RedHill Biopharma has said that Talicia (omeprazole magnesium, amoxicillin and rifabutin) is commercially launched in the United Arab Emirates (UAE).
The move will make Talicia available on prescription for treating Helicobacter pylori (H. pylori) infection in adults in the UAE.
According to the company, Talicia is the first approved low-dose rifabutin-containing all-in-one combination product specifically designed to treat H. pylori to be introduced in the UAE.
H. pylori is a bacterial infection classified by the World Health Organization (WHO) as a Group 1 carcinogen. It is considered a major risk factor for gastric cancer, peptic ulcer disease and gastric mucosa-associated lymphoid tissue (MALT) lymphoma.
As a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole), Talicia has demonstrated effectiveness against H. pylori.
In the Phase 3 study, Talicia reported 84% eradication of H. pylori infection in the intent-to-treat (ITT) group compared to 58% in the active comparator arm.
The prescription medicine was approved for use by the US FDA in November 2019 on adult patients suffering from H. pylori infection.
The launch of Talicia in the UAE makes RedHill eligible for potential milestone and sales payments along with tiered royalties on net sales.
RedHill Biopharma president and chief commercial officer Rick Scruggs said: “We are delighted with the commercial launch of Talicia in the UAE, bringing this important medicine to patients in the region.
“As one of the strongest risk factors for gastric cancer, H. pylori is a major public health concern. With 41% of the UAE population infected by H. pylori and the alarming failure rates of clarithromycin-based therapies, there is a significant medical need for a highly effective first-line H. pylori therapy.
“Our efforts to make Talicia available to patients in more countries continue as we work to explore additional opportunities with existing and potential partners.”
