FORT LEE, N.J., July 31, 2012 /PRNewswire/ -- Effective today, The Kedrion Group [www.kedrion.com] completed acquisition of the RhoGAM® line of products [www.RhoGAM.com] from Ortho-Clinical Diagnostics, Inc. (OCD). 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, Inc., a wholly owned subsidiary of Ortho Clinical Diagnostics that is a U.S. FDA-licensed donation center located in Williamsville, N.Y. that has collected blood plasma from the unique donor population used in the manufacturing process of the RhoGAM® Brand for over 30 years.
Prior to the development of RhoGAM® Brand, it is estimated that more than two dozen babies in the U.S. were lost daily due to the devastating effects of hemolytic disease of the newborn (HDN). Today, HDN has been virtually eliminated in most developed countries, although the risk of anti-D sensitization is still a problem in several developing countries where prenatal care is suboptimal.
"Our primary focus is to ensure that the tens of thousands of obstetricians and gynecologists, nurses, midwives, blood bankers and Rh-negative women who need it will continue to have this critical product as well as the service and education all have come to associate with this legacy brand," said Paolo Marcucci, Chief Executive Officer of Kedrion Biopharma, a U.S. subsidiary of the Kedrion Group. "Ortho Clinical Diagnostics will work with Kedrion to ensure a smooth transition so there are no changes in access to these life-saving products and services," he added.
Developed in the U.S. and manufactured and distributed by OCD for over 40 years, RhoGAM® Brand was the first and is still the most prescribed Rho(D) immune globulin brand for the prevention of Rh hemolytic disease of the newborn (HDN).
"Acquisition of RhoGAM® Brand, the legacy anti-D immune globulin, complements our portfolio of high-quality plasma-derived products, including those for the treatment of the hemolytic disease of the newborn, hemophilia and immune deficiencies," said Marcucci.
History of the RhoGAM® Brand In the past, women with Rh-negative blood experienced the heartbreak of mysteriously losing baby after baby for no apparent reason. Many of these women gave birth to a healthy first child, only to experience subsequent pregnancies that ended in miscarriage, stillbirth or birth to babies with anemia, jaundice or other serious health problems. In the early 1940s, two scientists discovered the presence of the Rh factor in the blood. Over the next 25 years, scientists from around the world searched for a treatment to prevent the expectant mother's blood from being sensitized by the Rh factor.
In 1966, researchers at the Ortho Research Foundation reported the first successful prevention of maternal sensitization to the Rh factor after administering an anti-Rho(D) preparation following delivery. On May 29, 1968 the first dose of RhoGAM® Brand was administered to a new mother at a hospital in Teaneck, N.J., who safely gave birth to two more healthy children a few years later.
How RhoGAM® Brand Protects Against HDN RhoGAM® Ultra-Filtered PLUS is a sterile solution that contains antibodies to the Rh factor. The antibodies in RhoGAM® Brand are derived from human plasma that has been carefully screened and processed for purity. When injected around 28 weeks of pregnancy, the RhoGAM® Brand antibodies circulate in the Rh-negative mother's bloodstream and prevent her immune system from making the sensitized antibodies that would threaten a baby with Rh-positive blood. A second dose for added protection will be administered within 72 hours of delivery if the infant is found to be Rh-positive. Rh-negative women need to receive RhoGAM® Brand during each pregnancy to prevent sensitization of their blood.
Important Safety Information RhoGAM® and MICRhoGAM® Ultra-Filtered PLUS Rh(D) Immune Globulin (Human) are made from human plasma. Since all plasma-derived products are made from human blood, they may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent. RhoGAM® and MICRhoGAM® are intended for maternal administration. Do not inject the newborn infant. Local adverse reactions may include redness, swelling, and mild pain at the site of injection and a small number of patients have noted a slight elevation in temperature. Patients should be observed for at least 20 minutes after administration. Hypersensitivity reactions include hives, generalized urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. RhoGAM® and MICRhoGAM® contain a small quantity of IgA and physicians must weigh the benefit against the potential risks of hypersensitivity reactions. Patients who receive RhoGAM® and MICRhoGAM® for Rh-incompatible transfusion should be monitored by clinical and laboratory means due to the risk of a hemolytic reaction.
About The Kedrion Group Headquartered in the province of Lucca, Italy, the Kedrion Group researches, develops, manufactures and distributes plasma derived products, including those for the treatment of hemolytic disease of the newborn, hemophilia and immune deficiencies. In 1999, the company established its first U.S. subsidiary, Haemopharm Inc. and, in 2011, established Kedrion Biopharma to market and distribute in the U.S. its human antihemophilic factor Koate®-DVI; Albuked®, Albumin (Human), and Kedbumin™, Albumin (Human), both sterile preparations of albumin protein in an aqueous solution administered intravenously; and Gammaked™, an intravenous immune globulin for the treatment of immune disorders. In the U.S., Kedrion also owns a plasma-fractionation plant in Melville, NY and, with the acquisition of Somerset Labs, owns nine (9) operating centers managed by KEDPlasma United States. Outside the U.S., Kedrion owns three (3) plasma centers in Germany.
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SOURCE The Kedrion Group