Cumberland Pharmaceuticals has acquired Hepatoren (ifetroban) injection, a Phase II development product, to treat hepatorenal syndrome involving kidney failure.
Cumberland’s acquisition includes rights to an extensive clinical database, non-clinical data package, manufacturing processes and intellectual property relating to ifetroban.
The company which has initiated the clinical development is evaluating the product to treat critically ill, hospitalised patients with hepatorenal syndrome.
Cumberland has received US Food and Drug Administration clearance for its investigational new drug submission.
Ifetroban was initially developed by Bristol-Myers Squibb for cardiovascular indications and seven Phase II trials were conducted for its own target indications.
Bristol-Myers Squibb donated the entire programme to Vanderbilt University, which further identified ifetroban’s potential in treating patients for several niche indications.
Cumberland acquired the ifetroban programme from Vanderbilt through its majority-owned subsidiary, Cumberland Emerging Technologies taking responsibility for development and commercialisation of the product.
The company plans to develop Hepatoren as an orphan drug and will pursue seven years of marketing exclusivity.
Patent applications had been filed to protect certain intellectual property related to the drug.
