The Food and Drug Administration has approved an antibiotic drug designed to treat an infection that increases one’s risk of stomach cancer, but is becoming increasingly resistant to the current standard of care.
Tel Aviv, Israel-based RedHill Biopharma said Monday that the FDA had approved Talicia (omeprazole magnesium, amoxicillin, rifabutin) delayed-release capsules for treating Helicobacter pylori. The company plans to launch the drug in the first quarter of next year.
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The company describes the drug as the only rifabutin-based therapy for H. pylori infections and designed to address the bacteria’s resistance to standard-of-care therapies based on the drug clarithromycin. According to a 2015 study published in the journal Clinical Gastroenterology and Hepatology and based on a sample of 656 male veterans, H. pylori’s resistance to clarithromycin increased between 2009 and 2013. In addition, resistance to metronidazole remained high among infected men, while a high frequency of resistance to levofloxacin was called new and “concerning.”
Shares of RedHill were up more than 13 percent on the Tel Aviv Stock Exchange following the news.
“H. pylori is a major cause of peptic ulcer and gastritis. It is also carcinogenic and is the leading cause of gastric cancer,” University of Tennessee Health Science Center chief of the Division of Gastroenterology Dr. Colin Howden said in a statement. “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.”
RedHill announced positive top-line results from its Phase III confirmatory trial of Talicia in December 2018, showing that it successfully met its primary endpoint of eradicating H. pylori infection in 84 percent of patients, compared with patients in the active-comparator control arm, among whom the eradication rate was 58 percent.
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Bacterial resistance to antibiotics has emerged as perennial issue in recent years, threatening what some have called a potential “post-antibiotic world.” However, the challenge to creating new antibiotics is not necessarily scientific as much as it is economic. Because antibiotics are short-term therapies with relatively low prices and a limited shelf life, there is little incentive for companies to develop them, which has led to several companies going bust in the effort. One program the FDA has in place to encourage development of new antibiotics is the Qualified Infectious Disease Product designation, under which RedHill said Talicia is eligible for a total of U.S. market exclusivity, in addition to patent protection lasting at least until 2034.
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