Dublin, Ireland - November 4, 2019 - Cosmo Pharmaceuticals N.V. (SIX: COPN) today informs that its partner RedHill Biopharma (NASDAQ: RDHL, Tel-Aviv Stock Exchange: RDHL) today announced that the U.S. Food and Drug Administration (FDA) has approved Talicia® (omeprazole magnesium1 10.3 mg, amoxicillin 250 mg and rifabutin 12.5 mg) delayed-release capsules for the treatment of Helicobacter pylori (H. pylori) infection in adults.
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.
Talicia® is eligible for 8 years of U.S. market exclusivity under QIDP designation, in addition to patent protection extending until 2034.
RedHill plans to launch Talicia®1 in the U.S. in Q1/2020 for the treatment for H. pylori infection in adults, targeting more than two million patients estimated to be treated for
H. pylori infection annually.
Cosmo announced on October 18, 2019, that it had taken a 19.56% stake in RedHill and had licensed out Aemcolo to RedHill.