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The Company held a Scientific Advice meeting regarding RHB-101 with the Danish Health and Medicines Authority (DKMA)
Following the positive results of the meeting, the Company intends to submit a Marketing Authorization Application (MAA) to market RHB-101 in Europe, with Denmark as the reference member state for the European Mutual Recognition Procedure (MRP)
The Company is also continuing to explore the parallel regulatory path for marketing approval of RHB-101 in the U.S.
RHB-101 is a proprietary, controlled release, once-daily formulation of carvedilol, for the treatment of hypertension
TEL-AVIV, Israel, March 19, 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, patent-protected, new formulations and combinations of existing drugs, reported that it recently concluded a positive European Scientific Advice meeting with the Danish Health and Medicines Authority (DKMA) regarding its cardio drug RHB-101, a controlled release, proprietary, once-daily formulation of carvedilol, for the treatment of hypertension.
RedHill intends to submit a Marketing Authorization Application (MAA) in Europe with Denmark as the reference member state for the European Mutual Recognition Procedure (MRP). Based on the positive response in the official minutes of the meeting with the DKMA, RedHill believes that no further clinical studies will be required prior to submission of the MAA. The Company plans to focus on certain chemistry, manufacturing and control modules, the completion of which is expected to allow the submission of an MAA.
The Scientific Advice Meeting and the intended MAA submission follow the prior successful completion of four pharmacokinetic (PK) clinical trials comparing RHB-101 to Eucardic
®, the branded immediate release carvedilol marketed by Roche in Europe (the equivalent U.S. market brand name is Coreg
®, marketed by GSK).
In parallel, RedHill is continuing to explore the regulatory path for marketing approval of RHB-101 in the U.S.