Dr. Horst Zerbe reports
INTELGENX TO REGAIN EXCLUSIVE WORLDWIDE RIGHTS TO DEVELOP AND COMMERCIALIZE RIZAPORT
IntelGenx Technologies Corp. has received notice that RedHill Biopharma Ltd. intends to terminate its agreement with the company for the co-development and commercialization of Rizaport. The termination notice follows receipt of a communication by the United States Food and Drug Administration indicating that, based on an initial review of the 505(b)(2) New Drug Application resubmission for Rizaport 10-millgram, the agency will require additional information before the NDA resubmission is deemed complete and permitted a full review.
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 flavour.
Following a first Rizaport NDA submission to the FDA in March, 2013, IntelGenx and RedHill received a complete response letter from the agency. The questions raised by the FDA, which triggered the current resubmission, primarily related to third party chemistry, manufacturing and controls, and the packaging and labelling of the product. The FDA raised no questions or deficiencies relating to Rizaport's safety and bioequivalence data and did not require additional clinical trials.
"We are disappointed by the delay, but remain committed to working with the FDA to achieve our goal of bringing this product to the U.S. market," commented Dr. Horst Zerbe, president and chief executive officer of IntelGenx. "To that end, we are planning to meet with the agency as soon as practicable to clarify its additional information request."
Dr. Zerbe continued: "We are grateful for RedHill's support over the past few years and believe that the data generated through this partnership validate the potential for Rizaport as a new therapeutic option for the benefit of patients suffering from migraines. IntelGenx will continue its dialogue with prospective new commercial partners for Rizaport in the U.S., Europe and other territories, and we do not expect this change to materially affect those discussions. We also intend on fully honouring the existing licensing agreements with Grupo JUSTE SAQF and Pharmatronic Co. to commercialize Rizaport in Spain and South Korea, respectively."
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 U.S. FDA in October, 2017.
Rizatriptan is considered to be one of the most effective oral triptans, a class of molecules that constrict 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 flavour, presents a potentially attractive therapeutic alternative for migraine patients, specifically for patients who suffer from migraine-related nausea, estimated to be approximately 80 per cent of the total migraine patient population and patients suffering from dysphagia (difficulty swallowing) (1).
Lipton, D.C. Buse, J. Saiers, K.M. Fanning, D. Serrano, M.L. Reed. (2013) Frequency and burden of headache-related nausea: results from the American Migraine Prevalence and Prevention (AMPP) study, Headache. January, 2013 ;53(1):93-103.
About IntelGenx Technologies Corp.
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 research and development, analytical method development, clinical monitoring, IP (intellectual property), 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.
We seek Safe Harbor.
© 2022 Canjex Publishing Ltd. All rights reserved.