17 April 2023 - 10:15PM
IntelGenx Corp. (TSX:IGX)(OTCQB:IGXT) (the "Company" or
"IntelGenx"), a leader in pharmaceutical films, today announced
that the U.S. Food and Drug Administration (“FDA”) has approved the
Company’s RIZAFILM® VersaFilm® 505(b)(2) new drug application (NDA)
for the treatment of acute migraine.1
RIZAFILM® (U.S. market name for RIZAPORT®) is a
proprietary oral thin film formulation of rizatriptan benzoate, the
active ingredient in Merck & Co.'s Maxalt®. The global migraine
drugs market was valued at nearly $3 billion in 2021 and is
expected to reach nearly $11 billion by 2030, representing a
compound annual growth rate of 15.6%.2
In December 2018, IntelGenx entered into a
definitive licensing, development and supply agreement with Gensco®
Pharma (“Gensco”) for the exclusive commercialization of RIZAFILM®
in the United States. Under the terms of the agreement, IntelGenx
is entitled to receive royalty payments based on net profits of
RIZAFILM®; and is eligible to receive pre-specified payments upon
the achievement of certain regulatory and commercial
milestones.
“Following a successful pre-approval inspection
by the FDA of our Montreal manufacturing facility earlier this
month, we are thrilled to reach this milestone and excited to soon
introduce what will be the first oral thin film for the treatment
of acute migraines available in the U.S.,” said Andre Godin,
IntelGenx’s President and CFO. “According to the American Migraine
Foundation, 39 million or 12% of Americans suffer from migraine,
which is the second leading cause of disability nationwide. We are
looking forward to working with our commercialization partner,
Gensco, to bring this innovative migraine therapeutic to patients
seeking convenient administration and quick relief from their pain.
In addition to these benefits, RIZAFILM® is well suited to the
approximately 80% of patients who have migraine-related nausea3, as
well as those who have difficulty swallowing.”
1 RIZAFILM® is a Registered Trademark of Gensco®
Pharma Corporation2 Reports and Data, Migraine Drugs Market,
https://www.reportsanddata.com/sample-enquiry-form/25153 Láinez
MJA. (2006) Rizatriptan in the treatment of migraine.
Neuropsychiatr Dis Treat. 2006 Sep; 2(3): 247–259
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 KilmerInvestor Relations(647)
872-4849stephen@kilmerlucas.com
Or
Andre Godin, CPA, CAPresident and CFOIntelGenx
Corp.(514) 331-7440 ext 203andre@intelgenx.com
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