10.11.2014 13:48:49
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RedHill Biopharma's H. Pylori Drug Gets QIDP Fast-Track Designation
(RTTNews) - RedHill Biopharma Ltd. (RDHL) Monday said its Helicobacter pylori drug, RHB-105, has been granted Qualified Infectious Disease Product designation by the U.S. Food and Drug Administration.
The QIDP designation gives RHB-105 a fast-track development and priority-review status, and, if approved, additional five years of market exclusivity in the U.S.
RHB-105, a combination of two antibiotics and a proton pump inhibitor, is undergoing a Phase 3 trial for which top-line data is due to published in the second quarter of 2015.
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