ir.redhillbio.com/node/13986/pdf
RedHill Biopharma Announces FDA Approval of Talicia® for Treatment of H. pylori in Adults
November 4, 2019
RedHill plans to launch Talicia®1
in the U.S. in Q1/2020 for the treatment of H. pylori infection in adults, targeting
more than two million patients estimated to be treated for H. pylori infection annually
Talicia® is the first and only FDA approved rifabutin-based H. pylori therapy and is designed to address the high
and growing bacterial resistance and diminished efficacy of clarithromycin-based standard-of-care therapy
H. pylori affects approximately 35% of U.S. 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
Talicia® is eligible for 8 years of U.S. market exclusivity under QIDP designation, in addition to patent protection
extending until 2034
Debt-free balance sheet with approximately $59 million in cash and short-term investments following a recent
strategic investment by Cosmo Pharmaceuticals
RedHill will host Investor and Analyst day and live webcast on November 22, 2019 to present its planned
commercial launch of Talicia® and Aemcolo®