CSL Behring Signs Agreements with Canadian Blood Services and Héma-Québec to Supply Life-Saving Therapies
Company Joins Supplier Base Offering Broad Array of Healthcare Products to Patients with Immune Deficiency and Bleeding Disorders
Ottawa, Canada — 01 April 2008
CSL Behring Canada, Inc. today announced that Canadian Blood Services, and Héma-Québec, have each awarded the company contracts to supply Helixate® FS ( Antihemophilic Factor [Recombinant]), Humate® P (Antihemophilic factor / von Willebrand Factor Complex [Human], Dried, Pasteurized), Privigen (Immune Globulin Intravenous [Human]), Vivaglobin® (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 Héma-Québec 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 Décary, President and CEO of Héma-Québec. “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 Quebec.”
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. 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. More serious symptoms include bleeding into joints and internal organs. Women with VWD are more likely to experience abundant, prolonged menstruation.
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®, Antihemophilic Factor/von Willebrand Factor Complex (Human) Dried, Pasteurized; and oral contraceptives to reduce menstrual bleeding and raise von Willebrand factor in the bloodstreamii.
About Helixate® FS and Humate-P®
Helixate® 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® FS should be administered cautiously in patients with previous hypersensitivity to constituents of FVIII preparations or known sensitivity to mouse or hamster protein.
Helixate® 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 www.allaboutbleeding.com.
Adverse events related to the use of Helixate ® FS are generally minor. The most common events include injection-site reactions, dizziness and rash.
Humate-P® 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® 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® 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 Creutzfeldt-Jacob disease.
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® FS or Humate-P®.
For more information about Helixate® 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 deficiency.
About Privigen® and Vivaglobin®
Privigen® and Vivaglobin® 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® 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® 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® 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® include: Headache, nausea, fatigue, chills and pain.
Vivaglobin® 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® 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® and Vivaglobin® 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® and Vivaglobin®, 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 www.CSLBehring.com.
Sheila A. Burke
Director, Public Relations & Communications
Worldwide Commercial Operations
Laura de Zutter
i National Heart, Lung and Blood Institute Disease and Conditions Index. Who gets von Willebrand disease? Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/vWD/vWD_WhatIs.html. Accessed October 25, 2005.
ii AllAboutBleeding.com. What is von Willebrand Disease (VWD)? Available at: http://www.allaboutbleeding.com/vwd_and_you/view.asp?id=4634. Accessed October 25, 2005.