IntelGenx Facility Undergoes U.S. FDA Pre-Approval Inspection Related to RIZAPORT® NDA
SAINT LAURENT, Quebec, Jan. 30, 2019 (GLOBE NEWSWIRE) — IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (“IntelGenx”), a leading oral drug delivery company, today announced that the U.S. Food and Drug Administration (“FDA”) has performed a Pre-Approval Inspection (“PAI”) of the company’s Health Canada-certified cGMP manufacturing facility in Montreal. The PAI is related to the IntelGenx New Drug Application (“NDA”) for RIZAPORT®, a VersaFilm™ oral soluble film for the treatment of acute migraines. At the conclusion of the PAI on January 25, the FDA issued a Form 483 with five inspectional observations.
“We appreciate the thoroughness of the FDA’s review of our facility, and we are confident that we will be able to address the FDA’s observations within the 15-day response timeframe,” said Dr. Horst G. Zerbe, President and CEO of IntelGenx. “As we continue to advance through the NDA process, IntelGenx is excited to have completed another important milestone toward U.S. approval.”
The FDA has assigned a Prescription Drug User Fee Act goal date of April 1, 2019, for completion of the review of the resubmitted NDA for RIZAPORT®. IntelGenx does not expect the inspectional observations to impact the timeline for the FDA’s decision on the approval of RIZAPORT®.
In December 2018, IntelGenx entered into a definitive licensing, development and supply agreement granting Gensco® Pharma the exclusive right to commercialize the IntelGenx RIZAPORT® product in the United States.
RIZAPORT® is a patent protected proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.’s Maxalt®.
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. 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, which was established for the VersaFilm™ technology platform, offers by supporting lab-scale to pilot- and commercial-scale production. More information about the company can be found at www.intelgenx.com.
Forward Looking 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.
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.
CONTACT: For more information please contact: Stephen Kilmer Investor Relations (514) 331-7440 ext 232 email@example.com Or Andre Godin, CPA, CA Executive Vice-President and CFO IntelGenx Corp. (514) 331-7440 ext 203 firstname.lastname@example.org