RedHill's Talicia Becomes Only Rifabutin-Based Therapy Approved for H. Pylori


Shares of RedHill Biopharma continue to climb in premarket trading this morning following Monday’s regulatory approval of Talicia, a treatment for Helicobacter pylori (H. pylori) infection in adults, regardless of ulcer status.

The U.S. Food and Drug Administration (FDA) approved the gastrointestinal-focused drug as a first-line treatment option for the more than two million people in the United States with the disorder. In clinical trials, Talicia demonstrated 90% efficacy in the eradication of H. pylori in studies and is the only rifabutin-based therapy on the market, RedHill said. Talicia (omeprazole magnesium, amoxicillin and rifabutin) is a novel, fixed-dose combination of two antibiotics, amoxicillin and rifabutin, and the proton pump inhibitor omeprazole. RedHill, which is headquartered in Tel Aviv and has its U.S. offices in Raleigh, N.C., plans to launch Talicia in the first quarter of 2020.

Dror Ben-Asher, chief executive officer of RedHill Biopharma, said the company is rapidly expanding its sales team to about 140 people in order to market Talicia, as well as the company’s other gastrointestinal treatments such as Aemcolo, a treatment for traveler’s diarrhea, which it licensed from Cosmo Pharmaceuticals NV last month.

H. pylori is a bacterial infection that affects approximately 35% of U.S. adult population. The approval comes at a time there is a significant global concern over bacterial resistance. H. pylori 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. Eradication of H. pylori is becoming increasingly difficult as the current standard-of-care therapies fail in approximately 25-40% of patients due to growing resistance to standard combination therapies, RedHill said.

Talicia is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria to current clarithromycin-based standard-of-care therapies. It is estimated that H. pylori resistance to clarithromycin more than doubled between 2009 and 2013.

David Graham, a professor of medicine, molecular virology and microbiology at Baylor College of Medicine and the lead investigator of the Talicia Phase III studies, said the RedHill drug provides a “much-needed treatment” for the H. pylori patients because it is not compromised by clarithromycin or metronidazole resistance.

“Studies with Talicia found zero resistance to rifabutin and showed 17% resistance to clarithromycin, a current standard-of-care macrolide antibiotic, consistent with current data showing that clarithromycin-containing therapies fail in approximately 25 to40% of cases,” Graham said in a statement.

Following the approval of Talicia and the licensing of Aemcolo, RedHill plans to hold an investor day conference on Nov. 22 to review launch plans and provide an overview of the company’s operations. The company noted that it has a debt-free balance sheet with approximately $59 million in cash and short-term investments.

Last month, RedHill reported positive news about its Crohn’s treatment. At 52 weeks, RHB-104 maintained consistent positive outcomes in a Phase III trial that it has shown in previous studies. The study met its primary endpoint of clinical remission at 26 weeks, with 36.7% of patients responding against 22.4% for placebo. It also hit its secondary endpoints of maintaining remission through 52 weeks, the company said. RHB-104 was found to be generally safe and well-tolerated.

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