-Company Joins Supplier Base Offering Broad Array of Healthcare Products to
Patients with Immune Deficiency and Bleeding Disorders
OTTAWA, April 3, 2008 /PRNewswire/ — CSL Behring Canada, Inc. today
announced that Canadian Blood Services, and Hema-Quebec, have each awarded
the company contracts to supply Helixate(R) FS (Antihemophilic Factor
[Recombinant]), Humate(R) P (Antihemophilic factor / von Willebrand Factor
Complex [Human], Dried, Pasteurized), Privigen (Immune Globulin Intravenous
[Human]), Vivaglobin(R) (Immune Globulin Subcutaneous [Human]) and other
plasma-derived products. These products are used for the treatment of
conditions such as hemophilia, von Willebrand Disease, primary
immunodeficiency as well as other serious conditions.
The contracts call for CSL Behring to supply the above mentioned
life-saving therapies over a period of at least five years, and to provide
toll manufacturing services to Canadian Blood Services for the
fractionation of Canadian plasma. In addition, with this agreement, CSL
Behring will become the main supplier of bleeding disorder treatments in
the province of Quebec.
CSL Behring currently maintains a portfolio of 23 different products,
which it develops, manufactures, and distributes to the global healthcare
community. The company also offers comprehensive consumer support, research
and education support, disease awareness campaigns and other initiatives to
ensure that patients receive proper diagnoses and treatment interventions.
“We at CSL Behring in Canada are quite pleased with the awards,” said
Dr. Heinz Neuhaus, General Manager of CSL Behring Canada. “Our company has
made significant investments in becoming a reliable partner for both
Canadian Blood Services and Hema-Quebec so that we can expand our product
offering to Canadian patients in need. It is gratifying to be recognized
with a supply agreement that allows us to strengthen even further our
commitment to saving and improving lives.”
“CSL Behring continues to grow and expand its capacity to develop,
manufacture, and supply a broad array of therapies around the world,” said
Paul Perreault, Executive Vice President of CSL Behring Worldwide
Commercial Operations. “Canada is an extremely important market for us, and
we look forward to delivering to Canadians the safe, effective,
high-quality medicines for which our company has become known.”
“One of Canadian Blood Services strategic directions for plasma protein
products is to broaden its supplier base for commercial products and
fractionation services,” said Dr. Graham Sher, Chief Executive Officer of
Canadian Blood Services. “This new partnership with CSL allows us to
successfully achieve this strategic objective.”
“With its long history of success in the biotherapies industry, CSL
Behring Canada has shown it can perform as a trustworthy partner,” said Dr.
Francine Decary, President and CEO of Hema-Quebec. “We look forward to
initiating what we expect to be a long and productive business relationship
with CSL Behring in the supply of important medicines to patients in
About Hemophilia A and von Willebrand Disease
Hemophilia is a bleeding disorder caused by a deficiency in one of the
blood clotting factors (Factor VIII). Hemophilia A (often called classic
hemophilia) accounts for about 80% of all hemophilia cases.
Hemophilia A is a hereditary disorder in which the clotting ability of
the blood is impaired and excessive bleeding results. Small wounds and
punctures are usually not a problem, but uncontrolled internal bleeding can
result in pain and swelling as well as permanent damage, especially to
joints and muscles.
The severity of symptoms can vary between individuals and the most
severe forms become apparent early on during a child’s development.
Prolonged bleeding is the hallmark of hemophilia A and is typically first
noticed when an infant is circumcised. Additional bleeding manifestations
make their appearance when the infant becomes mobile. Mild cases may go
unnoticed until later in life when there is excessive bleeding and clotting
problems following surgery or trauma. Internal bleeding may happen
anywhere, and bleeding into joints is common.
The incidence of hemophilia A is one in 10,000 live male births. Women
may also have it, but it is very rare. With treatment and management, the
outcome is good and the majority of patients suffering from hemophilia are
able to lead relatively normal lives.
Von Willebrand disease (VWD) is caused by a deficiency or abnormality
of the von Willebrand factor, a protein present in the blood which is
necessary for normal blood clotting.(i) Men and women are equally likely to
be affected by VWD.(i) VWD is classified by types, ranging from Type I (the
most common and mild) to Type III (the most severe).
According to the World Federation for Hemophilia, VWD is found in
approximately 1-2 percent of the world’s population, although that
prevalence is much higher in certain countries such as Iran.
Common symptoms of VWD include frequent nosebleeds and easy bruising.
It can be mild or serious and can occur as a result of injury, or without
any obvious cause.(i) More serious symptoms include bleeding into joints
and internal organs. Women with VWD are more likely to experience abundant,
Individuals with the more severe form of VWD should avoid unnecessary
trauma, such as those brought on by contact sports. Patients with VWD may
require special care during dental procedures, surgery and childbirth.(ii)
There is no “cure” for VWD, but it can be treated. Specific treatments may
include desmopressin acetate to release stored von Willebrand factor; von
Willebrand factor replacement therapies, such as Humate-P(R),
Antihemophilic Factor/von Willebrand Factor Complex (Human) Dried,
Pasteurized; and oral contraceptives to reduce menstrual bleeding and raise
von Willebrand factor in the bloodstream(ii).
About Helixate(R) FS and Humate-P(R)
Helixate(R) FS is a recombinant version of the human factor VIII
(FVIII) produced with the help of baby hamster kidney (BHK) cells. It is
used to treat hemophilia A when there is a demonstrated deficiency of the
above mentioned factor FVIII, a plasma clotting factor. Helixate(R) FS
should be administered cautiously in patients with previous
hypersensitivity to constituents of FVIII preparations or known sensitivity
to mouse or hamster protein.
Helixate(R) FS should not be used to treat people with VWD since it
does not contain the von Willebrand factor, the endogenous protein which is
absent or defective in the VWD. For more information about von Willebrand
disease, please visit http://www.allaboutbleeding.com.
Adverse events related to the use of Helixate (R) FS are generally
minor. The most common events include injection-site reactions, dizziness
Humate-P(R) is a stable, purified, sterile, lyophilized concentrate of
Antihemophilic Factor (Human) and von Willebrand Factor (vWF) (Human)
complex used for the treatment of patients with classical hemophilia
(hemophilia A) and VWD.
Humate-P(R) is usually tolerated without reaction. It should be
administered with caution to patients with a known allergic reaction to
constituents of the preparation. Cases of allergic reactions and rise in
body temperature have been observed. Anaphylactic reactions can occur in
rare instances. Thromboembolic events have been reported in VWD patients
receiving coagulation factor replacement, especially in the setting of
known risk factors for thrombosis. Caution should be exercised and
antithrombotic measures considered.
Humate-P(R) is made from human plasma and there is a theoretical risk
that it may contain pathogens susceptible to cause diseases such as the
hepatitis viruses, HIV and, in theory, the agent responsible for the
In some cases, patients may develop inhibitors of Factor VIII. These
correspond to a patient’s own antibodies which are directed against the
Factor VIII present in Helixate(R) FS or Humate-P(R).
For more information about Helixate(R) FS and Humate-P, please contact:
CSL Behring Canada, 1-866-773-7721.
About Immune Deficiency Disorders
Primary Immune Deficiencies (PIDs) are a group of disorders, usually
genetic in nature, that cause a malfunction of the immune system, either in
part or in totality, thus preventing the patient from fighting off
infections caused by everyday microorganisms. For individuals with PID –
many of them children – infections may not improve, as it would generally
be expected, following an antibiotic treatment; this can in turn lead to
recurrent infections. As a result, patients may face repeated rounds of
antibiotics or, in some severe cases of PID, be hospitalized repeatedly for
treatment. Repeated infections can lead to organ damage, which, over time,
can become life-threatening. Some infections, such as meningitis, may even
result in death.
Nearly 100 types of PIDs exist. Most are inherited, but in some cases
the cause is unknown. No single treatment works for all of the different
types. Infusions of replacement antibodies (immunoglobulins or Ig) can help
supplement the immune system to prevent infection in nearly three-quarters
of those people living with PID whose disease is tied to an antibody
About Privigen(R) and Vivaglobin(R) Privigen(R) and Vivaglobin(R) are
human plasma-derived therapeutic products containing a broad spectrum of
immunoglobulins administered as replacement therapy in order to increase
the antibody levels in patients with immune deficiencies.
Privigen(R) is an immunoglobulin (Ig) preparation designed to be
administered via intravenous infusion. What sets it apart from other
intravenous Ig preparations is that it is stabilized with the amino acid
proline, giving it excellent stability at room temperature (25 ºC) for a
period of 24 months.
Privigen(R) is indicated for the treatment of primary and secondary
immune deficiencies as well as immune thrombocytopenic purpura (ITP), a
disorder characterized by low platelet counts due to the presence of
auto-antibodies directed against the patient’s own platelets.
Privigen(R) is contraindicated in individuals with selective IgA
deficiency as well as in patients who have had an anaphylactic or severe
systemic reaction to the administration of human immune globulin. The most
common adverse events observed with the use of Privigen(R) include:
Headache, nausea, fatigue, chills and pain.
Vivaglobin(R) is the first subcutaneously-administered Ig replacement
therapy approved in Canada. It has the added benefit of providing stable
steady-state serum Ig levels without the peaks and troughs associated with
intravenous Ig therapy.
Vivaglobin(R) has been shown in clinical studies to be safe in both
adults and children. As with any medication, side effects may accompany
treatment. The frequency of side effects was based on a review of more than
3,600 injections given during clinical trials in the United States and
Canada. The most frequently reported side effect was injection/infusion
site reaction, which generally consisted of a mild or moderate swelling,
redness, and itching at the site of injection/infusion. In clinical trials,
these reactions tended to decrease substantially after repeated use.
The most frequent adverse events reported by subjects irrespective of
causality included headache, gastrointestinal disorder, fever, nausea, sore
throat, rash, allergic reaction, pain, diarrhea and increased cough.
Because Privigen(R) and Vivaglobin(R) are made from human plasma, there
is a risk, however slight, that they contain pathogens susceptible to cause
diseases. This, in theory, also includes the agent responsible for the
Creutzfeldt-Jacob disease. For more information about Privigen(R) and
Vivaglobin(R), please contact: CSL Behring Canada, 1-866-773-7721.
About CSL Behring
CSL Behring is a global leader in the plasma protein and
biotherapeutics industry. Dedicated to improving the quality of life for
patients throughout the world, CSL Behring provides safe and effective
plasma-derived and recombinant products and offers patients a wide range of
related services. The company’s broad portfolio of life-saving therapeutics
is used in the treatment of individuals with hemophilia and other bleeding
disorders, immune deficiency disorders, and inherited emphysema; for the
prevention of hemolytic diseases for the newborn; in cardiac surgery
patients; and in shock and burn victims. Additionally, CSL Behring operates
one of the world’s largest, fully owned plasma collection networks. CSL
Behring is a subsidiary of CSL Limited, a biopharmaceutical company, which
operates worldwide from its headquarters in Melbourne, Australia. For more
information, please visit http://www.CSLBehring.com.
Sheila A. Burke
Director, Public Relations & Communications
Worldwide Commercial Operations
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