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The Company and its co-development partner, IntelGenx Corp., held a Scientific Advice meeting with the German pharmaceuticals regulation authority (BfArM) and plan to submit a Marketing Authorization Application (MAA) to market RHB-103 in Europe during the first half of 2014
RHB-103 is a proprietary oral thin film formulation of rizatriptan, the active drug in Merck & Co.'s Maxalt MLT®
A U.S. New Drug Application (NDA) for RHB-103 is currently being reviewed by the FDA with a PDUFA goal date of February 3, 2014
TEL-AVIV, Israel, Nov. 18, 2013 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs, today reported that the Company and its co-development partner, IntelGenx Corp. ("IntelGenx"), have recently concluded a positive European Scientific Advice meeting with the German Federal Institute for Drugs and Medical Devices (BfArM) regarding RHB-103, a proprietary, oral thin film formulation of rizatriptan for the treatment of acute migraine.
The Scientific Advice meeting with the BfArM provided sufficient clarity with regard to the regulatory path. Consequently, RedHill plans to conduct a small bioavailability study comparing RHB-103 to the European reference product.
RedHill previously conducted a successful bioequivalence trial which demonstrated the required U.S. Food and Drug Administration (FDA) criteria for therapeutic bioequivalence between the soluble oral thin film of RHB-103 and Merck & Co.'s Maxalt MLT
®, the reference drug available in the U.S. In March 2013, following the successful bioequivalence study, RedHill submitted to the FDA a New Drug Application (NDA) seeking marketing approval of RHB-103. The FDA is currently conducting a substantive review of the NDA and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 3, 2014.
Following the positive meeting with the BfArM, RedHill plans to complete the bioavailability study and submit a Marketing Authorization Application (MAA) for marketing approval of RHB-103 in Europe, with Germany as the reference member state under the European Mutual Recognition Procedure (MRP), during the first half of 2014.