RedHill Biopharma Ltd. (RedHill), a specialty biopharmaceutical company, together with IntelGenx Corp. (IntelGenx), a leading oral drug delivery company, announced that the Ministry of Health of Luxembourg has granted national marketing authorization for Rizaport (5 mg and 10 mg), a proprietary oral thin film formulation of rizatriptan benzoate for the treatment of acute migraines.

The national marketing authorization was granted in Luxembourg on the basis of the European Decentralized Procedure (DCP), in which Luxembourg served as the Concerned Member State. The approval in Luxembourg marks the completion of the current marketing approval process for Rizaport under the European DCP. This process requires marketing approval in at least two European states, a Reference Member State and a Concerned Member State. Rizaport (5 mg and 10 mg) was previously approved for marketing in Germany, which served as the Reference Member State. Under the European DCP, marketing authorization approval of Rizaport in additional European countries is subject to a separate procedure to obtain additional national marketing authorizations in each country.

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 pleasant flavor.

A first commercialization agreement for Rizaport was signed with Grupo JUSTE S.A.Q.F (now Exeltis Healthcare, S.L.) for Spain and, subsequently, a national Marketing Authorization Application (MAA) for Rizaport was submitted by Grupo JUSTE.

A second commercialization agreement for Rizaport was recently signed with Pharmatronic Co. for South Korea.

RedHill and IntelGenx expect to re-submit the Rizaport 505(b)(2) New Drug Application (NDA) to the US Food and Drug Administration (FDA) in the third quarter of 2017. The companies are continuing discussions with additional potential commercialization partners for Rizaport in the United States., Europe and other territories.

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 also filed with the US FDA in 2013 and a Complete Response Letter was received in 2014. RedHill has entered into licensing agreements to commercialize Rizaport in Spain (with Grupo JUSTE S.A.Q.F) and in South Korea (with Pharmatronic Co.). 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 thin film, which does not require the patient to swallow a pill or consume water, along with its pleasant 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).

RedHill Biopharma Ltd. is a specialty biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer.

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.