The Kedrion Group has completed its acquisition of the RhoGAM line of products from Ortho-Clinical Diagnostics (OCD), a Johnson & Johnson company. The acquisition includes the transfer of the Rho(D) Immune Globulin (Human) RhoGAM Ultra-Filtered Plus and Rho(D) Immune Globulin (Human) MICRhoGAM Ultra-Filtered Plus products, as well as Somerset Laboratories, a subsidiary of OCD. The deal will aim to complement Kedrion's portfolio of plasma-derived products, including those for the treatment of the haemolytic disease of the newborn, haemophilia and immune deficiencies.
Developed in the US and manufactured and distributed by OCD, RhoGAM is prescribed Rho(D) immune globulin for the prevention of Rh haemolytic disease of the newborn (HDN). Prior to the development of RhoGAM, it is estimated that more than two dozen babies in the US were lost daily due to the effects of haemolytic disease of the newborn (HDN). Now, HDN has been virtually eliminated in most developed countries, although the risk of anti-D sensitisation is still a problem in several developing countries where prenatal care is suboptimal.
RhoGAM Ultra-Filtered Plus is a sterile solution that contains antibodies to the Rh factor. The antibodies are derived from human plasma that has been screened and processed for purity. When injected around 28 weeks of pregnancy, the RhoGAM antibodies circulate in the Rh-negative mother's bloodstream and prevent her immune system from making the sensitised antibodies that would threaten a baby with Rh-positive blood. A second dose for added protection is administered within 72 hours of delivery if the infant is found to be Rh-positive. Rh-negative women need to receive RhoGAM during each pregnancy to prevent sensitisation of their blood.