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RedHill Biopharma Signs New $1.8 Million Plus Sales Royalties Middle East Deal For Talicia®

Core Insights - The licensing agreement for Talicia aims to enhance its market presence in the Middle East, with a total potential value of $1.8 million plus sales royalties [1][2]. Financial Terms - RedHill will receive $500,000 in guaranteed payments, which includes a $250,000 upfront payment and another $250,000 in fixed payments due within 18 months [2]. - There is a potential for a minimum of $1.3 million in near-term milestone payments, along with tiered royalties that could reach mid-teens percentage on Talicia's net sales [2]. Product Overview - Talicia is the only FDA-approved all-in-one, low-dose rifabutin-based therapy specifically targeting H. pylori antibiotic resistance [1][4]. - It is the leading branded therapy prescribed by U.S. gastroenterologists for H. pylori and is recognized as a first-line treatment in the American College of Gastroenterology Clinical Guidelines [4]. Market Need - H. pylori infection affects over 50% of the global adult population, with rates nearing 80% in certain Middle Eastern regions, and is classified as a Group 1 carcinogen by WHO, significantly increasing the risk of gastric cancer [1][6]. - Effective treatment for H. pylori is critical, especially given the rising antibiotic resistance, which complicates treatment regimens that include clarithromycin [3][6]. Clinical Efficacy - Talicia has demonstrated an efficacy rate of up to 90% in eradicating H. pylori, with a significant advantage over traditional therapies that may fail in 25-40% of cases due to antibiotic resistance [3][6]. - The eradication of H. pylori can lead to a 75% reduction in gastric cancer risk, highlighting the importance of effective treatment options [3]. Intellectual Property - Talicia is protected by patents until 2042 and has received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product designation [5][9].