Omrix Biopharmaceuticals, Inc., a fully-integrated biopharmaceutical company that develops and markets protein-based biosurgery and passive immunotherapy products, announced that on July 3, 2007, the US Food and Drug Administration, or FDA, approved the company's use of Cryoprecipitate (cryo) from Talecris Biotherapeutics, Inc. (Talecris).
Cryo is a plasma fraction containing coagulation proteins and the raw material from which Omrix manufactures BAC, the fibrinogen component of its marketed fibrin sealants, Evicel and Quixil, and Fibrin Patch product candidate.
"We are happy to announce the achievement of this long-awaited milestone," stated Robert Taub, president and chief executive officer. "Utilizing cryo in our manufacturing process will allow Omrix to lessen its dependence on plasma and in the long-run, realize better gross margins."
The company anticipates that the receipt of the cryo approval will enable it to imminently ship substantial quantities of Evicel to Ethicon, a Johnson & Johnson company, of which the company had expected to ship approximately $1.0 million in the second quarter of 2007.
On October 11, 2006, Omrix announced a long term supply agreement with Talecris for cryo whereby Omrix committed to certain minimum purchases and obtained a right of first refusal to additional supply of cryo.
Omrix Biopharmaceuticals is a fully-integrated biopharmaceutical company developing and marketing protein-based biosurgery and passive immunotherapy products. Omrix' biosurgery product line includes products and product candidates that are used for the control of bleeding, or haemostasis, and other surgical applications.