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Cumberland Pharmaceuticals Announces New Product Addition With Hepatoren™ (ifetroban) Injection

Stocks in this article: CPIX

NASHVILLE, Tenn., April 19, 2011 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company focused on hospital acute care and gastroenterology markets, today announced that it has entered into an agreement to acquire the rights to ifetroban, a new Phase II development product. The Company has initiated clinical development under the brand name Hepatoren™ (ifetroban) Injection and is evaluating the product for the treatment of critically ill hospitalized patients suffering from Hepatorenal Syndrome (HRS). Cumberland also has commenced manufacturing and received clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) submission associated with the product.

Hepatorenal Syndrome is a life-threatening condition involving progressive kidney failure. Approximately 450,000 patients in the United States suffer from medical conditions that make them susceptible to cirrhosis and a subset of these patients develop HRS every year. Decrease in kidney function causes nitrogen-containing waste products to build up in the bloodstream and ifetroban may improve renal function in HRS patients by increasing low renal blood flow. There is currently no drug approved for the treatment of HRS in the United States.

Cumberland's acquisition of the ifetroban program includes rights to an extensive clinical database and non-clinical data package as well as manufacturing processes, know-how and intellectual property related to the product. Ifetroban, an active thromboxane receptor antagonist, was initially developed by Bristol-Myers Squibb (BMS) for significant cardiovascular indications. BMS conducted extensive preclinical and clinical studies, including seven Phase II trials for its own target indications, and eventually donated the entire program to Vanderbilt University. Researchers at Vanderbilt's Department of Clinical Pharmacology identified ifetroban as a potentially valuable compound in treating patients for several niche indications.

Cumberland Pharmaceuticals acquired the ifetroban program from Vanderbilt through its majority-owned subsidiary, Cumberland Emerging Technologies (CET), assuming responsibility for development and commercialization of the product. CET facilitated the program transfer, which included product development activities at CET laboratories.

"This new product is an excellent strategic fit for our company given our established presence in hospital acute care," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "CET was created in conjunction with Vanderbilt University to serve as a source of innovative new biopharmaceutical products, and the ifetroban program represents a milestone for that organization. Cumberland Pharmaceuticals is extremely pleased to have another opportunity to provide a potential new solution to address an unmet medical need for critically ill patients."

Cumberland plans to develop ifetroban for a series of indications, initially focusing on the treatment of HRS for the hospital acute care market. In addition to commencing manufacturing, the Company has initiated a Phase II clinical study for the product. Cumberland intends to develop Hepatoren as an Orphan Drug for which the Company would pursue seven years of marketing exclusivity. Patent applications have also been filed to protect certain intellectual property related to the product.

About Ifetroban

Ifetroban is a pharmacological antagonist of the thromboxane A2 / prostaglandin endoperoxide receptor (TPR). Ifetroban exhibits high-affinity for TPRs on platelets, vascular smooth muscle and certain other cell types and lacks agonistic activity. Ifetroban also displays anti-platelet and antivasospastic activities and is effective in certain preclinical models of vasospasm, thrombosis, reperfusion injury and endothelial dysfunction, including models that are insensitive to aspirin.

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