CUMBERLAND PHARMACEUTICALS LAUNCHES U.S. PROMOTION OF TALICIA®

PR Newswire

NASHVILLE, Tenn., Feb. 25, 2026 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on developing new products for rare diseases, today announced the launch of its national sales promotional for Talicia^®.  Cumberland has assumed responsibility for the distribution and sales promotion of the brand in the U.S. under the co-commercialization agreement with RedHill Biopharma.

Talicia is an FDA-approved oral capsule indicated for the treatment of Helicobacter pylori infection in adults, a bacterial infection and leading risk factor for gastric cancer. Talicia is the only all-in-one treatment containing omeprazole, amoxicillin and rifabutin and is now listed as a first-line option in the American College of Gastroenterology guidelines for H. pylori infections. Talicia is patent protected through 2042 and received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product designation.

"We believe this represents an important catalyst for the next phase of Talicia's growth," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. "We are executing the full breadth of sales and marketing initiatives underway to support Talicia's continued momentum. Our focus is on strengthening prescription growth while expanding number of patients helped by this treatment."

The launch expands Cumberland's specialty product portfolio and reflects the company's strategy of leveraging its established commercial infrastructure to drive growth from its differentiated, FDA-approved brands. As part of the launch, Cumberland is utilizing its existing field sales force division with supporting marketing initiatives designed to increase awareness among gastroenterologists and other prescribing physicians.

H. pylori infection affects approximately 35% of the U.S. adult population and is a leading cause of gastric cancer, contributing to an estimated 11,000 related deaths annually in the U.S. Cumberland and its commercialization partner are aligning key commercial resources to ensure broader access to this clinically differentiated therapy.

About H. pylori
H. pylori is a bacterial infection that affects approximately 35% of the U.S. adult population (an estimated 1.6 million U.S. patients are treated annually) rising to more than 50% globally. Classified by the World Health Organization (WHO) as a Group 1 carcinogen, H. pylori is the strongest known risk factor for gastric cancer (between 70% to 90% of cases with more than 27,000 Americans diagnosed with gastric cancer annually and approximately 800,000 deaths globally per year), a major risk factor for peptic ulcer disease (90% of cases) and gastric mucosa-associated lymphoid tissue (MALT) lymphoma. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics, especially clarithromycin, which is still commonly used in standard combination therapies.

About Talicia^®
Approved by the FDA for the treatment of H. pylori infection in adults in November 2019, 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 received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents extending patent protection through 2042 with additional patents and applications pending and granted in various territories worldwide. Talicia is also approved by the United Arab Emirates (UAE) Ministry of Health.
For full prescribing information, visit www.talicia.com.

About Cumberland Pharmaceuticals

Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio of FDA-approved brands includes:

• Acetadote^® (acetylcysteine) injection, for the treatment of acetaminophen poisoning;
• Caldolor^® (ibuprofen) injection, for the treatment of pain and fever;
• Kristalose^® (lactulose) oral, a prescription laxative, for the treatment of constipation;
• Sancuso^® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment;
• Vaprisol^® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia;
• Vibativ^® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections; and
• Talicia^® (omeprazole, amoxicillin and rifabutin) oral capsule, for the treatment of H. pylori infection.

The company also has a series of Phase 2 clinical programs underway evaluating its ifetroban product candidate in patients with Systemic Sclerosis and Idiopathic Pulmonary Fibrosis, in addition to Duchenne muscular dystrophy.  For more information on Cumberland's approved products, including full prescribing information, please visit the individual product websites, which can be found on the company's website at www.cumberlandpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. Forward-looking statements include, among other things, statements regarding the company's intent, belief or expectations, and can be identified by the use of terminology such as "may," "will," "expect," "believe," "intend," "plan," "estimate," "should," "seek," "anticipate," "look forward" and other comparable terms or the negative thereof. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's operation results. These factors include macroeconomic conditions, including rising interest rates and inflation, competition, an inability of manufacturers to produce Cumberland's products on a timely basis, failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, natural disasters, public health epidemics, maintaining an effective sales and marketing infrastructure, and other events beyond the company's control as more fully discussed in its most recent annual report on Form 10-K as filed with the U.S. Securities and Exchange Commission ("SEC"), as well as the company's other filings with the SEC from time to time. There can be no assurance that results anticipated by the company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof.

SOURCE Cumberland Pharmaceuticals Inc.