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CSL Behring Receives EU Orphan Drug Designations for rVIIa-FP for Hemophilia A and B Treatment
Date:5/31/2011

ilia is an inherited bleeding disorder characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. The disease is caused by deficient or defective blood coagulation proteins known as factor VIII or IX. The most common form of the disease is hemophilia A, or classic hemophilia, in which the clotting factor VIII is either deficient or defective. Hemophilia B is characterized by deficient or defective factor IX. Hemophilia A affects approximately 1 in 5,000 to 10,000 people. Hemophilia B affects approximately 1 in 25,000 to 50,000 people. The recommended treatment for patients who are factor deficient is to treat by replacement factor therapy.

Some patients develop inhibitors, factor VIII or IX neutralizing antibodies which render further replacement therapy ineffective. It has been reported that up to 33% of all severe hemophilia A and up to 6% of all severe hemophilia B patients develop inhibitors.

Patients who have become refractory to replacement factor therapy can be treated with recombinant human factor VIIa. Factor VIIa is an enzyme that can both initiate blood clotting and, at high dose, "bypass" the factor VIII and IX dependent steps involved in effective coagulation. With the current commercially available recombinant product, frequent injections are needed to adequately control or prevent bleeding due to its inherent short half-life.

About the recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP)

Using a proprietary genetic fusion technology (patents pending), CSL Behring is in the pre-clinical phase of developing a novel fusion protein formed by linking recombinant Factor VIIa with albumin. Because albumin is the most abundant natural protein in plasma and has a very long half-life (i.e., more than 20 days), the CSL Behring fusion protein is expected to exhibit a good tolerability profile and improved pharmacokinetics that may allow for less freq
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SOURCE CSL Behring
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