FDA approves RedHill's innovative therapy Talicia to be marketed to treat adult patients infected with Helicobacter pylori

RedHill Biopharma(http:// announcedtoday that the U.SFDA(http://approved the launch of its innovative treatment Talician for the treatment of adult patients infected with Helicobacter pyloriTalicia is an FDA-approved Hifabutin-based Helicobacter pylori treatment designed to address Hpylori's resistance to commonantibiotics in standard care therapiesRedHill plans to bring Talicia to the U.Smarket in the first quarter of 2020Talicia is a new fixed-dose oral capsule formulated with two antibiotics: lifubutin and amoxicillin, and a proton pump inhibitor (PPI) omeprazolePreviously, the FDA has granted Talicia qualified infectious diseaseproduct seints(http://(QIDP) qualifications, priority review qualifications, and fast-track eligibilityTalicia's approval is based on positive results from two Phase 3 clinical studies The results of a validation 3 trial (http:// showed that 84 percent of patients treated with Taliciawas had H pylori infections removed, compared with 58 percent in the control group, with statistically significant differences 　　In addition, resistance to resistance to lifubutin, which is a key component of Talicia's unique formulation, was not detected in the trials (http:// to resistance to lifubutine