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February 4, 2014
08:13 EDTIGXT, RDHLRedHill Biopharma, IntelGenx receive complete response letter from FDA
RedHill Biopharma (RDHL) together with IntelGenx (IGXT) announced that they received a Complete Response Letter, or CRL from the FDA regarding the New Drug Application for RHB-103 for the treatment of acute migraines. RHB-103 is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt. A CRL is issued by the FDA's Center for Drug Evaluation and Research to inform companies that certain questions and deficiencies remain that preclude the approval of the application in its present form. The questions raised by the FDA in the CRL regarding the NDA for RHB-103 primarily relate to third party Chemistry, Manufacturing and Controls and to the packaging and labeling of the product. No questions or deficiencies were raised relating to the product's safety and the FDA's CRL does not require additional clinical studies. While continuing to review the FDA's CRL, RedHill and IntelGenx believe that they can supply the requested information based on available data. IntelGenx and RedHill further believe that the majority of issues raised by the FDA were recently addressed in an amendment submitted by the companies to the FDA that has yet to be reviewed. The companies will work with the FDA to address the remaining questions in the CRL and plan to submit the requested information within a few weeks. RedHill and IntelGenx have been in active discussions with potential partners for the commercialization of RHB-103 and expect to advance these discussions rapidly following FDA's CRL which provides increased regulatory clarity, indicates that no further clinical trials are required, and raises no issues regarding RHB-103's safety.
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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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