RedHill's Talicia® Adds 8 Million Lives With Coverage by Humana®'s Part D Plan. Also, New Data Supporting Simplified Three-Times Daily Talicia Dosing Published

Core Insights - Talicia is now covered by Humana's Part D Plan, expanding access to over eight million Medicare lives for H. pylori therapy without prior therapeutic steps or authorizations [1][2] - The American College of Gastroenterology (ACG) Clinical Guideline has updated Talicia as a first-line treatment option for H. pylori infection, reinforcing its position as the most prescribed branded therapy by U.S. gastroenterologists [1][2] - New data published in the Journal of Clinical Pharmacology supports Talicia's recent FDA-approved label change to a more convenient three-times daily dosing regimen, enhancing patient adherence [1][3] Group 1: Talicia's Market Position - Talicia is the only FDA-approved low-dose rifabutin-based therapy for H. pylori eradication, highlighting its unique market position [2][7] - The drug demonstrated an 84% eradication rate in the pivotal Phase 3 study, significantly outperforming the 58% rate in the active comparator arm [8][29] - Talicia's pharmacokinetic profile remains consistent across dosing regimens, supporting its simplified TID dosing schedule [3][4] Group 2: H. pylori Infection Context - H. pylori infection affects approximately 35% of the U.S. adult population, with around two million patients treated annually [5][6] - The World Health Organization classifies H. pylori as a Group 1 carcinogen, making it a significant risk factor for gastric cancer and peptic ulcer disease [5][6] - Current therapies fail in approximately 25-40% of patients due to high resistance rates, particularly to clarithromycin, underscoring the need for effective treatments like Talicia [6][7] Group 3: Company Overview - RedHill Biopharma Ltd. focuses on the commercialization and development of drugs for gastrointestinal diseases, infectious diseases, and oncology [19] - The company is committed to enhancing patient experience and outcomes through innovative therapies like Talicia [3][4] - Talicia is eligible for eight years of U.S. market exclusivity under its Qualified Infectious Disease Product designation, with patent protection extending until 2034 [9]