Beriplex(R) P/N Provides Fast, Predictable and Safe Anti-coagulation Reversal, According to Study

GENEVA, July 10 /PRNewswire/ --

- Data presented at ISTH XXIst Congress show Beriplex P/N is 98 percent
effective in emergency bleeding situations

Beriplex(R) P/N, a human prothrombin complex concentrate (PCC), is highly
effective and safe in the emergency reversal of anti-coagulation according to
data presented today at the International Society on Thrombosis and
Haemostasis (ISTH) XXIst Congress. The data showed Beriplex P/N rapidly and
safely increases plasma levels of essential coagulation factors II, VII, IX,
and X and anticoagulant inhibitors Protein C and Protein S prior to emergency
interventions or to treat acute bleeding.

Anti-coagulation reversal (ACR) is used to correct the effects of oral
anticoagulants (such as warfarin) taken by patients to prevent and treat
thromboembolic disease. It may be required in preparation for elective or
emergency surgery or during an acute bleeding episode. Therapeutic options
currently available for ACR include Vitamin K for non-emergency situations
and human plasma, or PCCs, which are appropriate for urgent correction of
anticoagulation effects.

"The number of patients receiving long-term anticoagulant therapy is
growing, as is the need to quickly reverse the effects of these medications
in certain circumstances," said Dr. Ingrid Pabinger-Fasching, Department of
Internal Medicine I, Division of Hematology and Hemostaseology, University
Hospital Vienna, principal investigator of the study. "While multiple options
for anti-coagulation reversal exist when time is not an issue, our data show
that Beriplex P/N offers fast, complete, predictable and safe reversal of the
anticoagulation effect when urgency is required."

Today's Presentation: Study Design

Findings were based on a multi-national study that took place at 25
centres in eight countries. Enrolled in the prospective, open, uncontrolled
study were 43 patients aged 22 - 85 years (34 patients age >65 years, 79%)
who required emergency ACR due to either emergency intervention, such as
vascular or abdominal surgery (26 patients, 60%) or acute bleeds (17
patients, 40%). Almost all patients had multiple risk factors for developing
a thromboembolic event. With regard to dosing and infusion of Beriplex P/N,
median administration speed was 188 IU/min (range 50-1000), and median
infusion time was 12 minutes (range 3-50). Most patients simultaneously
received IV Vitamin K.

Key Findings

The primary endpoint of 30-minute post-infusion International Normalized
Ratio (INR) less than or equal to 1.3 was met. Factor recovery was >1 for all
coagulation factors administered with Beriplex P/N (Factor II, VII, IX and X
and thrombo-inhibitors Protein C and Protein S). Ninety-eight percent of
patients (42 patients) were assessed as having "very good" or "satisfactory"
response to therapy. The rapid reversal of anticoagulation provided
accelerated and effective control of hemorrhage. Further, all administrations
were well tolerated, and no virus transmission (HAV, HBV, HCV, HIV or Parvo
B19) was observed. Of six reported serious adverse events, five have been
confirmed to be unrelated to Beriplex P/N use; one event was reported
possibly related.

Phase I PK Study Confirms Rapid Control

In a separate Phase I pharmacokinetics study presented at the ISTH XXIst
Congress, Dr. Helmut Ostermann of University Hospital Munich and colleagues
found that Beriplex administered to 15 healthy volunteers induced a rapid
increase in plasma concentrations of coagulation factors II, VII, IX and X,
as well as anticoagulant proteins C and S. Maximum levels were reached within
5 minutes after infusion.

"These findings, together with the fact that Beriplex has a more rapid
preparation and administration time than other PCCs, indicate that Beriplex
is an excellent choice for patients requiring a rapid response time," said
Dr. Ostermann.

About Anti-coagulation Reversal (ACR)

Anti-coagulant reversal (ACR) is used to correct the effects of oral
anticoagulants taken by patients to prevent and treat thromboembolic disease.
It can be administered over time with various methods when urgency is not
required, such as when preparing for elective surgery. However, emergency ACR
may be required due to the need for urgent surgery or because a patient
experiences an acute bleed.

About Beriplex(R) P/N

Beriplex P/N is a plasma-derived prothrombin complex concentrate (PCC)
containing a number of important coagulation factors and anti-thrombotic
factors. Beriplex P/N may be used to urgently stop bleeding in patients on
oral anti-coagulants, urgently correct coagulation before major surgery, and
normalize coagulation in patients with liver disease where the respective
essential coagulation factors normally produced by the liver are missing or
insufficient. Beriplex P/N can be stored at room temperature and does not
require warming before administration. It reconstitutes quickly and has an
infusion speed of 8 ml/min. Beriplex P/N has been used in some countries for
more than a decade and its safety and efficacy have been evaluated in three
prospective clinical trials.

About CSL Behring

CSL Behring is a global leader in the plasma protein biotherapeutics
industry. Passionate about saving and improving the quality of patients'
lives, CSL Behring manufactures and markets a range of safe and effective
plasma-derived and recombinant products and related services. The company's
therapies are used in the treatment of rare diseases such as immune
deficiency disorders, hemophilia, von Willebrand disease, other bleeding
disorders and inherited emphysema. Other products are used for the prevention
of hemolytic diseases in the newborn, in cardiac surgery, organ
transplantation and in the treatment of burns. The company also operates one
of the world's largest plasma collection networks, ZLB Plasma. CSL Behring is
a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in
Melbourne, Australia. For more information, visit www.cslbehring.com.

Contacts:
    Sheila A. Burke, Director, Communications & Public Relations
    Worldwide Commercial Operations
    CSL Behring
    +1-610-878-4209
    Sheila.Burke@cslbehring.com

    - or -

    Jeff Hoyak
    MCS Public Relations
    +1-908-553-7212
    jeffh@mcspr.com

Web site:  http://www.cslbehring.com