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Tuesday, 10/12/2021 8:11:23 AM

Tuesday, October 12, 2021 8:11:23 AM

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RedHill Biopharma Announces New U.S. Patent Covering Talicia for H. pylori Infection Through 2034

https://finance.yahoo.com/news/redhill-biopharma-announces-u-patent-110000906.html

- The patent is directed to the Talicia® formulation and pharmaceutical kits for use in the treatment of H. pylori infection

- The new patent, valid through 2034, will be the fifth patent listed in the FDA Orange Book for Talicia

- Talicia is designed as a first-line option to address the high resistance of H. pylori bacteria to historical standard-of-care therapies

- H. pylori bacterial infection is a Group 1 carcinogen and the strongest risk factor for gastric cancer; H. pylori affects approximately 35% of the U.S. population


TEL AVIV, Israel and RALEIGH, N.C., Oct. 12, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the granting of U.S. Patent No. 11,135,172 covering Talicia, its U.S. approved medicine indicated for the treatment of H. pylori infection in adults. This patent reinforces the protection for Talicia through 2034, and the Company plans to list this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.

"Talicia's unique all-in-one capsule comprising a proton pump inhibitor and two antibiotics was approved by the U.S. FDA in November 2019 for the treatment of H. pylori infection in adults. Once listed, we will have five Orange-Book listed patents protecting Talicia," said Danielle T. Abramson, PhD., SVP, Global Head of Intellectual Property. "We continue to build an expansive international patent portfolio to protect this innovative formulation, which addresses increasing concerns of resistance related to clarithromycin and metronidazole and which supports ease of adherence and compliance by patients, provides a favorable tolerability and safety profile and is positioned to become the new first-line standard-of-care."
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