CSL Behring Presents Phase I Results From Study of Recombinant Fusion Protein Linking Coagulation Factor VIIa with Albumin

CSL Behring Presents Phase I Results From Study of Recombinant Fusion Protein
Linking Coagulation Factor VIIa with Albumin (rVIIa-FP) in Healthy Volunteers

Recombinant albumin fusion platform forms basis of innovation

PR Newswire

AMSTERDAM, July 3, 2013

AMSTERDAM, July 3, 2013 /PRNewswire/ --CSL Behring today presented Phase I
data of their recombinant fusion protein linking coagulation factor VIIa with
albumin (rVIIa-FP) in healthy volunteers at the International Society on
Thrombosis and Haemostasis (ISTH) congress in Amsterdam.

(Logo: http://photos.prnewswire.com/prnh/20130627/NY39350LOGO )

CSL Behring, in collaboration with its parent company, CSL Limited (ASX: CSL),
is developing rVIIa-FP, a novel therapy to treat hemophilia A and hemophilia B
patients who have inhibitors (antibodies that develop in response to treatment
with other clotting factors that prevents those treatments from working) as
part of the PROLONG 7- FP clinical study program. The objective of the
clinical program is 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.

"Our goal is to pioneer therapeutic solutions that address real unmet needs in
the hemophilia community," said Dr. Debra Bensen-Kennedy, Global Therapeutic
Head of Clinical Research and Development at CSL Behring. "With our
recombinant albumin fusion technology, we believe we have an innovative and
promising approach that may yield long-acting therapies with the potential to
truly advance hemophilia treatment."

About the Phase I study

The study enrolled a total of 40 healthy male volunteers between 18 and 35
years of age, who were dosed in five consecutive dose cohorts (140, 300, 500,
750 and 1000microgram /kg). In each cohort, six participants were randomized
to a single dose of rVIIa-FP and two to placebo. All participants received
anticoagulation with oral vitamin K antagonist to reach an international
normalized ratio (INR) between 2 and 3 prior to dosing with rVIIa-FP or

About rVIIa-FP

rFVIIa is an activated form of factor VII and can bypass the need for factor
VIII or IX in people with hemophilia who have developed inhibitors to clotting
factor concentrates to restore factor VIII or IX. Preclinical studies have
confirmed that CSL Behring's rVIIa-FP has favorable pharmacokinetic properties
compared with the existing recombinant FVIIa product. Significant increases in
half-life have been observed with CSL Behring's rVIIa-FP across all animal
species. 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.

About Hemophilia
Hemophilia is an inherited bleeding disorder characterized by prolonged or
spontaneous bleeding, especially into the muscles and joints. In nearly all
cases, it affects only males. 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 A affects
approximately 1 in 5,000 to 10,000 people. Hemophilia B is characterized by
deficient or defective factor IX. 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. The incidence of
inhibitors in individuals with hemophilia A is estimated to be 33 percent and
1 to 6 percent in patients with hemophilia B.

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 used around the world to treat coagulation disorders
including hemophilia and von Willebrand disease, primary immune deficiencies,
hereditary angioedema and inherited respiratory disease, and neurological
disorders in certain markets. The company's products are also used in cardiac
surgery, organ transplantation, burn treatment and to prevent hemolytic
diseases in the newborn. 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 http://www.cslbehring.com/.

Media Contact:
Sheila A. Burke, Director, Communications & Public Relations
Worldwide Commercial Operations
CSL Behring
610-878-4209 (o)
484-919-2618 (c)


Website: http://www.cslbehring.com
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