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The Japan Patent Office (JPO) has issued a Decision to Grant a Patent covering RHB-104 with a 2029 expiry date
RedHill has initiated a long-term population pharmacokineticstudy with RHB-104 for Crohn's disease, designed to satisfy regulatory requirements for future potential marketing applications
The planned number of clinical sites in the ongoing Phase III RHB-104 MAP US study has been increased to up to 90 sites in the U.S., Canada and Israel, with 44 sites already enrolling patients following regulatory approvals in all three countries
RedHill is preparing a second Phase III study with RHB-104 for Crohn's disease in Europe (the MAP Europe study), planned to commence during the second half of the year
RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties
TEL-AVIV, Israel, June 5, 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, including cancer, today reported that the Japan Patent Office (JPO) has issued a Decision to Grant a Patent for a new patent covering RHB-104 in Japan. The patent is expected to be issued during 2014 and will have a 2029 expiry date. RHB-104 is a proprietary antibiotic combination oral capsule formulation for the treatment of Crohn's disease, currently undergoing a Phase III study in the U.S., Canada and Israel (the MAP US study).
RedHill further noted that it has initiated a long-term population pharmacokinetic (Pop PK) study as part of the ongoing RHB-104 Phase III MAP US study. The Pop PK study, together with other supportive studies, including a recently completed food effect study, a drug-drug interaction (DDI) study currently being reviewed and additional clinical and other studies, are designed to satisfy various regulatory requirements for future potential marketing applications of RHB-104.