- The European and Japanese patent applications have been accepted and, once granted, are expected to be valid until 2034
- U.S. NDA for Talicia® on track for potential submission in H1/2019 and U.S. commercial launch in Q4/2019
- Talicia® was granted QIDP designation, including eligibility for six-month priority FDA review and a total of eight years of U.S. market exclusivity
RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on gastrointestinal (GI) diseases, today announced that both the European Patent Office (EPO) and the Japan Patent Office (JPO) have accepted pending patent applications covering Talicia® (RHB-105)1 for H. pylori infection.
Once granted, the new patents are expected to be valid until 2034. RedHill’s U.S. and worldwide intellectual property portfolio covering Talicia® includes nine issued patents and approximately 20 pending patent applications.
RedHill’s vice president of intellectual property and research, Danielle Abramson, Ph.D., said; “The allowance of these two new patents in Japan and Europe, together with the existing U.S. patent portfolio expected to be valid until 2034, is an important achievement as we continue to execute our intellectual property strategy and grow our robust worldwide patent protection for Talicia®. We expect to continue to strengthen and expand the breadth of our intellectual property towards the planned U.S. NDA submission for Talicia® in the first half of 2019.”
Talicia® is a novel and proprietary fixed-dose, all-in-one oral capsule combination of two antibiotics, rifabutin and amoxicillin, and a proton pump inhibitor (PPI), omeprazole, that is being developed for the eradication of H. pylori infection. Talicia® is expected to address the increasing resistance of H. pylori bacteria to the antibiotics commonly used in current standard-of-care therapies and the urgent need for new treatments, as defined by the World Health Organization2. Talicia® could potentially be positioned as the new standard-of-care, best-in-class, first-line therapy for the eradication of H. pylori infection, regardless of ulcer status, potentially providing improved convenience and compliance with a favorable safety profile.
Following the recently announced positive results from the two-arm, randomized, double-blind, active comparator-controlled confirmatory Phase 3 study for H. pylori infection (ERADICATE Hp2 study), RedHill is preparing to submit a U.S. New Drug Application (NDA) in the first half of 2019 and is planning for the U.S. commercial launch of Talicia® with RedHill’s existing sales force in the fourth quarter of 2019, subject to FDA approval.
The ERADICATE Hp2 study successfully met its primary endpoint with a high degree of statistical significance (p<0.0001), demonstrating 84% eradication of H. pylori infection with Talicia® versus 58% in the active comparator arm in the intent-to-treat (ITT) population. No safety issues were reported in the study and Talicia® was found to be well tolerated.
Talicia® was granted QIDP designation by the FDA, including Fast-Track development, eligibility for six-month priority review and a total of eight years of U.S. market exclusivity.
Source and full press release – https://ir.redhillbio.com/news-releases/news-release-details/redhill-biopharma-announces-new-european-and-japanese-patents