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The Spanish Agency of Medicines and Medical Devices Grants Marketing Authorization of RIZAPORT®
SAINT LAURENT, Quebec, Oct. 31, 2018 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V: IGX) (OTCQX: IGXT) (the “Company” or “IntelGenx”) is pleased to announced that its commercialization partner for RIZAPORT® (10mg) in Spain, Groupo Juste, which is now part of Exceltis Healthcare, has received national marketing authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS) for the product.
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.
Following the approval of the manufacturing site transfer of RIZAPORT® from the European contract manufacturer listed in the initial manufacturing site transfer application to IntelGenx’s GMP compliant facility in Montreal, Canada, this marketing authorization will enable IntelGenx’s marketing partner, Exceltis Healthcare, to commercialize the product in Spain. The Company believes that recently reported results from a successful study, demonstrating that RIZAPORT® is bioequivalent to the European reference, Maxalt®-Lingua, will further support the site transfer application in Spain.
“This marketing authorization in Spain marks the achievement of a major milestone for our company, materially advancing RIZAPORT® toward becoming the first-ever commercialized VersaFilm™ product to be manufactured at our new state-of-the-art facility,” said Dr. Horst G. Zerbe, President and CEO of IntelGenx.
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®. A New Drug Application for RIZAPORT® was resubmitted to the U.S. Food and Drug Administration in September 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’s 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’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, 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:
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Source: IntelGenx Technologies Corp.
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