RedHill Biopharma announced the full sales and operational launch of its flagship H. pylori therapy Talicia in the United States, marking the first commercial rollout of the drug under a joint commercialization agreement with Talicia Holdings Inc. and Cumberland Pharmaceuticals Inc.
Talicia, a low‑dose rifabutin‑based, all‑in‑one capsule, is the only FDA‑approved therapy that combines a full course of antibiotics into a single pill and is recommended as first‑line treatment in the 2024 American College of Gastroenterology guidelines. The launch follows a planned U.S. entry in Q1 2020 and a joint venture announcement in October 2025, and is expected to accelerate market penetration among the estimated 1.6 million U.S. patients treated annually for H. pylori.
Under the joint venture, RedHill holds a 70 % equity stake and will manage the launch and ongoing commercialization, while Cumberland contributes a $4 million strategic investment and commercial expertise. The partnership also benefits from Talicia’s patent protection through 2042 and eight years of U.S. market exclusivity under its QIDP designation, positioning the drug to capture a sizable share of the U.S. H. pylori treatment market.
The launch is part of RedHill’s broader strategy to achieve financial independence through robust commercial performance. By expanding the drug’s reach across the United States, the company aims to boost prescription volumes, strengthen its commercial portfolio, and generate the revenue growth needed to support future growth initiatives and global expansion plans, including recent licensing agreements in the Middle East and ongoing efforts in the UK.
RedHill’s management highlighted the launch as a key milestone in its commercialization roadmap, noting that the joint venture model will enable rapid scale and market access while leveraging Cumberland’s distribution network and RedHill’s clinical expertise. The company expects the launch to drive significant prescription uptake and reinforce its position as a leading branded H. pylori therapy in a market where antibiotic resistance remains a growing concern.
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