Cumberland Pharmaceuticals Inc (Nasdaq:CPIX), a US-based specialty pharmaceutical company, announced on Monday that it has entered into strategic arrangements with RedHill Biopharma Ltd (Nasdaq: RDHL), an Israeli specialty biopharmaceutical company, to jointly commercialise Talicia.

The FDA-approved oral capsule is indicated for the treatment of Helicobacter pylori infection in adults, a bacterial infection and leading risk factor for gastric cancer.

Under the terms of the agreement, Cumberland and RedHill will form a new, jointly owned company. RedHill will contribute all its Talicia assets to the new company, including the product's international licenses with associated revenues, and Cumberland will provide USD4m in investment capital. Cumberland will assume responsibility for the product's distribution and record the product sales.

In 2024, Talicia generated net revenues of USD8m. The two companies have agreed to equally share net revenues and collaborate on all operational aspects, including sales, marketing, manufacturing, regulatory and supply chain functions. Through this co-commercialisation agreement, Cumberland says that it will leverage its established national field sales force to lead promotional efforts for Talicia and expand its reach among office-based healthcare providers.

Talicia is the only all-in-one treatment containing omeprazole, amoxicillin and rifabutin. It was approved by the FDA based on two large Phase 3 studies that demonstrated excellent safety and efficacy results. Talicia is now listed as a first-line option in the newly updated American College of Gastroenterology guidelines for the treatment of H. pylori infections. The product is patent protected until 2042 and received eight years of US market exclusivity under its Qualified Infectious Disease Product (QIDP) designation.

Talicia is dispensed by retail pharmacies across the country. An agreement with CVS provides for stocking of the product at 1,700 of their pharmacies.