This morning Tel Aviv-based specialty biopharmaceutical company RedHill Biopharma Ltd. (RDHL:NASDAQ), which is focused on the development and commercialization of proprietary drugs for the treatment of gastrointestinal diseases, announced that "the U.S. Food and Drug Administration (FDA) has approved Talicia® (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10 mg/250 mg/12.5 mg for the treatment of Helicobacter pylori (H. pylori) infection in adults." The company stated its sales force expects to launch Talicia in the U.S. in Q1/20.
The firm advised in the release "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 2009-2013."
RedHill Biopharma's CEO Dror Ben-Asher commented, "The FDA's approval of Talicia demonstrates our unwavering dedication to patients suffering from gastrointestinal diseases...We are working to expand our sales force to approximately 140 representatives who will promote Talicia, Aemcolo and other gastrointestinal-focused products in our basket."
Lead investigator of the Talicia Phase 3 studies, David Y. Graham, MD, MACG, professor of medicine, molecular virology and microbiology at Baylor College of Medicine in Houston, stated, "Talicia offers patients a much-needed new treatment option for H. pylori with an excellent safety and efficacy profile that is not compromised by clarithromycin or metronidazole resistance. The clinical studies for Talicia demonstrated high efficacy in eradication of H. pylori. 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 25-40% of cases."
In addition, Colin W. Howden, MD, AGAF, FACG, Hyman Professor of Medicine & chief of the Division of Gastroenterology at the University of Tennessee Health Science Center, added, "H. pylori is a major cause of peptic ulcer and gastritis. It is also carcinogenic and is the leading cause of gastric cancer. 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. 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 company advises in the report that H. pylori bacterial infection is classified as a Group I carcinogen by the International Agency for Research on Cancer that affects over 50% of the population worldwide and approximately 35%, or over 100 million people, in the U.S., with an estimated 2.5 million patients treated annually in the U.S.
The firm further explains in the release that "Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults."
RedHill Biopharma is a specialty biopharmaceutical company focused on the development and commercialization of late clinical-stage, proprietary, orally administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. The company commercializes and promotes several gastrointestinal products in the U.S., including Donnatal, EnteraGam and Mytesi, and plans to also launch Aemcolo and Talicia in the U.S.
RDHL ADR shares opened higher today at $8.43 (+$1.51, +21.82%) over Friday's $6.92 closing price. The stock has traded today between $7.28 to $8.55 per share and is currently trading at $7.65 (+0.83, +11.99%).
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