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CSL Behring Receives Orphan-Drug Exclusivity for RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency
Date:3/11/2009

taneous bleeding and bone, joint or tissue hemorrhage. Diminished concentrations of fibrinogen, also called Factor I (one), limit the body's ability to form a clot. Certain fibrinogen levels usually indicate normal blood clotting ability. To determine fibrinogen levels and confirm a diagnosis, blood coagulation testing is needed.

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

About RiaSTAP

RiaSTAP is a purified fibrinogen concentrate indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. RiaSTAP is not indicated for dysfibrinogenemia. RiaSTAP is contraindicated in individuals who have had severe immediate hypersensitivity reactions, including anaphylaxis to RiaSTAP or its components.

Physicians should monitor patients for early signs of allergic or hypersensitivity reactions and if necessary, discontinue administration and institute appropriate treatment. Thrombotic events have been reported in patients receiving RiaSTAP. Physicians should weigh the benefits of administration versus the risks of thrombosis.

RiaSTAP is made from pooled human plasma. Products made from human plasma may contain infectious agents (e.g., viruses and theoretically the Creutzfeldt-Jakob disease agent (CJD) that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by a process demonstrated to inactivate
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