CSL Behring Receives EU Orphan Drug Designations for rVIIa-FP for Hemophilia A and B Treatment

KING OF PRUSSIA, Pennsylvania, May 31, 2011 -

CSL Behring announced today that it has been granted Orphan Drug
Designations (ODD) by the European Commission for the development of its
recombinant fusion protein linking coagulation factor VIIa with albumin
(rVIIa-FP), a novel therapy to treat hemophilia A and hemophilia B patients
with inhibitors. The designations would entitle CSL Behring to exclusively
market recombinant factor VIIa fused with albumin in Europe for a period of
10 years if the product at the stage of license application fulfils the
orphan drug requirements. Based on the submission of data from the company's
Pediatric Investigation Plan, once available, the 10-year market exclusivity
may be extended to 12 years.

Under these designations European Medicines Agency (EMA) will also
provide CSL Behring with development assistance and with reductions in
certain regulatory fees.

"CSL Behring welcomes Orphan Drug Designation for rVIIa-FP as support of
our ongoing commitment to developing, manufacturing and marketing products
for the treatment of rare and serious diseases, such as hemophilia with
inhibitors," said Val Romberg, Senior Vice President, Global Research &
Development. "We will continue to work closely with the EMA to make this
important therapy available to patients as soon as possible."

An orphan drug designation application has not yet been submitted in the
United States.

By providing incentives to the pharmaceutical industry, the EU
legislative framework for orphan medicines encourages the development of
products intended to diagnose, prevent and treat life-threatening or
chronically-debilitating conditions that impact up to 5 in 10,000 people in
the European Union. The initiative helps improve access to quality medical
care for patients who have rare diseases for which there are few, if any,
approved treatments.

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. 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 frequent dosing.

Preclinical studies have confirmed that CSL Behring's rVIIa-FP has
favorable pharmacokinetic properties compared to the existing recombinant
product. A half-life extension of greater than 8-fold has been observed. The
use of a bypassing agent with an extended half-life could offer significant
benefit to those affected by hemophilia A or B with inhibitors and may offer
patients the opportunity to be treated less frequently than with the
currently available product.

CSL Behring's clinical program intends to demonstrate that an extended
half-life rVIIa-FP will result in a requirement for fewer doses while
providing adequate therapeutic response in patients with hemophilia A and B
with inhibitors.

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, hereditary angioedema
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.

    Contact:
    Sheila A. Burke, Director, Communications & Public Relations
    Worldwide Commercial Operations
    CSL Behring
    C: +1-484-919-2618
    O: +1-610-878-4209
    Sheila.Burke@cslbehring.com

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