L-Proline Stabilized Immune Globulin Intravenous (Human) 10% Liquid, Privigen™, Demonstrates Good Tolerability at High Infusion Rates

Bern, Switzerland — 17 March 2008

CSL Behring announced data today from a study that demonstrates its new liquid immune globulin intravenous (human) 10% product (Privigen™), is well-tolerated in patients with Primary Immune Deficiencies (PI); a group of predominantly genetic disorders that cause a malfunction in part or all of the immune system. New data from an additional study also showed that Privigen is well-tolerated when administered at high infusion rates. Both studies were presented at the American Academy of Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia, U.S.

The extension study aimed to assess the tolerability and safety of Privigen when administered at infusion rates higher than those of the pivotal study (12 mg/kg/min, as opposed to 8 mg/kg/min). Results showed that Privigen is well-tolerated at high infusion rates with no temporally associated adverse events requiring an infusion rate reduction or termination during the study. This higher infusion rate may translate into less time spent in the hospitals for patients.

Professor J.A. Church from Children’s Hospital Los Angeles, said, "These results are good news for patients with primary immune deficiency disorders. Privigen provides a clinically proven combination of efficacy, tolerability and ease of administration that reduces the burden of this life-long therapy."

The pivotal study aimed to assess the safety and efficacy in patients with PI. Privigen met all pre-defined efficacy and safety endpoints. The acute serious bacterial infections rate was 0.08, far less than one per patient year set by the U.S. Food and Drug Administration (FDA), and the proportion of infusions with temporally associated adverse events was 0.21, below the 0.4 FDA limit. During the 12 month treatment duration, the majority (86%) of the infusions (1,038) were administered at the highest rate permitted by the protocol (8 mg/kg/min), further demonstrating Privigen’s tolerability at higher infusion rates.

IVIgs are used to treat several conditions, including immunodeficiencies and autoimmune diseases. IVIg solutions are often formulated with glycine, but such solutions are not stable for extended time at room temperature. The use of L-proline (250 mmol/L) at pH 4.8 has recently been demonstrated to allow storage of Privigen at room temperature during its entire shelf life.

In July 2007, the U.S. Food and Drug Administration (FDA) granted marketing approval to CSL Behring for Privigen, an intravenous immunoglobulin (IVIg), for treating patients diagnosed with primary immunodeficiency (PI) and immune thrombocytopenic purpura (ITP). In January 2008, Health Canada granted the Notice of Compliance for Privigen. CSL Behring recently launched Privigen. An application is currently under review by European and Swiss Regulatory Authorities for licensing in certain European countries.

Important Safety Information
WARNING: Renal dysfunction, acute renal failure, osmotic nephrosis, and death may be associated with the administration of Immune Globulin Intravenous (Human) (IVIg) products in predisposed patients. Administer IVIg products at the minimum infusion rate possible. Renal dysfunction and acute renal failure occur more commonly in patients receiving IVIg products containing sucrose. Privigen does not contain sucrose. See full prescribing information for complete boxed warning.

Privigen is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin, in patients with hyperprolinemia, and in patients with selective IgA deficiency.

In patients at risk for developing renal failure, monitor urine output and renal function, including blood urea nitrogen and serum creatinine. Also monitor patients with risk factors for thrombotic events, including a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, hypercoagulable disorders, prolonged periods of immobilization, and/or known or suspected hyperviscosity.

Aseptic meningitis syndrome (AMS) has been reported infrequently with Privigen and other IVIg treatments; AMS may occur more frequently with high doses and/or rapid infusion of IVIg. Hemolysis, hemolytic anemia, and pulmonary adverse events have also been reported. If transfusion-related acute lung injury is suspected, test product and patient for antineutrophil antibodies.

Privigen is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

In clinical studies, the most common adverse reactions with Privigen were headache, pain, nausea, pyrexia/ hyperthermia, fatigue, chills, and anemia.

For more details and complete prescribing information on Privigen please call the CSL Behring Medical Information Department in the U.S. at 1-800-504-5434.

About Primary Immune Deficiencies
These are a group of predominantly genetic disorders that cause a malfunction in part or all of the immune system, keeping the patient from fighting off infections caused by everyday germs. For individuals with PI – many of them children – infections may not improve with treatment as expected, and may keep returning. As a result, patients may face repeated rounds of antibiotics or be hospitalized for treatment. Repeated infections can lead to organ damage, which, over time, can become life-threatening. In some severe cases of PI, infections may result in a patient being hospitalized repeatedly. Some infections, such as meningitis, may even result in death. Nearly 100 types of PIs exist. Most are inherited, but in some cases the cause is unknown.

No single treatment works for all of the different types of PI. Infusions of replacement antibodies (immune globulins or Ig) can help supplement the immune system to prevent infection in nearly three-quarters of those people living with PI whose disease is tied to an antibody deficiency.

About CSL Behring
CSL Behring is a global leader in the plasma protein biotherapeutics industry. Passionate about improving the quality of patients' lives, CSL Behring manufactures and markets a range of safe and effective plasma-derived and recombinant products and related services. The company's therapies are used in the treatment of immune deficiency disorders, hemophilia, von Willebrand disease, other bleeding disorders and inherited emphysema. Other products are used for the prevention of hemolytic disease in newborns, in cardiac surgery, organ transplantation and in the treatment of burns. The company also operates one of the world's largest plasma collection networks, ZLB Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit

Media Contacts:
Therese Hilfiker, Director Communications & Training
CSL Behring AG
Wankdorfstr. 10, 3000 Bern 22, Switzerland
+41 31 344 44 44

Natalie Murphy
Weber Shandwick
+44 207 067 0331

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