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IntelGenx Receives USPTO Notice of Allowance for Loxapine Orange Book Eligible Patent

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IntelGenx Corp. (IGXT) announced the granting of a Notice of Allowance for a U.S. patent covering its Loxapine oral film formulations, designed for patients with anxiety and agitation associated with schizophrenia and bipolar 1 disorder. This formulation aims to facilitate quicker administration compared to traditional inhalers, which require physician supervision. CEO Horst G. Zerbe emphasized that this patent solidifies long-term market exclusivity for the Loxapine VersaFilm®, enhancing the company's intellectual property portfolio and addressing unmet medical needs in mental health treatments.

Positive
  • Patent granted for Loxapine film formulations increases market exclusivity.
  • Potential for Loxapine VersaFilm® to improve patient access to treatment.
  • Innovative formulation offers a quick administration alternative to inhalers.
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  • None.

SAINT LAURENT, Quebec, Feb. 21, 2023 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx”), a leader in pharmaceutical films, today announced that the United States Patent and Trademark Office (“USPTO”) has granted a Notice of Allowance for U.S. Patent Application 16/053,383, entitled "Loxapine Film Oral Dosage Form.”

This film formulation patent covers Loxapine oral film formulations designed for use in patients with anxiety and agitation associated with schizophrenia and bipolar 1 disorder, and is intended to protect IntelGenx' Loxapine VersaFilm® product.

The new, soon to be patented, Loxapine oral film technology is designed to provide quick onset and a simple administration process for schizophrenia and bipolar 1 disorder patients. Currently, the marketed loxapine product for agitation treatment in schizophrenia and bipolar mania is an inhaler that can only be administered at certified healthcare settings under supervision of a physician. IntelGenx's Loxapine VersaFilm® is intended as a rescue medication which can be administered by caregivers and, therefore, has the potential to increase availability of the drug to patients.

"The granting of this notice of allowance for a formulation specific orange book eligible patent for our Loxapine oral film validates the innovative work carried out on this project by our talented R&D team," said Horst G. Zerbe, CEO of IntelGenx. "While expanding our overall intellectual property portfolio, this new patent also solidifies the potential long-term market exclusivity of our unique Loxapine VersaFilm® product candidate."

About Loxapine VersaFilm®

Loxapine VersaFilm® is the first innovative oral thin film of loxapine for use in patients with agitation associated with schizophrenia and bipolar 1 disorder. Loxapine VersaFilm® utilizes IntelGenx’s proprietary VersaFilm® technology, allowing for an improved drug product which addresses unmet medical needs in schizophrenia and bipolar 1 disorder.

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 Kilmer
Investor Relations
(647) 872-4849
stephen@kilmerlucas.com

Or

Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com 


FAQ

What is the significance of the Loxapine patent granted to IntelGenx on February 21, 2023?

The patent grants IntelGenx exclusive rights to its Loxapine oral film formulations, potentially increasing market share and protecting its intellectual property.

How does the Loxapine VersaFilm<sup>®</sup> differ from existing treatments?

Unlike current inhaler treatments that require physician supervision, Loxapine VersaFilm® can be administered by caregivers, improving accessibility.

What conditions does the Loxapine oral film target?

The Loxapine oral film targets anxiety and agitation associated with schizophrenia and bipolar 1 disorder.

What is the stock symbol for IntelGenx?

The stock symbol for IntelGenx is IGXT.

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