RedHill gets FDA nod for drug to eradicate gut infection

Israeli firm plans to start selling the pill in the US in first quarter 2020, targeting more than 2 million patients treated for H. pylori infection annually; shares surge

Shoshanna Solomon was The Times of Israel's Startups and Business reporter

RedHill's RHB-105 or Talicia drug for H. pylori. (Courtesy)
RedHill's RHB-105 or Talicia drug for H. pylori. (Courtesy)

Israeli biopharmaceutical firm RedHill Biopharma Ltd. said Monday it has received US Food & Drug Administration approval to market its pill for the treatment of a bacterial infection that can cause ulcers and gastric cancer.

The firm, whose shares are traded on Nasdaq and the Tel Aviv Stock Exchange, said in a filing that it plans to launch the drug Talicia (also known as RHB-105) for the treatment of Helicobacter pylori (H. pylori) in adults in the US in the first quarter of 2020.

RedHill shares surged 30 percent at 1: 43 p.m. in Tel Aviv after the news.

The drug will target the estimated more than two million patients in the US who are treated for H. pylori infection annually, the statement said.

H. pylori affects approximately 35% of the US adult population; it is classified as a Group I carcinogen and is the strongest risk factor for the development of peptic ulcer disease, gastritis and non-cardia gastric cancer, the statement said.

“Treatment of H. pylori infection has become increasingly difficult due to growing bacterial resistance and the lack of advances in treatment options over the past decade,” said Dr. Colin Howden, Hyman professor of Medicine and chief of the Division of Gastroenterology, University of Tennessee Health Science Cente,r in the statement.

“Talicia offers a new effective treatment option to overcome bacterial resistance and provide optimal efficacy and I believe it could become a recommended first-line standard-of-care treatment for H. pylori infection.”

The fixed-dose oral capsule for the treatment of H. pylori infection is eligible for eight years of US market exclusivity, in addition to patent protection until at least 2034, according to a statement. The drug is a combination of two antibiotics, rifabutin and amoxicillin, and a proton pump inhibitor (PPI) called omeprazole.

Redhill’s two Phase 3 studies in the US, along with two additional pharmacokinetic studies, have shown the efficacy of Talicia in eradicating the H. pylori infection, with results of 84% and 89.4% compared with 70% for historical standard-of-care antibiotics used to treat the condition.

Talicia also addresses the increasing resistance of the H. pylori bacteria to the antibiotics commonly used in current standard-of-care therapies, triggering the necessity to develop new treatments.

Current standard-of-care antibiotic therapies fail in approximately 30-40% of patients who remain H. pylori positive, due to increasing resistance of the bacteria to the antibiotics commonly used to combat it.

“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,” said Dror Ben-Asher, chief executive officer of RedHill, in the statement.

The firm is now working to expand its sales force to 140 workers to promote Talicia and the other products of the firm, he said.

RedHill was founded by Dror Ben-Asher and Ori Shilo, two kibbutz dwellers turned investment bankers and entrepreneurs.

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