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May 22, 2014
08:20 EDTRDHLRedHill Biopharma announces FDA clearance for Phase III study with RHB-102
RedHill Biopharma announced that the FDA has allowed the initiation of the company's planned Phase III clinical study for the treatment of a new, undisclosed indication with RHB-102, an extended release oral pill formulation of the antiemetic drug ondansetron. RedHill plans to begin enrolling patients for the Phase III study during Q3. The double-blind placebo-controlled Phase III study is planned to be conducted in eight clinical sites in the U.S. and will include 320 subjects. Based on prior discussions with the FDA and the UK Medicines and Healthcare Products Regulatory Agency, or MHRA, the study is intended to support potential future submissions of marketing applications for a new undisclosed indication in both the U.S. and Europe. RedHill estimates that, if the Phase III clinical study is successful and the marketing applications are filed and approved by the FDA and the MHRA, the new indication would significantly expand the potential market for RHB-102. In parallel to pursuing the new undisclosed indication, RedHill is pursuing marketing approval of RHB-102 for the indications of chemotherapy and radiotherapy-induced nausea and vomiting in Europe and the U.S.
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December 18, 2014
06:18 EDTRDHLRedHill Biopharma acquires techonology from University of Minnesota
RedHill Biopharma (RDHL) has entered into a license agreement with the University of Minnesota to acquire the rights to a patented technology to support the development of a commercial diagnostic test for detection of Mycobacterium avium subspecies paratuberculosis bacterium. RedHill's Crohn's disease program RHB-104, currently undergoing a first Phase III study, is based on evidence that Crohn's disease is caused by MAP infection in susceptible patients. As part of development for RHB-104, RedHill is developing, in collaboration with Quest Diagnostics (DGX), a diagnostic test to aid in detecting the presence of MAP in whole blood. RedHill will pay the University of Minnesota a one-time upfront payment and an additional potential milestone payment for the licensed technology. A pre-submission meeting with the FDA to discuss the development path for the diagnostic test is scheduled for January 2015.
December 17, 2014
06:14 EDTRDHLRedHill Biopharma enrolls first patients in Phase III study of RHB-102
Red Hill announced that the randomized, double-blind, placebo-controlled Phase III study with RHB-102 for acute gastroenteritis and gastritis is underway in the U.S., with a planned enrollment of 320 patients. Top-line results from the Phase III GUARD study are expected during 2H15. RedHill recently submitted a European Marketing Authorization Application seeking approval of RHB-102 for cancer patients suffering from chemotherapy and radiotherapy-induced nausea and vomiting. Results are intended to support potential future submissions of marketing applications in both the U.S. and Europe for this indication. In parallel, RedHill is pursuing marketing approval for RHB-102 for the indications of chemotherapy and radiotherapy-induced nausea and vomiting in Europe and the U.S.

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