Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) and RedHill Biopharma Ltd. (Nasdaq: RDHL) announced strategic arrangements to jointly commercialize Talicia®, an FDA-approved oral capsule for treating Helicobacter pylori infection in adults. The bacterial infection represents a leading risk factor for gastric cancer, making this partnership significant for expanding treatment access.
Partnership Structure and Financial Terms
Under the agreement terms, Cumberland and RedHill will establish a new, jointly owned company. RedHill will contribute all Talicia assets to the venture, including the product's growing international licenses with associated revenues. Cumberland will provide $4 million in investment capital and assume responsibility for product distribution and sales recording.
The companies will equally share net revenues from Talicia, which generated $8 million in 2024. They plan to collaborate on all operational aspects, including sales, marketing, manufacturing, regulatory affairs, and supply chain functions. Cumberland will leverage its established national field sales force to lead promotional efforts and expand the product's reach among office-based healthcare providers.
"Talicia features an outstanding clinical profile and represents an excellent strategic match for our organization," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. "It provides us with an immediate growth opportunity, as we will build on the excellent foundation RedHill has created and bring this critical therapy to many more patients."
Clinical Profile and Regulatory Status
Talicia stands as the only all-in-one treatment containing omeprazole, amoxicillin, and rifabutin. The FDA approved the product based on two large Phase 3 studies demonstrating excellent safety and efficacy results. The treatment offers three key advantages: high eradication rates exceeding 90%, simplicity of an all-in-one capsule, and low resistance.
These attributes led to Talicia's inclusion as a first-line option in the newly updated American College of Gastroenterology guidelines for treating H. pylori infections. The product received FDA approval for H. pylori infection treatment in adults in November 2019.
"These arrangements represent an excellent opportunity for Cumberland, a highly capable and driven partner with a strong gastroenterology market presence, to add a market-leading approved product to its portfolio," said Rick Scruggs, Chief Commercial Officer of RedHill Inc.
Market Protection and Access
Talicia benefits from robust intellectual property protection, with patents extending through 2042. The product also received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation, providing significant competitive advantages.
Insurance coverage for Talicia spans broadly across the U.S. healthcare system, with 70% of American lives covered by commercial plans and 60% coverage through government plans. The product is dispensed by retail pharmacies nationwide, with a specific agreement ensuring CVS stocks the product at 1,700 of their pharmacy locations.
Company Portfolios and Strategic Focus
Cumberland Pharmaceuticals, the largest biopharmaceutical company founded and headquartered in Tennessee, focuses on delivering unique products that improve patient care quality. The company develops, acquires, and commercializes products for hospital acute care, gastroenterology, and oncology market segments.
RedHill Biopharma specializes in U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology. Beyond Talicia, RedHill's clinical pipeline includes late-stage development programs targeting various therapeutic areas, including opaganib for multiple indications and RHB-204 for Crohn's disease and pulmonary nontuberculous mycobacteria disease.
