RedHill Biopharma Ltd. (NASDAQ: RDHL) announced plans to submit a UK Marketing Authorisation Application (MAA) for Talicia, its treatment for Helicobacter pylori (H. pylori) infection. The company will utilize the Medicines and Healthcare products Regulatory Agency's (MHRA) International Recognition Procedure (IRP), a fast-track regulatory process that references the existing U.S. Food and Drug Administration (FDA) approval, potentially securing UK approval as early as the fourth quarter of 2025.
H. pylori infection represents a significant global health burden, affecting approximately 40% of the UK adult population, 35% of U.S. adults, and over 50% of the global adult population. The World Health Organization (WHO) classifies H. pylori as a Group 1 carcinogen and identifies it as the strongest known risk factor for gastric cancer, contributing to 70-90% of cases. It is also responsible for 90% of peptic ulcer disease cases.
Addressing Antibiotic Resistance in H. pylori Treatment
Talicia stands out as the only FDA-approved all-in-one, low-dose rifabutin-based therapy specifically designed to combat H. pylori resistance to commonly used antibiotics. The American College of Gastroenterology (ACG) Clinical Guideline lists Talicia as a first-line treatment option, and it has become the leading branded H. pylori therapy prescribed by U.S. gastroenterologists.
Dror Ben-Asher, RedHill's Chief Executive Officer, highlighted the growing problem of antibiotic resistance: "The American College of Gastroenterology 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."
Clinical data supports Talicia's efficacy, with pivotal Phase 3 studies demonstrating 84% eradication of H. pylori infection compared to 58% in the active comparator arm (ITT analysis, p<0.0001). The treatment has shown minimal to zero rifabutin resistance in testing of 345 H. pylori isolates collected from patients in clinical trials.
Clinical Significance and Market Potential
The UK market represents a significant opportunity for RedHill, with approximately 40% of the adult population infected with H. pylori and 18 people diagnosed with gastric cancer daily. Studies have shown that confirmed eradication of H. pylori infection leads to a 75% decreased risk of gastric cancer.
"We are committed to expanding the global access and sales of Talicia following approvals in the U.S. and UAE, and planned UK submission, and we are exploring opportunities with potential commercialization partners in this global predicted billion-dollar market," said Ben-Asher.
Talicia's Formulation and Patent Protection
Approved by the FDA in November 2019, Talicia is a novel, fixed-dose, all-in-one oral capsule combining two antibiotics (amoxicillin and rifabutin) with a proton pump inhibitor (omeprazole). The medication is administered three times daily with meals, which the company states provides for easier adherence.
Talicia has received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is covered by U.S. patents extending protection until 2034. Additional patents and applications are pending or granted in various territories worldwide.
The drug is also approved by the United Arab Emirates Ministry of Health and was launched there by Ghassan Aboud Group in August 2024. RedHill notes that additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes, potentially expediting global commercialization.
Global Expansion Strategy
UK approval could serve as a stepping stone for broader international distribution, as some countries accept MHRA approvals as a reference for their own regulatory processes. This could accelerate RedHill's ongoing discussions with prospective territorial commercialization partners for Talicia.
The company's strategy aligns with growing concerns about antibiotic resistance in H. pylori treatment. Standard proton pump inhibitor-clarithromycin triple therapy fails in more than one in three patients when used against known clarithromycin-resistant strains, according to recent studies.
For patients and healthcare providers, Talicia offers a convenient FDA-approved three-times daily dosing regimen with meals, which may improve treatment adherence compared to more complex regimens.
