RedHill Announces New USPTO Patent Grant for Talicia® for H. pylori Treatment Through 2042

RedHill Biopharma Ltd.recently announced the issuance of a new patent, U.S. Patent No. 11,878,011, granted by the U.S. Patent and Trademark Office (USPTO), providing protection for its product Talicia until May 2042. Talicia is a unique, all-in-one oral capsule developed for the eradication of Helicobacter pylori (H. pylori) infection in adults, regardless of their Body Mass Index (BMI).

The patent underscores the distinctive nature of Talicia in addressing the challenges associated with obesity, a factor known to be linked to the failure of certain H. pylori treatments. Gilead Raday, RedHill's Chief Operating Officer and Head of R&D, emphasized the clinical significance of Talicia's ability to remain effective across different BMI levels. Given that over 70% of the U.S. population is classified as overweight or obese, this innovation is vital for tackling H. pylori infections.

H. pylori is a bacterial infection that affects approximately 35% of the U.S. population and over 50% globally. It is classified as a Group 1 carcinogen by the World Health Organization (WHO) and is a significant risk factor for conditions such as gastric cancer, peptic ulcer disease, and gastric mucosa-associated lymphoid tissue (MALT) lymphoma.

Talicia, a combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole), has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of H. pylori infection in adults. It stands out as the only low-dose rifabutin-based therapy addressing H. pylori's high resistance to other antibiotics, particularly clarithromycin.

In pivotal Phase 3 studies, Talicia demonstrated an 84% eradication rate of H. pylori infection in the intent-to-treat group, surpassing the active comparator arm (58%). Minimal resistance to rifabutin, a key component of Talicia, was detected. Adherent subjects exhibited response rates of 90.3% in the Talicia arm compared to 64.7% in the active comparator arm.

Talicia is eligible for eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation, and U.S. patents extend protection until 2034, with additional patents and applications pending worldwide.

It is important to note that Talicia comes with specific safety considerations. Patients should inform healthcare providers about all medications taken, potential sensitivities, and existing medical conditions. Notable side effects include diarrhea, headache, nausea, stomach pain, rash, and indigestion. Talicia may also impact hormonal birth control effectiveness, and caution is advised regarding alcohol consumption.

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