INDICATED FOR MIGRAINE

Rizaport® is the first rizatriptan oral disintegrating film for the treatment of migraine to achieve E.U. marketing approval. Rizaport® is a new product opportunity co-developed in partnership with RedHill Biopharma and formulated using VersaFilm™, IntelGenx proprietary oral film technology.

Rizatriptan is a selective 5-HT1B/1D receptor agonist indicated for the treatment of migraine. Compared to other triptan-based medications, rizatriptan demonstrates the highest efficacy and exhibits the shortest Tmax providing a quick onset of action for migraine sufferers.

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. Rizatriptan is also indicated for the treatment of migraine attacks in children and elderly who could both benefit from the ease of administration of the Rizaport® film formulation.

Rizaport® demonstrated bioequivalence in a successful pivotal clinical trial compared to the reference listed drug Maxalt-MLT® (Merck & Co.). IntelGenx submitted a 505(b)(2) New Drug Application for regulatory approval to the U.S. Food and Drug Administration in Q1 2013. In addition, in November 2015, the German Federal Institute for Drugs and Medical Devices (BfArM) has granted national marketing approval for Rizaport® for the treatment of acute migraines under the European Decentralized Procedure (DCP).

According to Merck’s annual report, sales of Maxalt® were $638 million in 2012. Global migraine sales are expected to grow to $8.7 billion by 2026, at a Compound Annual Growth Rate (CAGR) of 10.3%2. Commercialization agreements for Rizaport® were signed with Grupo JUSTE S.A.Q.F (now Exeltis Healthcare, S.L.) for Spain and Pharmatronic Co. for South Korea.

IntelGenx and RedHill Biopharma are currently looking for a partnership or alliance opportunity to commercialize Rizaport®.

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.
2 GlobalData, Report. 2017 Aug

Rizaport® is a registered trademark of RedHill Biopharma Ltd.
Maxalt-MLT® is a registered trademark of Merck & Co., Inc.