Today before the opening bell, Cumberland Pharmaceuticals Inc., a specialty pharmaceutical company focused on hospital acute care and gastroenterology markets, announced that it has signed an agreement to acquire the rights to ifetroban, a new Phase II development product. Cumberland acquired Ifetroban from Vanderbilt through its majority-owned subsidiary, Cumberland Emerging Technologies (CET).
Under the brand name Hepatoren™ (ifetroban) Injection, the company has initiated clinical development and is evaluating the product for the treatment of critically ill hospitalized patients suffering from Hepatorenal Syndrome (HRS). Cumberland has already 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 medical condition that consists of rapid deterioration in kidney function. Almost a half a million 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. As of right now, there are no drugs approved for the treatment of HRS in the United States.
“This new product is an excellent strategic fit for our company given our established presence in hospital acute care,” stated 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 intends to develop ifetroban for a series of indications, but is initially focusing on the treatment of Hepatorenal Syndrome for the hospital acute care market. The company has commenced manufacturing and initiated a Phase II clinical study for the product. Cumberland plans to develop Hepatoren as an Orphan Drug. Patent applications have also been filed to protect paticular intellectual property related to the product.