RedHill Receives FDA Approval for H. Pylori Gastric Drug

Nasdaq and Tel Aviv-listed pharmaceutical company RedHill Biopharma Ltd. has received U.S. Food and Drug Administration (FDA) clearance for its new pill TALICIA, which provides antibiotic treatment of Helicobacter pylori gastric infections, the company announced in a Monday filing. H. pylori is a type of gastric bacteria linked with increased risks of developing ulcers and stomach cancer.

In December, RedHill announced a successful clinical trial in which TALICIA, composed of the antibiotics rifabutin and amoxicillin, managed to eradicate 84% of H. pylori bacteria, as opposed to 58% in patients receiving the standard of care. Founded in 2009, Tel Aviv-headquartered RedHill develops orally-administered medicine for gastrointestinal and inflammatory diseases. RedHill is traded at a market capitalization of $263 million after its price-per-share rose by 6.2% to $7.35, as of market close Monday.

RedHill intends to begin marketing TALICIA in the U.S. during the first quarter of 2020 and to expand its sales team from 40 to 140 by the end of the year, according to the statement.

According to RedHill CEO Dror Ben-Asher, more than half of the world’s population is infected with H. pylori. “This type of bacteria is developing ever-greater resistance to drugs and has doubled its resistance between 2009 and 2013,” he said in an interview with Calcalist Monday. “That's why we call it a super bacteria.”