Talicia® Launched in the United Arab Emirates

Core Viewpoint - RedHill Biopharma has launched Talicia, the first approved low-dose rifabutin-containing all-in-one combination treatment for H. pylori infection, in the UAE, which opens up eligibility for additional milestone payments and royalties for the company [1][2]. Group 1: Product Launch and Market Impact - Talicia is now available by prescription in the UAE for adults with H. pylori infection, which affects 41% of the UAE population and over 50% of the global adult population [1][3]. - The launch of Talicia triggers RedHill's eligibility for potential milestone payments, minimum sales payments, and tiered royalties up to mid-teens on net sales [1][2]. - Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists for H. pylori treatment [1]. Group 2: Medical Need and Efficacy - H. pylori is a significant public health concern, being a major risk factor for gastric cancer, with traditional clarithromycin-based therapies showing declining effectiveness [2][4]. - A 2021 study indicated only 68.5% eradication with clarithromycin-based therapy, which dropped to 32% in patients with resistant H. pylori [2][3]. - Talicia demonstrated an 84% eradication rate in a pivotal Phase 3 study, significantly higher than the 58% rate in the active comparator arm [5][6]. Group 3: Product Composition and Resistance - Talicia is a fixed-dose combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole), specifically designed to combat high resistance rates of H. pylori to other antibiotics [4][5]. - Minimal to zero resistance to rifabutin was detected in the pivotal Phase 3 study, highlighting its effectiveness [5][6]. Group 4: Company Overview - RedHill Biopharma is a specialty biopharmaceutical company focused on gastrointestinal and infectious diseases, promoting Talicia for H. pylori and Aemcolo for travelers' diarrhea [9]. - The company is engaged in various late-stage development programs targeting multiple indications, including COVID-19 and oncology [9].