RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced that the full sales and operational launch of Talicia, under the joint commercialization agreement between Talicia Holdings Inc. (THI) and Cumberland Pharmaceuticals Inc., has started and is now being rolled out to support accelerated market penetration and expanded reach. This marks the operational launch of the joint commercialization model previously announced in October 2025, including Cumberland's $4 million strategic investment.
Focused on unlocking the full market potential of Talicia, the #1 branded US gastroenterologist-prescribed H. pylori therapy, THI, a RedHill and Cumberland jointly controlled operating entity (70/30 RedHill/Cumberland ownership) will manage the launch and ongoing joint commercialization, in coordination with Cumberland.
"H. pylori infection affects 35% of the US adult population and is a leading cause of gastric cancer, responsible for approximately 11,000 related US deaths a year," said Rick Scruggs, President of THI and RedHill's chief commercial officer. "Patients should have access to the most effective, clinically differentiated, therapies designed to eradicate H. pylori infection on the first attempt, while mitigating the risk of antibiotic resistance. We are excited to propel Talicia into its next phase of growth in this expanding market. We are integrating key commercial resources and leveraging our combined expertise to balance stronger prescription growth with the delivery of operational efficiencies as we drive to ensure that more patients benefit from this important therapy."
Talicia is the only FDA-approved all-in-one, low-dose rifabutin-based H. pylori therapy designed to address growing antibiotic resistance concerns to other available therapies. It is listed as a first-line H. pylori treatment option in the 2024 American College of Gastroenterology (ACG) Clinical Guideline, which emphasizes using 14-day, "optimized" regimens for the first attempt to maximize cure rates and avoid the need for complex, less-effective salvage therapies4. It is patent protected through 2042 and received eight years of US market exclusivity under its Qualified Infectious Disease Product (QIDP) designation. Talicia is also the only FDA-approved medication for H. pylori infection with an all-in-one formulation, with the added benefit of simple dosing.
RedHill continues to work towards expanding patient access to Talicia globally. Efforts focused on potential new market entries in the UK and the Middle East, along with work to further broaden market access and secure additional non-dilutive ex-US licensing revenue streams, are ongoing.
H. pylori is a bacterial infection that affects approximately 35% of the US adult population (an estimated 1.6 million US patients are treated annually) rising to more than 50% globally. Classified by the World Health Organization (WHO) as a Group 1 carcinogen, H. pylori is the strongest known risk factor for gastric cancer (between 70% to 90% of cases with more than 27,000 Americans diagnosed with gastric cancer annually5 and approximately 800,000 deaths globally per year), a major risk factor for peptic ulcer disease (90% of cases) and gastric mucosa-associated lymphoid tissue (MALT) lymphoma. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics, especially clarithromycin, which is still commonly used in standard combination therapies.
Approved by the FDA for the treatment of H. pylori infection in adults in November 2019, Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole). Talicia received eight years of US market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by US patents extending patent protection through 2042 with additional patents and applications pending and granted in various territories worldwide. Talicia is also approved by the United Arab Emirates (UAE) Ministry of Health.
RedHill Biopharma Ltd. is a specialty biopharmaceutical company primarily focused on US development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. |