Manufacturing Deals Signed for Pathogen-Free Plasma
Cerus has put in place separate agreements that will see Blood Systems and the American Red Cross manufacture its Intercept plasma for use in the transfusion of thrombotic thrombocytopenic purpura (TTP) patients, once the product has been approved by FDA. Intercept plasma utilizes Cerus’ Helinx technology for inactivating pathogens or white blood cells that may be present in blood components.
The Intercept Blood Systems for both platelets and plasma are already marketed in Europe and other markets, and Cerus is currently in discussions with FDA to determine the requirements for approval for the TTP indication in the U.S. An Intercept red blood cell system is currently in clinical development.
Under terms of the two new agreements, if Intercept plasma is approved by FDA, the American Red Cross and Blood Systems would manufacture the product for the treatment of TTP in the U.S., facilitating controlled distribution of the treated plasma to blood centers and hospitals supporting the TTP population. Cerus would provide the Intercept kits to the Red Cross and Blood Systems, and recoup kit price from the final sale of the Intercept plasma products. Collection and preparation of the plasma would be performed by the two blood organizations.
"The Red Cross and Blood Systems are two of the world’s preeminent blood centers, together producing approximately 60% of the U.S. blood supply," comments William Greenman, Cerus president and CEO. "With the support of these two great partners in addition to this new business model for commercializing Intercept-treated blood components, we believe that we are well-positioned for a successful U.S. launch pending FDA approval of the Intercept plasma system."