$1.8M RedHill Deal Highlights Growing Worldwide Focus on H. pylori Treatment Access

RedHill Biopharma’s fixed-dose oral capsule marketed as Talicia, which combines the antibiotics amoxicillin and rifabutin and the proton pump inhibitor omeprazole, has been licensed for new Middle East markets in an agreement worth up to $1.8 million, plus sales royalty payments (1). RedHill, which has corporate headquarters in Tel Aviv and a United States hub located in Raleigh, NC, announced the deal on Oct. 6, 2025.

What is Talicia, what is H. pylori, and why does this treatment fill a need?

The all-in-one, low-dose rifabutin-based therapy is the only one of its kind approved by FDA that addresses resistance to other antibiotics commonly used to treat the bacterial infection Helicobacter pylori, which is a key risk factor for gastric cancer. According to RedHill, gastric cancer causes approximately 800,000 deaths per year globally; however, eradication of H. pylori could lead to a 75% decrease in gastric cancer risk (1).

In a press release announcing the agreement, RedHill said H. pylori, classified by the World Health Organization as a Group 1 carcinogen, affects approximately 35% of the US adult population, with an estimated 1.6 million people treated annually, rising to 50% worldwide and nearly 80% in parts of the Middle East (1). The infection is also a major risk factor for peptic ulcer disease and gastric mucosa-associated lymphoid tissue lymphoma.

Although H. pylori eradication is known to have a potential major impact on gastric cancer and other risks, current therapies fail in anywhere between 25% and 40% of patients, who remain H. pylori-positive because of the bacteria’s high resistance to antibiotics, including the standard therapy clarithromycin (1).

What could this agreement mean for global expansion of other treatments?

A strategic licensing agreement for specialized treatments such as this illustrates a global trend toward leveraging regional partnerships to secure non-dilutive revenue streams while targeting specific disease hotspots. It suggests a template for expanding other innovative therapies aimed at infectious diseases, particularly those known to be major risk factors for cancer. Addressing high-prevalence areas, such as the Middle East where H. pylori rates approach 4 in 5, demonstrates how targeted market building can fulfill significant unmet medical needs globally.

The broader global landscape demands diversified therapeutic strategies against complex conditions like gastric adenocarcinoma. This involves the concurrent advancement of both large biologic immunotherapies, which are rapidly expanding into curative-intent, earlier-stage disease settings, and novel small-molecule approaches. Small-molecule immuno-oncology agents, for example, offer potential synergy with existing biologics by targeting non-traditional immune pathways. For any modality to succeed internationally, the necessity for robust evidence standards and operational readiness is paramount, whether for a complex fixed-dose combination therapy or large biologic under priority review, based on thorough chemistry, manufacturing, and controls planning and data integrity from before the investigational new drug phase through commercial readiness.

Are other gastric cancer treatments available?

RedHill’s development of Talicia goes back more than a decade; in August 2015, the company reached an agreement under which Recipharm took manufacturing responsibility for the remaining supply of clinical trial material, and future commercial supply, for what was then a late-stage candidate known as RHB-105 (2).

In July 2025, FDA accepted and granted Priority Review for AstraZeneca’s supplemental Biologics License Application for Imfinzi (durvalumab) in combination with chemotherapy for perioperative treatment of adults with resectable Stage II–III gastric or gastroesophageal junction (GEJ) adenocarcinoma, with a Prescription Drug User Fee Act date set for the fourth quarter of 2025 (3). Meanwhile, gastric or GEJ adenocarcinoma is one of four tumor cohorts being examined in a Phase IIa clinical trial being conducted by Nxera Pharma and Cancer Research UK for HTL0039732/NXE0039732, an investigational small-molecule immunotherapy drug from Nxera (4).

The patent for Talicia is protected through 2042 and, in the US, the treatment received eight years of market exclusivity following its November 2019 FDA approval via a Qualified Infectious Disease Product designation (1).

References

1. RedHill Biopharma. RedHill Biopharma Signs New $1.8 Million Plus Sales Royalties Middle East Deal for Talicia. Press Release. Oct. 6, 2025.
2. Recipharm. Recipharm Signs Agreement with RedHill Biopharma for Manufacturing of RHB-105 for Treatment of H. pylori Infection. Press Release. Aug. 26, 2025.
3. Cole, C. AstraZeneca’s Imfinzi Advances in Gastric Cancer with FDA Priority Review. BioPharmInternational.com, July 28, 2025.
4. Mirasol, F. Cancer Research UK Partners with Nxera on Next-Stage Trial for HTL0039732. PharmTech.com, Sept. 17, 2025.