Cumberland Pharmaceuticals Inc., a specialty pharmaceutical company, focuses on the acquisition, development, and commercialization of branded prescription products. The company’s primary target markets are hospital acute care and gastroenterology. It markets and sells its approved products through its hospital and field sales forces in the United States, which together comprised approximately 60 sales representatives and managers as of December 31, 2013. It markets four products approved for sale in the United States. Products The company’s product portfolio includes Acetadote (acetylcysteine) Injection, for the treatment of acetaminophen poisoning; Caldolor (ibuprofen) Injection, for the treatment of pain and fever; Kristalose (lactulose) for Oral Solution, a prescription laxative, for the treatment of chronic and acute constipation; Omeclamox-Pak, triple therapy combination medication for Helicobacter pylori (H. pylori) infection and duodenal ulcer disease; and Hepatoren (ifetroban) Injection, a Phase II candidate for the treatment of hepatorenal syndrome. Acetadote Acetadote is an intravenous formulation of N-acetylcysteine (NAC) indicated for the treatment of acetaminophen poisoning. Acetadote is used in hospital emergency departments to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in various over-the-counter and prescription pain relieving and fever-reducing products. Caldolor Caldolor, the company’s intravenous formulation of ibuprofen, is the first injectable product approved in the United States for the treatment of both pain and fever. The FDA approved Caldolor for marketing in the United States following a priority review. The product is indicated for use in adults for the management of mild to moderate pain, for the management of moderate to severe pain as an adjunct to opioid analgesics, and for the reduction of fever. The company has worldwide commercial rights to Caldolor. Kristalose Kristalose is a prescription laxative administered orally for the treatment of constipation. A dry powder crystalline formulation of lactulose, Kristalose is designed to improve patient compliance and acceptance. The company owns the U.S. commercialization rights to Kristalose, assembled a dedicated field sales force and re-launched the product as a Cumberland brand. The company directs its sales efforts to physicians who are the most prolific writers of prescription laxatives, including gastroenterologists, pediatricians and internists. Omeclamox-Pak Omeclamox-Pak is a branded prescription product used for the treatment of Helicobacter pylori (H. pylori) infection and duodenal ulcer disease. This product combines three prescribed medications, such as omeprazole, clarithromycin, and amoxicillin. Hepatoren The company has an agreement to acquire the rights to ifetroban, a new Phase II product candidate. It has initiated clinical development under the brand name, Hepatoren (ifetroban) Injection and is evaluating this candidate for the treatment of critically ill hospitalized patients suffering from hepatorenal syndrome (HRS), a life-threatening condition involving progressive kidney failure for which there is no U.S. approved pharmaceutical treatment. International Partnerships The company’s international partners, licensed product rights and territories include Alveda Pharmaceuticals; Phebra Pty Ltd; DB Pharm Korea Co. Ltd; Harbin Gloria Pharmaceuticals Co. Ltd; Sandor Medicaids Pvt. Ltd.; GerminMED; PT. SOHO Industri Pharmasi; PT. ETHICA Industri Farmasi; Grifols; Valmorca; and Al-Nabil International. Strategy The company’s strategy includes improving the potential of its existing products and selectively expanding its portfolio of differentiated products. Its strategy is to continue to build a high-performance sales organization to address its target markets; expand its product portfolio by acquiring rights to additional products and late-stage product candidates; expand its global presence through select international partnerships; and developing a pipeline of early-stage products through Cumberland Emerging Technologies, Inc. History Cumberland Pharmaceuticals Inc. was incorporated in 1999.
2525 West End Avenue
Nashville, TN 37203
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