Redhill Biopharma Granted 5-Year Market Exclusivity for Antibiotic Treatment; Shares Surge 243%
Redhill Biopharma (Nasdaq: RDHL) has been granted five years’ market exclusivity for Talicia under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, by the FDA. Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists for eradication of H. pylori, a bacterial infection that affects approximately 35% of the U.S. adult population. The company’s share price rose 243% following the news.
RedHill’s Senior Vice President of Regulatory Affairs, Patricia Anderson, said, “Talicia is the only FDA-approved rifabutin-based therapy for the eradication of H. pylori. With significant concerns around maintaining effective therapeutic options for infectious diseases in the face of growing microbial resistance, it is vital that the most effective options are utilized first line. Talicia’s favorable efficacy, tolerability, and resistance profile, in the only all-in-one formulation available, provides potential advantages over clarithromycin-based regimens for most patients.”
Highlights
The FDA’s grant is on top of three years’ exclusivity granted for the approval of Talicia under section 505(b)(2). Talicia is protected by a broad intellectual property suite to 2034.
Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole), approved by the U.S. FDA for the treatment of H. pylori infection in adults.
Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034
- pylori is a bacterial infection that affects more than 50% of the population worldwide. It is classified by the WHO as a Group 1 carcinogen and is a strong risk factor for gastric cancer, peptic ulcer disease and gastric mucosa-associated lymphoid tissue (MALT) lymphoma.
About RedHill Biopharma
RedHill Biopharma Ltd. (NASDAQ: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults3, and Aemcolo®, for the treatment of travelers’ diarrhea in adults11. RedHill’s key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with a U.S. government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn’s disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease.
