Red Hill Receives FDA Approval for Talicia

The FDA has approved Raleigh-based RedHill Biopharma’s new drug to treat serious gastrointestinal infections after a priority review of the medication.

RedHill announced November 4 that the agency has given its ok for Talicia, which is used as a therapy for H. pylori bacterial infections. These infections impact more than 50% of the world’s population and approximately 35% – over 100 million – of the people in the United States. The World Health Organization classifies H. pylori as a Group 1 carcinogen, according to RedHill. 

H. Pylori infections pose a significant risk for peptic ulcer disease, gastric mucosa-associated lymphoid tissue lymphoma and gastric cancer. Yet the effectiveness of current treatments is on the decline due to the ever-increasing prevalence of antibiotic resistance. The market for therapies to treat H. pylori was close to $5 billion in 2015.

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’s indication for the treatment and eradication of H. pylori infection in the digestive tract is broader than most standard medicines. 

“The FDA’s approval of Talicia demonstrates our unwavering dedication to patients suffering from gastrointestinal diseases,” said Dror Ben-Asher, RedHill’s Chief Executive Officer. “We thank the patients, researchers and clinical staff who participated in the studies of Talicia and the RedHill team and vendors for this important milestone achieved by their commitment and hard work.”

Ben-Asher said the company will expand its current sales force of about 140 people and launch the drug in early 2020.

RedHill was established in 2009 in Tel Aviv, Israel and opened its U.S. headquarters and commercial operations in Raleigh in 2017. The company closed on a $20 million public offering in 2018 to bankroll the launch of Talicia. 

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.