TEMECULA, Calif., Oct. 9 /PRNewswire/ -- FFF Enterprises Inc., a multidimensional healthcare corporation based in Temecula, Calif., and LifeTree eClinical, FFF’s clinical services division, today announced the company has signed an agreement with OMRIX Biopharmaceuticals, Inc. (“OMRIX”) headquartered in New York, NY. FFF will provide support of a Phase III clinical trial of Omr-IgG-am(TM), OMRIX’s intravenous immunoglobulin, for the treatment of primary immune deficiency diseases (PIDD). Omr-IgG-am is currently marketed outside of the United States.
FFF will use LifeTree’s e-clinical data capture services suite to manage the Omr-IgG-am study, the purpose of which is to investigate the efficacy, pharmacokinetics, safety and overall tolerability of Omr-IgG-am, and to determine, on the basis of historical data, whether it is equivalent to immune globulin products currently licensed in the United States for the treatment of subjects with PIDD.
Upon FDA approval of the biologics license application (BLA) for Omr-IgG-am in the United States, FFF will become the product’s exclusive authorized distributor for five years.
“We are pleased to be participating in the search for additional therapies for the treatment of primary immune deficiency diseases,” said Patrick M. Schmidt, FFF Enterprises president and CEO. “With so many physicians and patients reporting problems with access to immune globulin products, this contract could not have come at a better time: It will allow us to showcase our clinical trials management and secure distribution services, while helping our hospital and physician practice customers better serve the patients who rely on this lifesaving therapy.
“And, our commitment to channel integrity will ensure that Omr-IgG-am is distributed with the utmost safety and care,” Schmidt continued.
About FFF Enterprises
FFF Enterprises, founded in 1988, is a multidimensional healthcare company, delivering innovative solutions in biopharmaceutical management and distribution, health information management and consumer healthcare services. FFF is the nation’s largest supplier of biopharmaceuticals, plasma products, vaccines and clinical trial drugs. Customers of FFF’s four divisions include members of the leading U.S. acute care and non-acute care group purchasing organizations, government agencies, pharmaceutical manufacturers, contract research organizations, managed healthcare and consumers.
FFF’s unique distribution business model has institutionalized Guaranteed Channel Integrity(TM), which reflects the company’s commitment to purchase only from manufacturers and ship only to healthcare providers. This protects products and patients from the risks of counterfeiting, diversionary practices and irresponsible pricing inherent in secondary and gray markets.
Contact: Kit-Bacon Gressitt VP of Communications 800-843-7477 x 1143 760-522-1064
FFF Enterprises Inc.
CONTACT: Kit-Bacon Gressitt, VP of Communications of FFF Enterprises Inc.,+1-800-843-7477, ext. 1143, or +1-760-522-1064
