RedHill Biopharma And IntelGenx Announce Acceptance For Review Of European Marketing Application For RIZAPORT For Migraines

RedHill Biopharma Ltd.

("RedHill"), an Israeli biopharmaceutical company primarily focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced, together with IntelGenx Corp.

("IntelGenx"), a Canadian drug delivery company focused on oral drug delivery, that the German Federal Institute for Drugs and Medical Devices (BfArM) validated the Marketing Authorization Application (MAA) for RIZAPORT™, an oral thin film formulation of rizatriptan for acute migraines, and has initiated the formal review process of the application on November 25, 2014. BfArM's potential feedback regarding the MAA is expected during the second half of 2015. RIZAPORT™ oral thin film does not require the patient to swallow a pill or consume water and presents a potentially attractive therapeutic alternative for many migraine patients, including those who suffer from migraine-related nausea, estimated to be approximately 80% of the total migraine patient population1. The MAA was submitted under the European Mutual Recognition Procedure (MRP) with Germany as the reference member state and Luxemburg as the Concerned Member State. The submission is supported by several studies and follows a positive scientific advice meeting with the BfArM. RedHill and IntelGenx submitted a New Drug Application (NDA) to the FDA in March 2013 seeking marketing approval of RIZAPORT™ in the U.S. Following a complete response letter (CRL) received from the FDA in February 2014, which raised questions primarily related to CMC, RedHill and IntelGenx reported that they believe that FDA approval of the RIZAPORT™ NDA is subject to the satisfactory resolution of the remaining CMC questions, as well as securing a compliant source of the raw material. Accordingly, the companies continue to work with the FDA in order to address and resolve all remaining CMC questions and to secure a compliant source of the raw material.