CPIX News & Events

Cumberland has entered into an agreement with an affiliate of Apotex, a Canadian based pharmaceutical company, to integrate their branded U.S. businesses. Under the terms of the agreement, Apotex will acquire Cumberland's line of branded pharmaceuticals for cash consideration of $100M, and create a platform aiming to deliver specialty medicines that improve the quality of patient care. The transaction is subject to authorization and approval by Cumberland's shareholders. Cumberland will retain its pipeline product candidates which it intends to focus on developing following the closing of the transaction. It will also retain its majority ownership position in Cumberland Emerging Technologies. In addition to its portfolio of FDA approved brands involved in the transaction with Apotex, Cumberland is developing ifetroban, a thromboxane antagonist through a series of programs designed to address unmet medical needs. The company has announced results in a Phase II clinical study of ifetroban in patients with cardiomyopathy associated with Duchenne muscular dystrophy. Interactions with the FDA are underway regarding the study results and remaining requirements for approval. The program has received Orphan Drug, Rare Pediatric Disease and more recently Fast Track designations from the FDA.

Cumberland has received approval from the FDA for an expanded indication for its Caldolor - ibuprofen - Injection product. The indication now includes the management of postoperative pain, and the approval coincides with the launch of a newly designed website for healthcare professionals highlighting this advancement and the evolving role of non-opioid pain management. With this update, Caldolor is indicated for use in adult and pediatric patients ages 3 months and older for: management of mild to moderate pain, including postoperative pain; management of moderate to severe pain, including postoperative pain, as an adjunct to opioid analgesics; reduction of fever. The newly launched Caldolor website aligns with this expanded indication, featuring dedicated content on postoperative pain management and the importance of multimodal, opioid-sparing approaches.

RedHill Biopharma (RDHL) announced that the full sales and operational launch of Talicia, under the joint commercialization agreement between Talicia Holdings, or THI, and Cumberland Pharmaceuticals (CPIX), has started and is now being rolled out to support accelerated market penetration and expanded reach. This marks the operational launch of the joint commercialization model previously announced in October 2025, including Cumberland's $4M strategic investment. "H. pylori infection affects 35% of the U.S. adult population and is a leading cause of gastric cancer, responsible for approximately 11,000 related U.S. deaths a year," said Rick Scruggs, President of THI and RedHill's COO. Talicia is the only FDA-approved all-in-one, low-dose rifabutin-based H. pylori therapy designed to address growing antibiotic resistance concerns to other available therapies. It is listed as a first-line H. pylori treatment option in the 2024 American College of Gastroenterology Clinical Guideline, which emphasizes using 14-day, "optimized" regimens for the first attempt to maximize cure rates and avoid the need for complex, less-effective salvage therapies4. It is patent protected through 2042 and received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product designation. Talicia is also the only FDA-approved medication for H. pylori infection with an all-in-one formulation, with the added benefit of simple dosing. RedHill continues to work towards expanding patient access to Talicia globally. Efforts focused on potential new market entries in the UK and the Middle East, along with work to further broaden market access and secure additional non-dilutive ex-U.S. licensing revenue streams, are ongoing.