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SAINT LAURENT, Quebec, Sept. 24, 2018 (GLOBE NEWSWIRE) — IntelGenx Corp. (IGX.V) (IGXT) (the “Company” or “IntelGenx”) today appear acknowledged after-effects from a bioequivalence abstraction for RIZAPORT®, its proprietary anti-migraine VersaFilm™ product. The abstraction after-effects accustomed RIZAORT® is bioequivalent to the U.S. reference, Maxalt®-MTL, and the European reference, Maxalt®-Lingua. 

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RIZAPORT® is a proprietary articulate thin-film conception of rizatriptan for the ysis of astute migraines. RIZAPORT® offers an avant-garde and potentially advantageous ameliorative another for abounding cephalalgia patients, primarily patients who ache from dysphagia or migraine-related nausea, due to its acceptable dosing, accomplished assimilation due to the abridgement of charge for water, and aloof flavor.

The bioequivalence abstraction was a single-dose, randomized, open-label, three-way crossover, pivotal, allusive bioavailability abstraction of RIZAPORT® 10 mg, Maxalt®-MLT 10 mg orally aition tablets and Maxalt®-Lingua 10 mg oro-dispersible tablets in 30 advantageous volunteers. The abstraction was conducted beneath the administering of Biopharma Casework in Toronto, ON. 

The bioequivalence abstraction is accepted to abutment the acquiescence of the added advice accompanying to the alteration of accomplishment to IntelGenx’ GMP adjustable armpit appropriate by the U.S. Food and Biologic Administering (“FDA”) to acquiesce for a abounding ysis of the Company’s 505(b)(2) New Biologic Appliance (“NDA”) resubmission for RIZAPORT®. The abstraction will additionally be acclimated to abutment applications to alteration the accomplishment of RIZAPORT® from the European arrangement architect listed in the antecedent appliance to IntelGenx’ site. Additionally, it will be acclimated to abutment applications in added European countries.

“This acknowledged bioequivalence abstraction helps pave the way for RIZAPORT®, already approved, to be the aboriginal commercialized VersaFilm™product to be bogus at our new advanced facility,” said Dr. Horst G. Zerbe, President and CEO of IntelGenx.

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“A few years ago, we fabricated the cardinal accommodation to transform IntelGenx from a development aggregation that relied on ability and authorization revenues from a bound artefact portfolio into a full-service, all-around baton of avant-garde biologic articulate blur development and manufacturing,” connected Dr. Zerbe. “While that accommodation briefly impacted on the Company’s advantage due to the charge to accomplish cogent new investments in bulb and people, we durably believed that we had an befalling to body a abundant stronger business – one able to drive cogent and acceptable advance over both the mid- and long-terms. In abounding ways, advancing approvals to accomplish RIZAPORT® at IntelGenx’ armpit will serve to advice validate that choice. We attending advanced to afterlight all of our stakeholders as we progress.” 

About RIZAPORT® (RHB-103):

RIZAPORT® is a proprietary articulate attenuate blur conception of rizatriptan benzoate, a 5-HT1 receptor agonist and the alive biologic in Merck & Co.’s Maxalt®. RIZAPORT® 5 mg and 10 mg were accustomed for business in Germany in October 2015 and in Luxembourg in April 2017 beneath the European Decentralized Procedure. A New Biologic Appliance for RIZAPORT® was resubmitted to the FDA in October 2017.

Rizatriptan is advised to be one of the best able articulate triptans, a chic of molecules that constricts claret argosy in the academician to abate abscess and added cephalalgia symptoms. RIZAPORT® is based on IntelGenx’ proprietary VersaFilm™ technology. It dissolves rapidly and releases its alive additive in the mouth, arch to able assimilation of the biologic through the gastrointestinal tract. The administering adjustment of the RIZAPORT® articulate acrid film, which does not crave the accommodating to absorb a us or absorb water, forth with its aloof flavor, presents a potentially adorable ameliorative another for cephalalgia patients, accurately for patients who ache from migraine-related nausea, estimated to be about 80% of the absolute cephalalgia accommodating citizenry and patients adversity from dysphagia (difficulty swallowing)1.

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Reference:

1 Lipton RB, Buse DC, Saiers J, Fanning KM, Serrano D, Reed ML. (2013) Frequency and accountability of headache-related nausea: after-effects from the American Cephalalgia Prevalence and Prevention (AMPP) study, Headache. 2013 Jan;53(1):93-103.

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About IntelGenx:

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Luxury Client Intake form Template | Template – patient intake form | patient intake form

Established in 2003, IntelGenx is a arch articulate biologic commitment aggregation primarily focused on the development and accomplishment of avant-garde biologic articulate films based on its proprietary VersaFilm™ technology platform.

IntelGenx’ awful accomplished aggregation provides absolute pharmaceuticals casework to biologic partners, including R&D, ytic adjustment development, ytic monitoring, IP and authoritative services. IntelGenx’ advanced accomplishment facility, accustomed for the VersaFilm™ technology platform, supports lab-scale to pilot and commercial-scale production, alms abounding account capabilities to its clients. More advice about the aggregation can be begin at www.intelgenx.com.

Forward Attractive Statements:

This certificate may accommodate advanced advice about IntelGenx’ operating after-effects and business affairs that absorb abundant risks and uncertainties. Statements that are not absolutely absolute are advanced statements aural the acceptation of Section 21E of the Balance Exchange Act of 1934, as amended, and Section 27A of the Balance Act of 1933, as amended. These statements include, but are not bound to, statements about IntelGenx’ plans, objectives, expectations, strategies, intentions or added characterizations of approaching contest or affairs and are about articular by the words “may,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “could,” “would,” and agnate expressions. All advanced attractive statements are especially able in their absoluteness by this cautionary statement. Because these advanced statements are accountable to a cardinal of risks and uncertainties, IntelGenx’ absolute after-effects could alter materially from those bidding or adumbrated by these advanced statements. Factors that could account or accord to such differences include, but are not bound to, those discussed beneath the branch “Risk Factors” in IntelGenx’ anniversary address on Form 10-K, filed with the United States Balance and Exchange Commission and accessible at www.sec.gov, and additionally filed with Canadian balance authoritative authorities at www.sedar.com. IntelGenx assumes no obligation to amend any such advanced statements.

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Each of the TSX Venture Exchange and OTCQX has neither accustomed nor banned the capacity of this columnist release. Neither TSX Venture Exchange nor its Regulation Casework Provider (as that appellation is authentic in the behavior of the TSX Venture Exchange) accepts albatross for the capability or accurateness of this release.

Source: IntelGenx Technologies Corp.

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