Cumberland Pharmaceuticals Announces New Product Addition With Hepatorenâ„¢ (ifetroban) Injection
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 D