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CSL Behring Receives FDA Approval to Extend Shelf Life for Privigen from 24 to 36 Months

KING OF PRUSSIA, Pa., April 19 /PRNewswire/ -- CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to extend the shelf life for Privigen, Immune Globulin Intravenous (Human), 10% Liquid, from 24 to 36 months. The approval makes Privigen the first liquid intravenous immunoglobulin (IVIg) in the U.S. that can be stored at room temperature throughout its entire 36-month shelf life.

Privigen is the first and only 10 percent liquid IVIg stabilized with proline, a naturally occurring amino-acid. The product is indicated for primary immunodeficiency (PI), a group of disorders, usually genetic, that result from a malfunction in part or all of the immune system. This condition prevents patients from fighting off infections caused by everyday germs. Privigen is also indicated for the treatment of patients with chronic immune thrombocytopenic purpura (ITP) to raise platelet counts.

Proline efficiently minimizes dimer formation (less than or equal to 12% dimers) and allows storage of Privigen at room temperature (up to 25 degrees C [77 degrees F]) throughout its entire 36-month shelf life. Because the product does not need refrigeration, Privigen is always ready for immediate use. As a liquid IVIg, it also requires no reconstitution, which saves preparation time and minimizes product waste.

"CSL Behring has a history of developing innovative immunoglobulin therapies and we continually strive to enhance the quality of the life-saving products our patients depend on," said Robert Lefebvre, Vice President and General Manager, U.S. Commercial Operations at CSL Behring. "Part of that commitment includes convenience for patients and health providers. The approval of an extended shelf life for Privigen is another example of our dedication to meeting customer needs."

The sBLA for Privigen was based on a three-year study assessing the product's stability. Physicochemical, biological and immunological parameters were assessed during 36 months' storage under controlled conditions at 25 degrees C (77 degrees F). Over the 36 months, the IgG fraction in Privigen maintained high purity (greater than or equal to 98%) and no relevant amounts of aggregated IgG molecules were formed. Also, the use of proline at pH 4.8 inhibited dimer formation (less than or equal to 12%) throughout the study period.

Privigen is part of the Ig franchise of CSL Behring. This comprehensive immunoglobulin product portfolio also includes the first 16 percent and first 20 percent subcutaneous immunoglobulin (SCIg) therapies approved in the U.S. by the FDA. CSL Behring manufactures Privigen at its state-of-the art facility in Bern, Switzerland where the most advanced technologies are applied to ensure product safety and ample supply. This facility represents the long-term commitment of CSL Behring to global Ig markets.

For more information about Privigen, including full prescribing information, visit http://www.privigen.com/privigen-pi-privigen-prescribing-information.aspx.

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 IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.

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) may occur infrequently with Privigen and other IVIg treatments, and 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. 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 for Privigen, please call the CSL Behring Medical Information Department at 1-800-504-5434.

About Primary Immunodeficiencies

Nearly 100 types of PIs exist. For individuals with PI, many of them children, infections may not improve as expected with usual treatments and may keep returning. As a result, patients may face repeated rounds of antibiotics or hospitalization for treatment. Repeated infections can lead to organ damage, which over time can become life-threatening. Some infections, such as meningitis, may even result in death.

Collectively, PIs affect an estimated 10 million people worldwide, and the incidence is estimated to be 1 in 10,000. Due to the X-linked inheritance in many PI syndromes, more males are affected than females. For more information on PI, please visit www.cslbehring.com or contact the leading PI patient advocate groups in the U.S., the Immune Deficiency Foundation and the Jeffrey Modell Foundation.

About ITP

Immune Thrombocytopenic Purpura, or ITP, is an autoimmune disease in which the immune system attacks and destroys the body's own platelets, the cells that prevent bleeding in blood vessels and facilitate clotting. There are two forms of ITP: acute ITP, which resolves within six months, and chronic ITP, which most often occurs in adults and by definition lasts six months or longer. The annual incidence of ITP is 100 to 115 in every one million people. In the U.S., approximately 200,000 people have the disorder.

ITP is characterized by a low number of platelets (<30 x 109/L), usually caused by the body's production of substances (antibodies) that coat the platelets and signal their elimination from the blood. Diagnosis of ITP is often made by excluding other possible causes of the low platelet count and bleeding. People with the disorder often have purple bruises on the skin called purpura, a sign that bleeding has occurred in small blood vessels under the skin. They can also have petechiae, small red splotches on the skin that resemble a rash.

About CSL Behring

CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufacturers and markets a range of plasma-derived and recombinant therapies worldwide. CSL Behring therapies are indicated for the treatment of coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies and inherited respiratory disease. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in newborns. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited , a biopharmaceutical company headquartered in Melbourne, Australia. For more information, visit www.cslbehring.com.

Source: CSL Behring

CONTACT: Greg Healy, Senior Manager, Communications & Public Relations, U.S. Commercial Operations, CSL Behring, +1-610-878-4841, Greg.Healy@cslbehring.com

Web Site: http://www.cslbehring.com/

Posted: April 2010

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