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news.RedHill Biopharma has launched Talicia in the UAE, a treatment option for adults with Helicobacter pylori (H. pylori) infection.
Talicia benefits from eight years of US market exclusivity under its Qualified Infectious Disease Product designation. Credit: Martin Büdenbender from Pixabay.
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The launch may lead to additional milestone payments, minimum sales payments, and royalties for RedHill on net sales.
Talicia is the only low-dose rifabutin-based therapy which received approval for H. pylori infection and aims to combat the high antibiotic resistance of H. pylori bacteria.
A study conducted in 2021 highlighted the declining effectiveness of traditional clarithromycin-based triple therapy, with eradication rates dropping to 68.5%, and even further to 32% in patients with resistant H. pylori strains.
Unlike clarithromycin-based treatments, whose efficacy can be compromised by obesity or diabetes, Talicia’s safety and efficacy remain unaffected, as shown in post-approval post-hoc analysis.
The treatment is a fixed-dose oral capsule combining two antibiotics, amoxicillin and rifabutin, with a proton pump inhibitor, omeprazole.
Approved by the US Food and Drug Administration (FDA) in November 2019, Talicia showed an 84% eradication rate in the pivotal Phase III study, significantly outperforming the active comparator.
The study also reported minimal to zero resistance to rifabutin, a crucial component of Talicia.
Talicia benefits from eight years of US market exclusivity under its Qualified Infectious Disease Product designation and is protected by US patents until 2034, with further patents pending and granted in various territories worldwide.
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.”
