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CSL Behring Receives FDA Approval of RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency
Date:1/16/2009

that does not function as needed.

Symptoms of congenital fibrinogen deficiency include excessive bleeding following injury, bruising, bleeding of the umbilical cord at birth and from the site of the umbilical stump in a newborn, spontaneous bleeding and bone, joint or tissue hemorrhage. To determine fibrinogen levels and confirm a diagnosis, blood coagulation testing is needed.

"RiaSTAP marks a significant improvement in the treatment of congenital fibrinogen deficiency," said Dr. Marilyn Manco-Johnson, Professor of Pediatrics and Director, Mountain States Regional Hemophilia and Thrombosis Center. "Now patients with this rare bleeding disorder have access to an effective, safe and convenient therapy that has been available in Europe for years. CSL Behring's development of RiaSTAP for the U.S. market exemplifies the company's dedication to and support of the rare bleeding disorder community."

RiaSTAP is a purified fibrinogen concentrate that undergoes virus inactivation and removal for safety assurance. There have been more than 1 million units sold worldwide (marketed outside the U.S. under the trade name Haemocomplettan(R) P).

Results from the 15-patient PK study showed that median fibrinogen plasma antigen levels and median fibrinogen plasma activity levels reached a maximum within 30 minutes (antigen) to 1 hour (activity) post-infusion and decreased continuously afterward. Results also demonstrated a highly significant (p<0.0001) mean improvement in MCF from baseline to 1 hour post-infusion following RiaSTAP treatment.

CSL Behring is studying RiaSTAP in an ongoing post-marketing commitment study to further demonstrate safety and hemostatic efficacy.

"Safety at the Source"

CSL Behring owns and operates more than 70 plasma collection centers in the U.S. and Europe, applying high standards to the collection process. Before qualifying as a donor,
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SOURCE CSL Behring
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