RedHill Biopharma and IntelGenx Announce First European Marketing Approval of RIZAPORT(TM) (RHB-103) for Migraines

• The German Federal Institute for Drugs and Medical Devices (BfArM) has granted national marketing approval for RIZAPORT^(TM) (RHB-103) for the treatment of acute migraines under the European Decentralized Procedure (DCP)
• RedHill and IntelGenx continue their close cooperation in order to obtain approvals in additional European countries and in the U.S., where a New Drug Application (NDA) was submitted and a Complete Response Letter was received
• RedHill and IntelGenx continue to advance their activities to secure commercialization partners in Europe, the U.S. and additional territories
• RIZAPORT^(TM), an oral thin film formulation of rizatriptan for acute migraines, offers an innovative therapeutic alternative for many migraine patients, primarily patients who suffer from dysphagia or migraine-related nausea

TEL-AVIV, Israel, Nov. 9, 2015 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including cancer, today announced, together with IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx"), a Canadian drug delivery company focused on oral drug delivery, that the Federal Institute for Drugs and Medical Devices of Germany (BfArM) has granted marketing authorization of RIZAPORT^(TM) (RHB-103) 5mg and 10mg, an oral thin film formulation of rizatriptan benzoate for the treatment of acute migraines.

Over 50 million people in Europe are estimated to be affected by migraines. Approximately 2 million Europeans are prone to migraine attacks every day¹. The worldwide migraine market is expected to exceed $2 billion in sales in 2016.

The national approval of RIZAPORT^(TM) in Germany was granted under the European Decentralized Procedure (DCP), in which Germany served as the Reference Member State. This authorization is the first national marketing approval of RIZAPORT^(TM). Marketing authorization in Luxemburg, the Concerned Member State, is expected to follow. RedHill and IntelGenx intend to continue to work together to obtain national phase approvals in other European DCP territories.

Dr. Reza Fathi, Ph.D., RedHill's Senior VP R&D, said: "We are very pleased to receive German marketing authorization for RIZAPORT^(TM). This is the first drug in RedHill's advanced pipeline to gain marketing approval, a significant milestone for the Company that reflects our team's commitment and execution capabilities, as well as the successful cooperation with IntelGenx."