RedHill Biopharma Ltd (NASDAQ:RDHL) revealed on Monday that it has increased unrestricted national and regional commercial coverage for its flagship drug Talicia – a three-drug combination of omeprazole magnesium, amoxicillin and rifabutin – to more than 40 million additional Americans, to treat Helicobacter pylori (H. pylori) infections in adults.
The Tel Aviv, Israel and Raleigh, North Carolina-based specialty biopharmaceutical company is primarily focused on gastrointestinal and infectious diseases.
“The unrestricted commercial coverage achieved for Talicia to date far exceeds our expectations at such an early stage following the product’s launch. We continue to work diligently to increase unrestricted coverage of Talicia, in an effort to make a significant difference in ending sub-optimal treatment of H. pylori,” said RedHill Chief Commercial Officer Rick Scruggs.
“Antibiotic resistance is a major issue in the treatment of H. pylori infections and yet, despite current guideline recommendations from the American College of Gastroenterology calling for use of the most effective first-line treatment, physicians are still prescribing treatment regimens containing antibiotics such as clarithromycin that face high levels of bacterial resistance,” he added.
RedHill has previously announced listings of Talicia as a preferred brand on the national formularies of Prime Therapeutics, EnvisionRx, and Express Scripts.
Significantly, 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 standard-of-care therapies. The significant rates of treatment failure with clarithromycin-based standard-of-care therapy is a strong public health concern, highlighted by the World Health Organization (WHO).
“This growth in unrestricted commercial access helps change that dynamic by increasing access to Talicia to more than 167 million Americans,” pointed out Scruggs.
Talicia is a novel, fixed-dose, all-in-one oral capsule containing two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole).
In November 2019, Talicia was approved by the US Food and Drug Administration (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 group versus 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to Talicia was detected in RedHill’s pivotal Phase 3 study. It was also observed that subjects who were confirmed adherents to their therapy had response rates of “90.3% in the Talicia arm versus 64.7% in the active comparator arm,” said the company.
Since Talicia enjoys the Qualified Infectious Disease Product (QIDP) designation for antibacterial drugs, it is eligible for eight years of post-approval US market exclusivity.
In addition, Talicia is protected by a robust US patent portfolio which provides patent protection until at least 2034, with additional patents and applications pending and granted in various territories worldwide.
H. pylori bacterial infection affects around 35% of the US population, with an estimated two million patients treated annually. What’s more, nearly 50% of the worldwide population is affected by H. pylori infection, which is classified by the WHO as a carcinogen and remains the strongest known risk factor for gastric cancer.
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive