First Export of Privigen® From New Manufacturing Facility in Broadmeadows, Melbourne, Australia

Turner Plant increases global market access of Immune Globulin Intravenous (Human), 10% Liquid Privigen®

Feb 23, 2016, 09:30 ET from CSL Behring

KING OF PRUSSIA, Pa., Feb. 23, 2016 /PRNewswire/ -- Global biotherapeutics leader CSL Behring today announced an increase in the global supply of Privigen® as the first export has been shipped from a new state-of-the-art manufacturing facility in Broadmeadows, Melbourne, Australia. The new Turner Privigen Facility, named for Mr. Peter J. Turner, former President of CSL Behring and former Chief Operating Officer of CSL group, will substantially increase CSL Behring's total immunoglobulin (Ig) therapy production capabilities. 

The inaugural shipment of Privigen, an intravenous Ig product used to treat primary immune deficiencies and immune thrombocytopenia purpura, to the United States in December 2015 was the culmination of a five-year construction and development project. This long-term strategic project was designed to address and meet future customer needs and reflects the strength of CSL Behring's global Ig business. 

"The increased capacity and manufacturing flexibility that the Turner plant adds fulfils our commitment to our patients with rare diseases, ensuring access to more product for more patients around the world", says Val Romberg, Executive Vice President, Manufacturing and Planning for CSL. He adds, "As a recognized leader in Ig therapeutics, we want to ensure that we can meet future demand as uses for Ig therapies expand."

Previously, Privigen was manufactured only in Bern, Switzerland, but is now also being manufactured at this new plant in Australia. Privigen manufactured at the Turner Facility will be made available in several countries including United States, Canada, Australia and New Zealand.

About Privigen®
Privigen is the first and only 10 percent, ready to use, room-temperature stored, liquid IVIG stabilized with proline, a naturally occurring amino-acid. In the United States, it is used as replacement therapy for patients with primary immunodeficiencies, and as an immunomodulatory therapy for patients with chronic immune thrombocytopenic purpura (ITP). It is available in over 70 countries around the world for treating these and other rare diseases.

For country specific indication information, visit:

Switzerland: http://www.compendium.ch/mpro/mnr/19716/html/de (German); http://www.compendium.ch/mpro/mnr/19716/html/fr (French)

Europe:  http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000831/human_med_000993.jsp&jsenabled=true

United States: http://www.privigen.com/Professional/Prescribing-Information.aspx

Canada: http://www.cslbehring.ca/docs/45/667/2015-07-08_183354_En_Privigen_PM_Approved.pdf

Australia: http://www.csl.com.au/s1/cs/auhq/1217017237558/Web_Product_C/1252900931292/ProductDetail.htm

Important Safety Information
Immune Globulin Intravenous (Human), 10% Liquid, Privigen®, is indicated as replacement therapy for 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 raise platelet counts in patients with chronic immune thrombocytopenic purpura (ITP).

WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE

  • Thrombosis may occur with immune globulin products, including Privigen. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. 
  • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of human immune globulin intravenous (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products that contain sucrose. Privigen does not contain sucrose.
  • For patients at risk of thrombosis, renal dysfunction or renal failure, administer Privigen at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

See full prescribing information for complete boxed warning.

Privigen is contraindicated in patients with history of anaphylactic or severe systemic reaction to human immune globulin, in patients with hyperprolinemia, and in IgA-deficient patients with antibodies to IgA, who have had hypersensitivity reactions. Patients with IgA deficiency and antibodies to IgA are at greater risk of severe hypersensitivity and anaphylactic reactions.

Privigen is derived from human plasma. The risk of transmission of infectious agents cannot be completely eliminated.

For full prescribing information for Privigen, including the boxed warning and the patient product information, visit http://www.privigen.com/professional/prescribing-information.aspx   

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

About CSL Behring
CSL Behring is a global biotherapeutics leader which is driven by its promise to save lives. Focused on serving patients' needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL), headquartered in Melbourne, Australia, employs more than 14,000 people with operations in more than 30 countries. For more information visit www.cslbehring.com and follow us on www.Twitter.com/CSLBehring.

Media Contact
Jennifer Purdue
Office: +1 (610) 878-4802
Mobile: +1 (610) 306-9355
Email: jennifer.purdue@cslbehring.com

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SOURCE CSL Behring



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