Therapy Areas: Infectious Diseases
RedHill Biopharma adds Talicia to Contract Drug List (CDL) for H. pylori treatment, with no prior authorization
7 October 2021 -

Biopharmaceutical company RedHill Biopharma Ltd (Nasdaq:RDHL) reported on Wednesday the inclusion of the Talicia (omeprazole magnesium, amoxicillin and rifabutin) to its Contract Drug List (CDL) for H. pylori treatment, with no prior authorization required.

Effective 1 October 2021, the coverage for Talicia was initiated by the company's Medi-Cal - California's Medicaid Health Care programme covering 2m patients. H. pylori is a bacterial infection that affects 35% of the U.S. population, with about 2m patients treated annually.

The company said Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is covered by U.S. patents which extend patent protection until 2034.

According to the company, Talicia is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria to clarithromycin-based therapies. 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).

Under the company's pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat group vs 58% in active comparator arm. Minimal to zero resistance to rifabutin, a key component of Talicia, was also detected. The subjects who were confirmed adherent to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm.

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