IntelGenx Announces Receipt of Complete Response Letter from the FDA for Xiromed-Partnered Buprenorphine Buccal Film
April 27 2023 - 7:00AM
IntelGenx Corp. (TSX:IGX)(OTCQB:IGXT) (the "Company" or
"IntelGenx") today announced that its co-developer, Chemo Research
SL, through its agent and affiliate, Xiromed LLC (“Xiromed”), has
received a Complete Response Letter (“CRL”) from the U.S. Food and
Drug Administration (“FDA”) regarding the submitted abbreviated new
drug application (“ANDA”) for Buprenorphine Buccal Film. Xiromed
and IntelGenx will contact FDA to discuss the CRL and assess the
filing of a request for reconsideration of the CRL.
Andre Godin, IntelGenx’s President and CFO,
commented, “Our partner Xiromed has relayed to us that they plan to
promptly address the FDA’s concerns in the current quarter.”
Buprenorphine Buccal Film, which incorporates
IntelGenx’s VersaFilm® technology in a novel formulation, is a
generic version of Belbuca®, an opioid that is used to manage
chronic pain severe enough to require daily, around-the-clock,
long-term treatment with an opioid, when other pain treatments are
inadequate. Approved by the FDA in 2015, Belbuca® is applied to the
oral or buccal mucosa every 12 hours and comes in seven strengths
ranging from 0.075 mg to 0.9 mg.
About Xiromed
Xiromed LLC, located in Florham Park, NJ, is the
U.S. generic division of Insud Pharma, S.L., a global
pharmaceutical group headquartered in Madrid, Spain. Xiromed is
focused on developing and commercializing high quality generic
pharmaceutical products for the US market. In addition to its
commercial portfolio of generics available in the U.S., Xiromed has
a robust development portfolio of generic pharmaceutical products
in various stages of development, including injectable, inhalation
and complex generic products. Learn more at
http://www.xiromed.com/usa.
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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