RedHill Biopharma Ltd. announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a new patent covering TALICIA® (RHB-105), which is expected to be valid until at least 2034. Once granted, this will be the fifth patent covering TALICIA® in the U.S., with additional patents and applications pending in various territories worldwide. TALICIA® is also eligible for a total of eight years of U.S. market exclusivity under its FDA Qualified Infectious Disease Product (QIDP) status. TALICIA® is a novel and proprietary fixed-dose, all-in-one oral capsule combination of two antibiotics, rifabutin and amoxicillin, and a proton pump inhibitor (PPI), omeprazole, that is being developed for the eradication of H. pylori infection. TALICIA® is expected to address the increasing resistance of H. pylori bacteria to the antibiotics commonly used in current standard-of-care therapies and the urgent need for new treatments, as defined by the World Health Organization. TALICIA® could potentially be positioned as the new standard-of-care, best-in-class, first-line therapy for the eradication of H. pylori infection, regardless of ulcer status, providing potential improved convenience and compliance with a favorable safety profile.RedHill recently announced positive results from a two-arm, randomized, double-blind, active comparator-controlled confirmatory Phase 3 study for H. pylori infection (ERADICATE Hp2 study). The ERADICATE Hp2 study successfully met its primary endpoint with high degree of statistical significance (p<0.0001), demonstrating 84% eradication of H. pylori infection with TALICIA® versus 58% in the active comparator arm in the intent-to-treat (ITT) population. No safety issues were reported in the study and TALICIA® was found to be well tolerated. H. pylori culture results taken throughout the ERADICATE Hp2 study from patients across 20 U.S. states confirmed the high resistance3 of H. pylori to the antibiotics most commonly used for treatment, clarithromycin (17% resistance) and metronidazole (44% resistance). Importantly, no resistance to rifabutin, the key component in TALICIA®’s unique and proprietary formulation, was detected in the study. Moreover, results from an open-label part of the ERADICATE Hp2 study showed 60% eradication of H. pylori in patients treated with physician-directed standard-of-care therapies, consistent with the literature describing their diminished efficacy, due to high resistance of H. pylori bacteria to the antibiotics commonly used in these therapies, primarily clarithromycin and metronidazole. TALICIA® was granted QIDP designation by the FDA, including Fast-Track development, eligibility for six-month priority review and a total of eight years of U.S. market exclusivity. RedHill expects to submit a New Drug Application (NDA) to the FDA in the first half of 2019 and plans the U.S. commercial launch of TALICIA® with RedHill’s existing salesforce for the second half of 2019, subject to FDA approval.