RedHill Biopharma: BfArM Validates European MAA Submitted For RIZAPORT

(RTTNews) - RedHill Biopharma Ltd. (RDHL) announced, together with IntelGenx Corp. (IGX.V, IGXT.PK), that the German Federal Institute for Drugs and Medical Devices (BfArM) validated the Marketing Authorization Application or 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 population.

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, the company said.