RedHill Biopharma to Submit FDA-Approved Talicia® for UK Marketing Authorisation

Core Insights - RedHill Biopharma plans to submit a UK Marketing Authorisation Application (MAA) for Talicia, targeting H. pylori infection, with potential approval by Q4 2025 [1][4] - Talicia is recognized as a first-line treatment option by the American College of Gastroenterology (ACG) and is the leading branded therapy for H. pylori in the U.S. [2][4] - H. pylori infection represents a significant market opportunity, affecting approximately 40% of the UK adult population and over 50% globally [1][3] Company Overview - RedHill Biopharma is a specialty biopharmaceutical company focused on developing and commercializing drugs for gastrointestinal diseases, infectious diseases, and oncology [7] - Talicia, approved by the FDA in November 2019, is a fixed-dose combination therapy that includes two antibiotics and a proton pump inhibitor [5] - The company is exploring commercialization partnerships to expand Talicia's market presence following approvals in the U.S. and UAE [4][5] Market Opportunity - H. pylori infection is a billion-dollar market, with significant prevalence in both the UK and globally, impacting treatment strategies and market dynamics [1][3] - The World Health Organization classifies H. pylori as a Group 1 carcinogen, linking it to a high incidence of gastric cancer and peptic ulcer disease [3][4] - Talicia's unique formulation addresses antibiotic resistance, a growing concern in H. pylori treatment, with efficacy rates reported as high as 90% [4][12]