ZLB Behring Completes Purchase of CytoGam(R) Immunoglobulin Therapy From MedImmune.KING OF PRUSSIA King of Prussia, industrialized suburban area (1990 pop. 18,406), Montgomery co., SE Pa. It has glass and steel fabricating, food processing, printing and publishing, and varied manufacturing (textiles, liquified petroleum gas, water-treatment and electrical , Pa. -- ZLB Behring, a global leader in the plasma protein biotherapeutics industry and subsidiary of CSL Ltd. (ASX ASX See: Australian Stock Exchange : CSL), today announced it has completed its purchase of CytoGam[R] (cytomegalovirus immunoglobulin intravenous (human)) and related assets from MedImmune, Inc. CytoGam is an intravenous immunoglobulin enriched in antibodies against cytomegalovirus (CMV), which is indicated for preventing CMV disease associated with transplantation of the kidney, lung, liver, pancreas and heart. CMV is the most common cause of life-threatening infection occurring in solid organ transplants. ZLB Behring paid U.S. $120 million in cash, $70 million of which is subject to achievement of sales milestones. ZLB Behring manufactures immunoglobulins and other plasma-derived therapies, and markets them in more than 100 countries. The acquisition includes CytoGam and related assets, including trademarks, manufacturing contracts and government authorizations associated with the product. About CytoGam CytoGam is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart. In transplants of these organs other than kidney from CMV seropositive donors into seronegative seronegative /se·ro·neg·a·tive/ (-neg´ah-tiv) showing negative results on serological examination; showing a lack of antibody. se·ro·neg·a·tive adj. recipients, prophylactic CMV-IVIg should be considered in combination with ganciclovir. CytoGam is made from human plasma and, like other plasma products, carries the possibility for transmission of blood-borne viral agents. CytoGam should not be used in individuals with a history of a prior severe reaction to CytoGam or other human immunoglobulins. Immunoglobulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure acute renal failure Acute kidney failure Nephrology An abrupt decline in renal function, triggered by various processes–eg, sepsis, shock, trauma, kidney stones, drug toxicity-aspirin, lithium, substances of abuse, toxins, iodinated radiocontrast. , osmotic nephrosis nephrosis (nəfrō`səs), kidney disease characterized by lesions of the epithelial lining of the renal tubules, resulting in marked disturbance in the filtration function and the consequent appearance of large amounts of protein (albumin) , and death. CytoGam contains sucrose as a stabilizer. In patients predisposed to acute renal failure, IVIg products should be administered at the minimum concentrations available and the minimum rate of infusion practical. Severe reactions such as angioneurotic edema and anaphylactic shock, although not observed during clinical trials, are a possibility. Minor reactions such as flushing, chills, muscle cramps, back pain, fever, nausea, vomiting, arthralgia arthralgia /ar·thral·gia/ (ahr-thral´jah) pain in a joint. ar·thral·gia n. Severe pain in a joint. Also called arthrodynia. , and wheezing Wheezing Definition Wheezing is a high-pitched whistling sound associated with labored breathing. Description Wheezing occurs when a child or adult tries to breathe deeply through air passages that are narrowed or filled with mucus as a were the most frequent adverse reactions observed during clinical trials. For more information, please download a package insert at http://www.zlbbehring.com/docs/666/202/cytogam_pi.pdf About ZLB Behring ZLB Behring is a global leader in the plasma protein biotherapeutics industry. Dedicated to improving the quality of life for patients throughout the world, ZLB Behring provides safe and effective plasma-derived and recombinant products and offers patients a wide range of related services. The company's broad portfolio of life-saving therapeutics is used in the treatment of individuals with hemophilia, von Willebrand Disease Von Willebrand Disease Definition Von Willebrand disease is caused by a deficiency or an abnormality in a protein called von Willebrand factor and is characterized by prolonged bleeding. and other bleeding disorders, immune deficiency disorders, and inherited emphysema; for the prevention of hemolytic he·mo·lyt·ic adj. Destructive to red blood cells; hematolytic. Hemolytic Referring to the destruction of the cell membranes of red blood cells, resulting in the release of hemoglobin from the damaged cell. diseases for the newborn; in cardiac surgery patients; and in shock and burn victims. Additionally, ZLB Behring operates one of the world's largest, fully owned plasma collection networks. ZLB Behring is a subsidiary of CSL Limited, a biopharmaceutical company, which operates worldwide from its headquarters in Melbourne, Australia. For more information, please visit www.ZLBBehring.com. |
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