TEL AVIV, Israel and RALEIGH, N.C. - RedHill Biopharma Ltd. (NASDAQ: NASDAQ:RDHL), a specialty biopharmaceutical company, has been granted a new U.S. patent for Talicia, its treatment for Helicobacter pylori (H. pylori) infection. The United States Patent and Trademark Office (USPTO) issued the patent, which is expected to extend Talicia's protection until February 12, 2034.
The patent covers Talicia as an all-in-one fixed-dose combination therapy consisting of amoxicillin, omeprazole, and rifabutin. This formulation is the only FDA-approved treatment containing rifabutin for H. pylori eradication. It is designed to address the growing concern of antibiotic resistance, particularly to clarithromycin, which is commonly used in other H. pylori treatment regimens.
Talicia is recognized as the leading branded first-line therapy prescribed by U.S. gastroenterologists for H. pylori, a bacterial infection affecting around 35% of the U.S. adult population. The new patent complements an existing portfolio of intellectual property rights that includes several other patents and FDA-granted data exclusivities under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation and section 505(b)(2).
Patricia Anderson, RedHill's Senior Vice President of Regulatory Affairs, emphasized the importance of Talicia's optimized resistance profile in the face of increasing microbial resistance to other treatment regimens. The company's pivotal Phase 3 study showed an 84% eradication rate of H. pylori infection with Talicia in the intent-to-treat group.
H. pylori infection is a significant global health concern, with more than 50% of the world's population infected and strong links to gastric cancer, peptic ulcer disease, and gastric mucosa-associated lymphoid tissue (MALT) lymphoma. Current treatments fail in approximately 25-40% of patients who remain H. pylori-positive due to antibiotic resistance.
The information in this article is based on a press release statement from RedHill Biopharma Ltd.
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