Israeli biopharmaceutical firm RedHill Biopharma Ltd. on Monday announced the US launch of its pill for the treatment of a bacterial infection that can cause ulcers and gastric cancer.
The firm’s drug Talicia (also known as RHB-105) is for the treatment of Helicobacter pylori (H. pylori) bacteria in adults.
Redhill said Talicia’s target customers are some two million US patients treated annually for the infection, and it will promote the drug to 25,000 American gastroenterologists, primary care physicians and other healthcare providers.
US officials granted Talicia eight years of US market exclusivity and patent protection until 2034. It is the first FDA-approved drug for H. pylori in over a decade and has achieved 90 percent efficacy in Phase 3 trials, Redhill said.
The drug is a fixed-dose oral capsule made by combining two antibiotics, rifabutin and amoxicillin, and a proton pump inhibitor (PPI) called omeprazole.
H. pylori infections affect some 35% of Americans. It is a leading carcinogen, the most prominent known risk factor for gastric cancer, and a major contributor to peptic ulcer disease, gastritis and non-cardia gastric cancer, Redhill said. Over 50% of the world population is affected by the bacteria.
The infection is increasingly resistant to current antibiotics, making treatment difficult. Current standard-of-care antibiotic therapies fail in approximately 30-40% of patients, who remain H. pylori positive.
The FDA approved Talicia for use in November 2019.
The company is based in Tel Aviv and Raleigh, North Carolina. It trades on the Nasdaq under the ticker RDHL.
RedHill was founded in 2009 by Dror Ben-Asher and Ori Shilo, two kibbutz dwellers turned investment bankers and entrepreneurs.