IntelGenx Announces FDA Approval of RIZAFILM® for the Treatment of Acute Migraine

Rhea-AI Summary

IntelGenx Corp. announced FDA approval for its migraine treatment, RIZAFILM®, which will be the first oral thin film available in the U.S. for acute migraines. The product, a proprietary formulation of rizatriptan benzoate, addresses a significant market need, as approximately 39 million Americans suffer from migraines. The global migraine medication market is projected to grow from $3 billion in 2021 to nearly $11 billion by 2030, with a compound annual growth rate of 15.6%. IntelGenx has partnered with Gensco® Pharma for the commercialization of RIZAFILM®, benefiting from royalty payments based on net profits and milestone payments. Following a successful FDA inspection of its manufacturing facility, IntelGenx is well-positioned to meet market demands for rapid, effective migraine relief.

Positive

• FDA approved RIZAFILM® for acute migraine treatment.
• First oral thin film treatment available in the U.S. market.
• Significant market opportunity projected to grow from $3 billion to $11 billion by 2030.
• Partnership with Gensco® Pharma allows for royalty payments and milestone incentives.

Negative

• None.

Partner Gensco® Pharma preparing to commercially launch RIZAFILM® across the United States as soon as is practicable

SAINT LAURENT, Quebec, April 17, 2023 (GLOBE NEWSWIRE) -- 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 Corporation
² Reports and Data, Migraine Drugs Market, https://www.reportsanddata.com/sample-enquiry-form/2515
³ 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 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 RIZAFILM® approved for?

RIZAFILM® is approved by the FDA for the treatment of acute migraines.

When will RIZAFILM® be launched in the U.S.?

Gensco® Pharma is preparing to commercially launch RIZAFILM® across the U.S. as soon as practicable.

What is the market potential for RIZAFILM®?

The global migraine drugs market is projected to reach nearly $11 billion by 2030.

How does RIZAFILM® benefit migraine patients?

RIZAFILM® offers convenient administration and quick relief, suitable for patients with migraine-related nausea.

What is the significance of the partnership with Gensco® Pharma?

The partnership allows IntelGenx to receive royalty payments based on net profits and milestone achievements.