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RedHill Biopharma Announces Positive European Scientific Advice Meeting Regarding RHB-102 And Plans To Submit A European Marketing Application

  • The Company concluded a positive scientific advice meeting with the UK MHRA regarding RHB-102 and plans to submit, during the second half of the year, a European marketing application for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting in cancer patients
  • RHB-102 is a proprietary, once-daily, oral pill formulation of the anti-emetic oncology support drug ondansetron
  • The Company commenced a comparative bioavailability study with RHB-102 to support its planned European marketing application, with study results expected by July 2014
  • In addition to the currently pursued indications, the MHRA provided guidance regarding a new undisclosed indication which may significantly expand RHB-102's potential market; A Phase III study for this indication is planned in the U.S. for later this year

TEL-AVIV, Israel, April 7, 2014 (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 drugs for the treatment of inflammatory and gastrointestinal diseases and related conditions, today announced that it had concluded a positive European scientific advice meeting with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) regarding RHB-102, a proprietary, extended-release (once-daily) oral pill formulation of the anti-emetic oncology support drug ondansetron for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting ("CINV" and "RINV" respectively).

In light of the positive feedback from the UK MHRA, RedHill intends to submit, during the second half of the year, a Marketing Authorization Application (MAA) in Europe with the UK as the reference EU member state for the European Mutual Recognition Procedure (MRP).

To support the planned MAA submission, RedHill has commenced a comparative bioavailability study comparing RHB-102 to the European reference drug. The two-arm crossover comparative bioavailability study includes 20 healthy volunteers and is intended to explore the relative bioavailability between RHB-102 and GlaxoSmithKline's European reference drug. The secondary objective of the study is to further assess the safety and tolerability of RHB-102.

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