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June 5, 2014
08:08 EDTRDHLRedHill Biopharma announces new RBH-104 patent in Japan
RedHill Biopharma reported that the Japan Patent Office 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. RedHill further noted that it has initiated a long-term population pharmacokinetic 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 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. In addition to existing FDA clearance in the U.S., RedHill has received regulatory clearance to commence the Phase III MAP US study in Canadian and Israeli sites, and the first clinical sites in both countries have already initiated patient enrollment. As a result, there are currently 44 clinical sites in the U.S., Canada and Israel actively enrolling patients for the RHB-104 Phase III MAP US study. RedHill has increased the total number of planned clinical sites to up to approximately 90 sites in the U.S., Canada and Israel, and is planning additional clinical sites in other countries. RedHill is planning to commence a second Phase III study with RHB-104 for Crohn's disease in Europe following successful Scientific Advice Meetings with the UK and Swedish pharmaceutical regulatory agencies and discussions with key opinion leaders in Europe. The company is currently in the process of selecting a contract research organization for the MAP Europe study. Subject to receiving all the required regulatory approvals and other preparations, the MAP Europe study is planned to commence during the second half of this year.
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January 29, 2015
07:19 EDTRDHLRedHill provides update on RHB-104 Phase III program following FDA meeting
RedHill Biopharma provided an update on the progress with the ongoing RHB-104 Phase III development program for the treatment of Crohn's disease. The company, together with Quest Diagnostics, recently concluded a pre-submission meeting with the FDA regarding the development path of a commercial companion diagnostic test for the detection of Mycobacterium avium subspecies paratuberculosis, or MAP, in Crohn's disease patients. Following the constructive FDA meeting, RedHill intends to initiate a study of approximately 40 Crohn's disease patients to assess the clinical utility of the companion diagnostic test during Q2 or Q3. RedHill is collaborating with Quest Diagnostics for the development of the potential companion diagnostic test, which is an extension of RedHill's development program for the Company's Crohn's disease drug, RHB-104, currently undergoing a first Phase III study. RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, antimycobacterial and anti-inflammatory properties. The development of RHB-104 and the MAP companion diagnostic test is based on increasing evidence supporting the hypothesis that Crohn's disease is caused by MAP infection in susceptible patients. RedHill previously announced that it acquired the rights to patented technologies from the University of Minnesota and the University of Central Florida to support the development of this diagnostic test. There is currently no validated, FDA-approved, commercially available method of detecting the presence or absence of MAP in patients suffering from Crohn's disease and other diseases. RedHill further announced that a protocol amendment has been filed with the FDA to the approved IND in relation to the ongoing Phase III MAP US study with RHB-104 for the treatment of Crohn's disease. As part of the amendment, the number of subjects planned to be enrolled in the study has been increased from 240 to 270 in order to account for potential drop-outs from the study. Additionally, the amendment allows for the inclusion of Crohn's disease patients with moderate to severe disease despite current treatment with anti-Tumor Necrosis Factor therapies infliximab and adalimumab. The inclusion of these concomitant medications significantly increases the number of Crohn's disease patients potentially eligible to enroll in the ongoing Phase III MAP US study. With 66 clinical sites actively enrolling patients, RedHill also plans to increase the number of clinical sites in the Phase III MAP US study, currently ongoing in the U.S., Canada and Israel, from 100 to 120, including new sites in Australia, New Zealand and Europe.

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