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
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