RedHill GI Infection Drug Gets Priority Review

The U.S. Food and Drug Administration has granted RedHill Biopharma priority review for its new drug to treat serious gastrointestinal infections. 

The Israeli specialty biopharmaceutical company, which has its U.S. headquarters and commercial operations in Raleigh, last year closed on a $20 million public offering to bankroll launch of the product, called Talicia.

The FDA will evaluate Talicia as a treatment for H. pylori bacterial infections, which affect more than 50% of the world’s population and approximately 35% -- over 100 million -- of the people in the U.S. The World Health Organization classifies H. pylori as a Group 1 carcinogen, according to RedHill. 

H. pylori poses a significant risk for peptic ulcer disease, gastric mucosa-associated lymphoid tissue lymphoma and gastric cancer. Yet the effectiveness of current drugs that treat the infection continues to decline due to the ever-increasing prevalence of antibiotic resistance.

The FDA has assigned a target action date for Talicia of November 2, 2019, which means potential approval by the end of this year. And that could lead to the growth of RedHill’s Raleigh-based staff. 

The company said it plans to launch the medicine soon after FDA approval, if it comes. “The acceptance for review of the NDA (new drug application) for Talicia, and the priority review designation, are encouraging steps as we continue our intensive preparations for a potential U.S. commercial launch...,” said RedHill CEO Dror Ben-Asher. “We continue to work closely with the FDA, with the aim of bringing this important new therapy to patients.”

Talicia is a fixed-dose, all-in-one oral capsule combination of two antibiotics --rifabutin and amoxicillin -- and a proton pump inhibitor (PPI), omeprazole. RedHill is pursuing an indication for the treatment and eradication of H. pylori infection that is broader than most standard medicines. 

The company was established in 2009 in Tel Aviv and opened its U.S. headquarters in Raleigh in 2017. RedHill is focused primarily on late clinical-stage development and commercialization of drugs to treat gastrointestinal diseases and cancer. Its shares are traded on the Nasdaq stock market and the Tel Aviv Stock Exchange.