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Company Description

Contact Info

2525 West End Avenue

Suite 950

Nashville, TN 37203

United States

Phone: 615-255-0068

Fax: 615-255-0094

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. The company markets and sells its approved products through its hospital and gastroenterology sales forces in the United States and are establishing a network of international partners to bring its products to patients in their countries. 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 injectable product approved in the United States for the treatment of both pain and fever. The U.S. Food and Drug Administration (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 completed a series of Phase IV studies to gather additional data to support its Caldolor product. 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. The company is responsible for the marketing, sale and distribution of the product. Vaprisol In 2014, the company entered into an agreement with Astellas Pharma US, Inc. (Astellas) to acquire Vaprisol, including certain product rights, intellectual property and related assets. Vaprisol is a patented, prescription brand indicated to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia. The company re-launched active promotion of the brand during the middle of 2014 utilizing its hospital sales force, which also features its Caldolor and Acetadote products. 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, a life-threatening condition involving progressive kidney failure for which there is no U.S. approved pharmaceutical treatment. Hepatoren (ifetroban) Injection is a Phase II candidate. Boxaban The company completed the manufacturing of an oral formulation of ifetroban and the FDA has cleared an IND amendment for this product candidate. The company initiated clinical development under the brand name Boxaban (ifetroban) capsules. The company initiated Phase II clinical study to evaluate Boxaban in patients suffering from aspirin-exacerbated respiratory disease. Strategy The key elements of the company’s strategy include continuing to build a high-performance sales organization to address its target markets; developing its existing products and develop new late stage product candidates; expanding its product portfolio by acquiring rights to additional products and late-stage product candidates; expanding its global presence through select international partnerships; and developing a pipeline of early-stage products through Cumberland Emerging Technologies. Trademarks and Patents The company is the owner of U.S. Patent No. 6,727,286, which is directed to ibuprofen solution formulations, methods of making the same, and methods of using the same, and which expires in 2021. The company has an exclusive, worldwide license to clinical data for intravenous ibuprofen from Vanderbilt University. During 2014, the company obtained additional patents for the brand. International Partnerships The company’s international strategy is to identify and partner with other companies that have the appropriate capabilities to support its products in their respective countries. The company’s international partners include Phebra Pty Ltd; Alveda Pharmaceuticals, Inc.; DB Pharm Korea Co., Ltd.; Alliance Pharm PTE Ltd.; bioCSL Pty Ltd; Sandor Medicaids Pvt. Ltd.; GerminMED; PT. SOHO Industri Pharmasi; PT. ETHICA Industri Farmasi; Laboratorios Grifols, S.A.; Gloria Pharmaceuticals Co. Ltd.; Clinigen Healthcare Limited; Laboratorios Valmorca, C.A.; and Al-Nabil International Ltd. Competition The company’s competitors in the acetaminophen overdose market are companies selling orally administered NAC, including Geneva Pharmaceuticals, Inc.; Bedford Laboratories division of Ben Venue Laboratories, Inc.; Roxane Laboratories, Inc.; InnoPharma Inc.; and Hospira Inc. History Cumberland Pharmaceuticals Inc. was incorporated in 1999.


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