Therapy Areas: Infectious Diseases
RedHill Biopharma secures USPTO Patent for Talicia, extending protection through 2034
11 March 2024 -

Specialty biopharmaceutical company focused on gastrointestinal and infectious diseases RedHill Biopharma Ltd. (NASDAQ: RDHL) announced on Monday the issuance of a new US patent expanding Talicia's IP portfolio.

This patent, effective until 12 February 2034, covers Talicia as a comprehensive treatment for H. pylori. Talicia boasts FDA approval as the sole rifabutin-containing all-in-one therapy for H. pylori, dominating as the primary first-line therapy prescribed by US gastroenterologists.

The new patent fortifies Talicia's existing protections, including composition of matter and FDA-granted data exclusivities under the GAIN QIDP designation and section 505(b)(2). H. pylori infection, affecting 35% of US adults, remains a significant concern, classified by the WHO as a Group 1 carcinogen.

Talicia addresses this issue with a novel fixed-dose combination of antibiotics and a proton pump inhibitor, achieving an 84% eradication rate in pivotal Phase 3 trials. With minimal rifabutin resistance observed, Talicia demonstrates promise in combating antibiotic resistance. Additionally, Talicia enjoys eight years of US market exclusivity under the QIDP designation and is bolstered by US patents extending protection until 2034, along with pending patents worldwide.