RedHill Biopharma Ltd (RDHL)

[midastouch017]

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

RedHill plans to submit UK MAA1 for Talicia for H. pylori infection, using MHRA’s2 new fast-
track approval process, referencing FDA approval, with potential UK approval in Q4/25
--
Listed by ACG3 Clinical Guideline as a first-line option, Talicia is the leading branded H. pylori
therapy prescribed by U.S. gastroenterologists and the only FDA-approved all-in-one, low-dose
rifabutin-based therapy designed to address H. pylori resistance to other antibiotics
--
Talicia is also approved and launched in the UAE4 and additional countries may accept UK
MHRA approvals as a reference for their own marketing approval processes
--
H. pylori infection is a billion-dollar market opportunity affecting approximately 40% of the UK
adult population,5 a third of the U.S. adult population and over 50% of the global adult
population6

RALEIGH, N.C., March 18, 2025 -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced its plan to submit a UK Marketing Authorisation Application (MAA) for Talicia for treatment of helicobacter pylori (H. pylori) infection under the Medicines and Healthcare products Regulatory Agency’s (MHRA) International Recognition Procedure (IRP), a fast-track regulatory process for UK drug approvals based on a recognized reference approval. Utilizing the U.S. Food and Drug Administration (FDA) approval of Talicia as reference, potential UK approval could be received as early as the fourth quarter of 2025.

Talicia, the only FDA-approved all-in-one, low-dose rifabutin-based therapy designed to address H. pylori resistance to other antibiotics commonly used in H. pylori therapies, is listed in the American College of Gastroenterology (ACG) Guideline as a first-line treatment option and is the number one branded H. pylori therapy prescribed by U.S. gastroenterologists. Some additional countries may accept UK MHRA approvals as a reference for their own approval processes which could expedite ongoing discussions with prospective territorial commercialization partners for Talicia.

H. pylori infection affects approximately 35% of the U.S. adult population and over 50% of the global adult population7. It is classified, by the World Health Organization (WHO), as a Group 1 carcinogen and the strongest known risk factor for gastric cancer (causing between 70% to 90% of cases) and a major risk factor for peptic ulcer disease (causing 90% of cases)8.

Dror Ben-Asher, RedHill's Chief Executive Officer, said: “The American College of Gastroenterology (ACG) Guideline specifically recommends against the use of clarithromycin as part of any H. pylori treatment regimen without prior susceptibility testing. Resistance to both clarithromycin and levofloxacin, estimated at up to 40%, has been rising significantly and is linked to high H. pylori treatment failure rates – with more than one in three patients failing on standard proton pump inhibitor-clarithromycin triple therapy when used in the face of known clarithromycin resistance9. Talicia is now the leading prescribed branded H. pylori therapy by U.S. gastroenterologists, with the ACG Guideline listing it as first-line treatment option for H. pylori infection, based on Talicia’s proven superior efficacy – up to 90% effective - and safety, zero to minimal rifabutin resistance, and its convenient FDA-approved three-times daily (TID) ‘breakfast, lunch, and dinner’ dosing, providing for easier adherence.10,11,12 Almost 40% of the UK population are infected by H. pylori13,14 and 18 people are diagnosed with gastric cancer in the UK every day15, despite confirmed eradication of H. pylori infection leading to a 75% decreased risk of gastric cancer.16 We are committed to expanding the global access and sales of Talicia following approvals in the U.S. and UAE4, and planned UK submission, and we are exploring opportunities with potential commercialization partners in this global predicted billion-dollar market.”

About Talicia
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 has received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 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 and was launched there by Ghassan Aboud Group (GAG) in August 2024.