Helixate FS Receives FDA Approval for Routine Prophylaxis in Children with Hemophilia A

KING OF PRUSSIA, Pa.--(Business Wire)--
CSL Behring announced today that Helixate® FS, Antihemophilic Factor
(Recombinant), has been approved by the U.S. Food and Drug Administration (FDA)
for routine prophylaxis in children with hemophilia A who are 16 years old or
younger and do not have pre-existing joint damage. This new indication was
granted by the FDA after determining Helixate FS is safe and effective for
routine prophylaxis, which can reduce the frequency of bleeding episodes and the
risk of joint damage in children with hemophilia A.

"The FDA`s approval of this additional indication for Helixate FS will
significantly benefit the bleeding disorders community," said Garrett E.
Bergman, M.D. Senior Director of Medical Affairs, U.S. Commercial Operations at
CSL Behring. "Prophylactic treatment will reduce the frequency of bleeding
episodes in children with hemophilia A which, over time, will help prevent
additional joint damage caused by bleeds."

"Bleeding into joints, including the ankles, elbows and knees, is a concern for
children with hemophilia A and their treatment providers," said Jerry S. Powell,
M.D., Director of the Hemophilia Treatment Center at the University of
California, Davis. "The FDA's approval of Helixate FS for routine prophylaxis is
an innovation that will help our patient population effectively manage their
condition. Modern treatment of hemophilia means preventing bleeding through
routine prophylaxis, and we eagerly anticipate our patients reaching young
adulthood with minimal joint damage and the ability to pursue normal lives."

With more than 2.5 billion units infused to date, Helixate FS has been shown to
be safe and effective in clinical studies as well as in post marketing use in
the hemophilia community. For more information about Helixate FS, please visit
www.HelixateFS.com or call CSL Behring Consumer Affairs at 1-888-508-6978.

About Hemophilia

Hemophilia is an inherited bleeding disorder characterized by prolonged or
spontaneous bleeding, especially into the muscles, joints, or internal organs.
About 15,000 Americans have hemophilia. The disease is caused by deficient or
defective blood coagulation proteins known as factor VIII or factor IX. The most
common form of the disease is hemophilia A, or classical hemophilia, in which
the clotting factor VIII is either deficient or defective. Hemophilia B is
characterized by deficient or defective factor IX.

About Helixate FS

Helixate FS is a recombinant factor VIII product indicated to control and
prevent bleeding episodes in adults and children with hemophilia A. Helixate FS
is also indicated for routine prophylaxis to reduce the frequency of bleeding
episodes and the risk of joint damage in children with hemophilia A with no
preexisting joint damage.

The most serious adverse reactions with Helixate FS are systemic
hypersensitivity reactions and the development of high-titer inhibitors
necessitating alternative treatments to antihemophilic factor. The most common
adverse reactions observed in clinical trials were inhibitor formation in
previously untreated or minimally treated patients, skin-associated
hypersensitivity reactions, infusion site reactions, and central venous access
device (CVAD) line-associated infections.

Helixate FS is contraindicated in patients who have manifested life-threatening
immediate hypersensitivity reactions, including anaphylaxis, to the product or
its components, including mouse or hamster proteins.

Helixate FS offers convenient administration with a 2.5-mL volume diluent for
most assay sizes; no available factor VIII product has a smaller diluent size.
No albumin is used in the formulation or purification of Helixate FS, and its
manufacture includes a solvent/detergent viral inactivation step.

In 2006, the FDA gave approval for Helixate FS to be stored at room temperature
(up to 25°C, 77°F) for three months. The storage guidelines for the hemophilia
treatment provide users with greater flexibility and simplify storage options.

Please visit www.helixatefs.com/prescribinginformation.aspx for full prescribing
information.

Helixate® FS is manufactured by Bayer HealthCare LLC for CSL Behring LLC.

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 manufactures 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.

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

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