CSL Behring Announces FDA Approval of Privigen™—First Proline-Stabilized 10 Percent Liquid IVIg

King of Prussia, PA—July 27, 2007—CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Privigen™ [Immune Globulin Intravenous (Human), 10% Liquid], an intravenous immunoglobulin (IVIg) for treating patients diagnosed with primary immunodeficiency (PI). Privigen™ is also indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) to rapidly raise platelet counts to prevent bleeding.

A 10 percent liquid preparation of polyvalent human immunoglobulin, Privigen™ offers healthcare professionals convenience and ease-of-use. It is the first and only proline stabilized IVIg that is always ready for immediate use, requiring no refrigeration orreconstitution.

“Privigen™ is an exciting new offering to patients and healthcare professionals in the United States,” said Paul Perreault, Executive Vice President of Worldwide Commercial Operations at CSL Behring. “As the leader in developing safe, high-quality, effective immune globulin therapies for use around the world, CSL Behring is proud to add yet another product to our rapidly growing portfolio. We see a strong demand for Privigen™ and are pleased to be bringing it to patients and other valued customers.”

“With Privigen™, once again, CSL Behring has answered an important need,” said Mark Stein, M.D., Chief, Allergy Section at Good Samaritan Hospital in West Palm Beach Hospital in Florida. “The time savings and flexibility it provides to healthcare professionals is an important step forward. It will certainly be a welcome addition to currently available immune globulin therapy options in the U.S.” Dr. Stein served as lead investigator on the Privigen™ clinical trial.

Privigen™ is indicated for the treatment of patients with primary immunodeficiency (PI) associated with defects in humoral immunity, including but not limited to common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. Privigen™ is also indicated to rapidly raise platelet counts to prevent bleeding in patients with chronic immune thrombocytopenic purpura (ITP).

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. The most serious adverse reactions in chronic ITP patients were aseptic meningitis syndrome in one subject and hemolysis in eight subjects.

Please see full prescribing information.