TEL AVIV - RedHill Biopharma Ltd. (Nasdaq: RDHL) ('RedHill' or the 'Company'), a specialty biopharmaceutical company, today announced that the U.S. Patent and Trademark Office (USPTO) issued a new patent, U.S. Patent No. 11,878,011, covering Talicia as a method for eradicating Helicobacter pylori (H. pylori) regardless of patient Body Mass Index (BMI).

This new patent is expected to provide protection for Talicia until May 2042.

'Rates of obesity continue to rise in the U.S., with over 70% of the population being overweight or obese[6], and published data have shown that obesity has been associated with failure of clarithromycin-based therapies for the treatment of H. pylori infection. This patent acknowledges the novelty of the data demonstrating Talicia's ability to remain effective regardless of patient BMI, awarding this clinically important innovation with expected patent protection for Talicia until May 2042' said Gilead Raday, RedHill's Chief Operating Officer, and Head of R&D.

About H. pylori infection

H. pylori is a bacterial infection that affects approximately 35% of the U.S. population, with an estimated two million patients treated annually[7]. Worldwide, more than 50% of the population has H. pylori infection, which is classified by the World Health Organization (WHO) as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[8] and a major risk factor for peptic ulcer disease[9] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[10]. More than 27,000 Americans are diagnosed with gastric cancer annually[11]. 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 therapies5.

About Talicia

Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole), approved by the U.S. Food and Drug Administration (FDA) for the treatment of H. pylori infection in adults.

Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address H. pylori's high resistance to other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted American College of Gastroenterology, the FDA and the WHO in recent years.

In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p

(C) 2024 Electronic News Publishing, source ENP Newswire