ZLB Behring, a global leader in the plasma protein biotherapeutics industry and subsidiary of CSL Ltd., has reached an agreement with MedImmune, Inc. to acquire CytoGam (cytomegalovirus immunoglobulin intravenous (human)) and related assets.
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 will acquire CytoGam for US $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. Immunoglobulins are indicated for the treatment of serious conditions including primary immune deficiency disorders and to prevent problems related to Rh factor in newborns.
"CytoGam fits well in ZLB Behring's immunoglobulin portfolio," said Peter Turner, president of ZLB Behring. "We are proud of our heritage of providing a reliable, quality supply of critical therapies to small patient populations. We look forward to continuing that heritage with transplant patients."
"We are pleased that CytoGam's role in meeting important medical needs associated with organ transplantation will continue to be met as part of ZLB Behring's portfolio of plasma-derived therapies," said David M. Mott, president and chief executive officer of MedImmune.
The acquisition includes CytoGam and related assets, including patents and trademarks, manufacturing contracts and government authorizations associated with the product. No employees will transfer to ZLB Behring from MedImmune.
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 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, osmotic nephrosis, 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, and wheezing were the most frequent adverse reactions observed during clinical trials.