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IntelGenx Announces Successful Results from RIZAPORT® Bioequivalence Study
SAINT LAURENT, Quebec, Sept. 24, 2018 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V: IGX) (OTCQX: IGXT) (the “Company” or “IntelGenx”) today announced successful results from a bioequivalence study for RIZAPORT®, its proprietary anti-migraine VersaFilm™ product. The study results demonstrated RIZAORT® is bioequivalent to the U.S. reference, Maxalt®-MTL, and the European reference, Maxalt®-Lingua.
RIZAPORT® is a proprietary oral thin-film formulation of rizatriptan for the treatment of acute migraines. RIZAPORT® offers an innovative and potentially advantageous therapeutic alternative for many migraine patients, primarily patients who suffer from dysphagia or migraine-related nausea, due to its convenient dosing, facile intake due to the lack of need for water, and neutral flavor.
The bioequivalence study was a single-dose, randomized, open-label, three-way crossover, pivotal, comparative bioavailability study of RIZAPORT® 10 mg, Maxalt®-MLT 10 mg orally disintegrating tablets and Maxalt®-Lingua 10 mg oro-dispersible tablets in 30 healthy volunteers. The study was conducted under the direction of Biopharma Services in Toronto, ON.
The bioequivalence study is expected to support the submission of the additional information related to the transfer of manufacturing to IntelGenx’ GMP compliant site required by the U.S. Food and Drug Administration ("FDA") to allow for a full review of the Company’s 505(b)(2) New Drug Application ("NDA") resubmission for RIZAPORT®. The study will also be used to support applications to transfer the manufacturing of RIZAPORT® from the European contract manufacturer listed in the initial application to IntelGenx’ site. Additionally, it will be used to support applications in additional European countries.
“This successful bioequivalence study helps pave the way for RIZAPORT®, once approved, to be the first commercialized VersaFilm™product to be manufactured at our new state-of-the-art facility,” said Dr. Horst G. Zerbe, President and CEO of IntelGenx.
“A few years ago, we made the strategic decision to transform IntelGenx from a development company that relied on royalty and license revenues from a limited product portfolio into a full-service, global leader of innovative pharmaceutical oral film development and manufacturing," continued Dr. Zerbe. "While that decision temporarily impacted on the Company’s profitability due to the need to make significant new investments in plant and people, we firmly believed that we had an opportunity to build a much stronger business – one able to drive significant and sustainable growth over both the mid- and long-terms. In many ways, anticipated approvals to manufacture RIZAPORT® at IntelGenx’ site will serve to help validate that choice. We look forward to updating all of our stakeholders as we progress.”
About RIZAPORT® (RHB-103):
RIZAPORT® is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt®. RIZAPORT® 5 mg and 10 mg were approved for marketing in Germany in October 2015 and in Luxembourg in April 2017 under the European Decentralized Procedure. A New Drug Application for RIZAPORT® was resubmitted to the FDA in October 2017.
Rizatriptan is considered to be one of the most effective oral triptans, a class of molecules that constricts blood vessels in the brain to relieve swelling and other migraine symptoms. RIZAPORT® is based on IntelGenx' proprietary VersaFilm™ technology. It dissolves rapidly and releases its active ingredient in the mouth, leading to efficient absorption of the drug through the gastrointestinal tract. The administration method of the RIZAPORT® oral soluble film, which does not require the patient to swallow a pill or consume water, along with its neutral flavor, presents a potentially attractive therapeutic alternative for migraine patients, specifically for patients who suffer from migraine-related nausea, estimated to be approximately 80% of the total migraine patient population and patients suffering from dysphagia (difficulty swallowing)1.
1 Lipton RB, Buse DC, Saiers J, Fanning KM, Serrano D, Reed ML. (2013) Frequency and burden of headache-related nausea: results from the American Migraine Prevalence and Prevention (AMPP) study, Headache. 2013 Jan;53(1):93-103.
Established in 2003, IntelGenx is a leading oral drug delivery company primarily focused on the development and manufacturing of innovative pharmaceutical oral films based on its proprietary VersaFilm™ technology platform.
IntelGenx' highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx' state-of-the-art manufacturing facility, established for the VersaFilm™ technology platform, supports lab-scale to pilot and commercial-scale production, offering full service capabilities to its clients. More information about the company can be found at www.intelgenx.com.
Forward Looking Statements:
This document may contain forward-looking information about IntelGenx' 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' 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' 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' 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.
Each of the TSX Venture Exchange and OTCQX has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Source: IntelGenx Technologies Corp.
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