RedHill To Submit UK MAA For Talicia For H. Pylori Infection, Referencing FDA Approval; Stock Down

(RTTNews) - RedHill Biopharma Ltd. (RDHL) announced Tuesday its plan to submit a UK Marketing Authorisation Application or MAA for Talicia for treatment of helicobacter pylori (H. pylori) infection. Utilizing the U.S. Food and Drug Administration approval of Talicia as reference, potential UK approval could be received as early as the fourth quarter of 2025.

In pre-market activity on the Nasdaq, the specialty biopharmaceutical company's shares were losing around 10.3 percent to trade at $2.70. On Monday's regular trading, the shares had gained 17.6% to $3.01.

The MAA has been submitted under the Medicines and Healthcare products Regulatory Agency's (MHRA) International Recognition Procedure (IRP), a fast-track regulatory process for UK drug approvals based on a recognized reference approval.

H. pylori infection is classified, by the World Health Organization, as a Group 1 carcinogen and the strongest known risk factor for gastric cancer and a major risk factor for peptic ulcer disease. It affects almost 40% of the UK population and over 50% of the global adult population.

Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole).

Talicia is the only FDA-approved all-in-one, low-dose rifabutin-based therapy designed to address H. pylori resistance to other antibiotics commonly used in H. pylori therapies. It is listed in the American College of Gastroenterology (ACG) Guideline as a first-line treatment option and is the number one branded H. pylori therapy prescribed by U.S. gastroenterologists.

The company noted that some additional countries may accept UK MHRA approvals as a reference for their own approval processes which could expedite ongoing discussions with prospective territorial commercialization partners for Talicia.

The FDA approved Talicia in November 2019 for the treatment of H. pylori infection in adults. Talicia has received eight years of U.S. market exclusivity.

The drug is also approved by the United Arab Emirates Ministry of Health and was launched there by Ghassan Aboud Group in August 2024.

Dror Ben-Asher, RedHill's Chief Executive Officer, said, "The American College of Gastroenterology (ACG) Guideline specifically recommends against the use of clarithromycin as part of any H. pylori treatment regimen without prior susceptibility testing.... We are committed to expanding the global access and sales of Talicia following approvals in the U.S. and UAE, and planned UK submission, and we are exploring opportunities with potential commercialization partners in this global predicted billion-dollar market."

For More Such Health News, visit rttnews.com