RedHill's Talicia, the first approved low-dose rifabutin-containing all-in-one combination treatment for H. pylori, is now available on prescription to treat adults with H. pylori infection in the United Arab Emirates (UAE) The commercial launch of Talicia triggers RedHill's eligibility for additional potential milestone payments, minimum sales payments and tiered royalties up to mid-teens on net sales Talicia is the leading branded first-line therapy prescribed by U.
S. gastroenterologists [1] for the treatment of H. pylori, a bacterial infection that affects 41% of the UAE population [2] and over 50% of the world's adult population [3] RALEIGH, N.
C. , Aug. 21, 2024 /PRNewswire/ -- RedHill Biopharma Ltd.
(Nasdaq: RDHL ) (" RedHill " or the "Company"), a specialty biopharmaceutical company, today announced the launch of Talicia (omeprazole magnesium, amoxicillin and rifabutin) [4] in the United Arab Emirates (UAE) – making it available by prescription to treat adults with Helicobacter pylori ( H. pylori ) infection. The commercial launch of Talicia in the UAE triggers RedHill's eligibility for additional potential milestone payments, minimum sales payments and tiered royalties up to mid-teens on net sales.
Talicia is the first approved low-dose rifabutin-containing all-in-one combination product in the UAE specifically designed to treat H. pylori . "We are delighted with the commercial launch of Talicia in the UAE, bringing this important medicine to patients in the region," said Rick Scruggs , President, RedHill Biopharma Inc.
& Chief Commercial Officer . "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 [5],[6] , 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." 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 [7] . Clarithromycin-based treatment efficacy can also be negatively impacted by patient obesity or diabetic status, neither of which impact Talicia's safety or efficacy, according to data from post-approval post-hoc analysis [8],[9] .
About H. pylori H. pylori is a bacterial infection that affects approximately 35% [10] of the U.
S. population, with an estimated two million patients treated annually [11] . Worldwide, more than 50% of the population has H.
pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer [12] and a major risk factor for peptic ulcer disease [13] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma [14] . More than 27,000 Americans are diagnosed with gastric cancer annually [15] .
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 therapies [16] . About Talicia Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H.
pylori bacteria seen with 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 by the ACG, FDA and the World Health Organization (WHO) in recent years.
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). In November 2019 , Talicia was approved by the U.S.
FDA for the treatment of H. pylori infection in adults. 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 (p250 hours after the last dose. [18] The pivotal Phase 3 study with Talicia ® demonstrated 84% eradication of H.
pylori infection with Talicia ® vs. 58% in the active comparator arm (ITT analysis, p<0.0001).
[19] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.
Talicia.com . [20] Aemcolo ® (rifamycin) is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults.
For full prescribing information see: www.Aemcolo.com .
SOURCE RedHill Biopharma Ltd..
