RedHill Biopharma Announces Talicia Approved in the United Arab Emirates and First Commercial Order Outside the U.S.

RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced that its partner, Gaelan Medical LLC, a wholly owned subsidiary of the Ghassan Aboud Group (GAG), has received marketing approval from the United Arab Emirates (UAE) Ministry of Health for Talicia (omeprazole magnesium, amoxicillin and rifabutin). The approval makes Talicia the first approved rifabutin-containing all-in-one combination product in the UAE specifically designed to treat H. pylori.

“We are delighted with the rapid progress our partner, Gaelen Medical, has made in achieving marketing approval for Talicia in the UAE, and we are pleased to have received the first commercial order for Talicia from Gaelen,” said Adi Frish, RedHill’s Chief Corporate & Business Development Officer. “H. pylori is a major public health concern in the region, impacting up to 84% of the population, and is one of the strongest risk factors for gastric cancer. Considering the alarming failure rates of clarithromycin-based therapies and the need for highly effective first-line H. pylori therapy, we continue our efforts to help bring Talicia to H. pylori patients in additional countries as we continue to explore, with GAG and other potential partners, the expansion of Talicia’s reach into new territories.”

Clarithromycin-based triple therapy continues to wane in effectiveness. A 2021 study demonstrated only 68.5% eradication with traditional clarithromycin-based triple therapy, which declined further to 32% in patients harboring resistant H. pylori organisms. Other studies have also shown that for clarithromycin-resistant strains of H. pylori the risk of eradication failure increases 3-7–fold when treated with clarithromycin-containing regimens. Clarithromycin-based treatment efficacy can also be negatively impacted by patient BMI or diabetic status, neither of which impact Talicia’s eradication rates, according to data from post-approval post-hoc analysis.