Global SWIFT Studies Will Evaluate Safety and Efficacy of CSL Behring's Biostate(R) for von Willebrand Disease and Hemophilia A

By Csl Behring, PRNE
Wednesday, February 3, 2010

Global trial to develop Biostate announced at the 3rd Annual Congress of the European Association of Haemophilia and Allied Disorders

EDINBURGH, Scotland, February 4 - CSL Behring announced today the start of the global clinical trial
program SWIFT (Studies with von Willebrand factor [VWF]/Factor VIII) to
evaluate the pharmacokinetics, efficacy and safety of Biostate(R), a
low-volume, highly active, plasma-derived VWF/FVIII concentrate for the
treatment of von Willebrand disease (VWD) and hemophilia A. The methodology
behind the multi-center trials was detailed in a presentation at the 3rd
Annual Congress of the European Association of Haemophilia and Allied
Disorders (EAHAD) today.

"The management of patients with bleeding disorders like VWD and
hemophilia A continues to be challenging, and we welcome new therapeutic
options," said Professor Toshko Lissitchkov, M.D. of Specialized
Haematological Hospital Joan Pavel. "Our goal with the SWIFT program is to
evaluate the safety and efficacy of Biostate, a factor concentrate with high
specific activity that has the potential to benefit patients."

The SWIFT program, which will include centers in Europe, North America
and South America, comprises four open-label studies in adults/adolescents
and children with VWD and hemophilia A. CSL Behring is performing the SWIFT
studies to meet the regulatory requirements for making Biostate available in
multiple countries. Biostate has been available in Australia since 2003 where
it is indicated for the treatment of von Willebrand disease hemophilia A.

"CSL Behring has a heritage of innovation in developing bleeding disorder
therapies and making a difference in patients' lives," said Russell Basser,
M.D., Senior Vice President, Global Clinical Research, CSL Behring. "CSL
Behring's commitment to the hemophilia and von Willebrand disease community
will be further strengthened by Biostate's development and approval. It will
provide physicians and patients with another option in the management of
bleeding disorders, joining CSL Behring's Haemate(R) P/Humate-P(R) and other
therapies."

About the SWIFT Program

The SWIFT (Studies with von Willebrand factor [VWF]/Factor VIII) program
comprises four open-label, multicenter studies to evaluate the
pharmacokinetics, efficacy and safety of Biostate(R), a low-volume,
highly-active, VWF/FVIII concentrate for the treatment of von Willebrand
disease (VWD) and hemophilia A in both adult and pediatric patients. Patient
criteria for all four studies are as follows:

    - SWIFT-VWD will include patients at least 12 years of age diagnosed with
      von Willebrand disease (VWF: RCo less than 15 percent) and who require
      a VWF product to manage their VWD.

    - SWIFTLY-VWD will include pediatric patients (0-11 years of age) for
      whom treatment with a VWF replacement therapy is required for
      prophylactic therapy, hemostatic control during surgery or control of a
      non-surgical, spontaneous or traumatic bleeding event. Patients who are
      diagnosed with type 1, 2A or 3 VWD and a VWF: RCo level less than 15
      percent are eligible.

    - SWIFT-HA will include patients at least 12 years of age diagnosed with
      hemophilia A, including previously treated male patients with severe
      hemophilia (FVIII: C activity less than 1 percent).

    - SWIFTLY-HA will include pediatric patients with hemophilia A, including
      previously treated patients with severe hemophilia A (FVIII: C activity
      less than 1 percent).

About von Willebrand Disease

Von Willebrand disease is caused by a deficiency or abnormality of von
Willebrand factor (VWF), a protein in the blood that is necessary for normal
blood clotting. VWD is classified by types, ranging from Type 1 (the most
common and usually mild) to Type 3 (the most severe). Patients with Type 2
VWD have VWF that does not work properly, while patients with Type 1 or Type
3 do not have enough VWF to produce a normal clot. Women with VWD are more
likely to experience heavy, prolonged menstruation. Other common symptoms of
VWD include frequent nosebleeds and easy bruising. Bleeding can be mild or
serious and can occur as a result of injury, or without any obvious cause.
More serious symptoms include bleeding into joints and internal organs. VWD
patients may require special care during dental procedures, surgery and
childbirth.

About Hemophilia

Hemophilia 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.

About Biostate(R)

Biostate is a low-volume, highly active, plasma-derived VWF/FVIII
concentrate produced by a sophisticated manufacturing process that uses two
virus inactivation steps. Biostate contains high molecular weight multimers
of VWF. It has been shown that high molecular weight multimers are associated
with effective hemostasis and play a role in platelet adhesion, binding more
efficiently to platelets than do low molecular weight VWF multimers. Biostate
has a VWF:FVIII ratio of approximately 2.2:1. Biostate is not currently
licensed in Europe or the United States.

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 manufacturers 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 (ASX: CSL),
a biopharmaceutical company headquartered in Melbourne, Australia. For more
information, visit www.cslbehring.com.

Media Contacts:

    Sheila A. Burke, Director, Communications & Public Relations
    Worldwide Commercial Operations
    CSL Behring
    +1-610-878-4209 (o)
    +1-484-919-2618 (c)
    Sheila.Burke@cslbehring.com

    Brian Thompson
    MCS Healthcare Public Relations
    +1-908-234-9900 (o)
    +1-908-872-8024 (c)
    briant@mcspr.com

Sheila A. Burke, Director, Communications & Public Relations, Worldwide Commercial Operations, CSL Behring, +1-610-878-4209(o), +1-484-919-2618(c), Sheila.Burke at cslbehring.com; Brian Thompson, MCS Healthcare Public Relations, +1-908-234-9900(o), +1-908-872-8024(c), briant at mcspr.com

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