ZLB Behring today announced that Health Canada has granted the company authorization to market Sandoglobulin® NF Liquid throughout Canada. Marketing will be accomplished by ZLB Behring Canada, Inc. Sandoglobulin® NF Liquid (Immune Globulin (Human)), which is administered intravenously, is indicated for the treatment of adult and pediatric patients who have conditions known as primary immune deficiency (PI) or secondary immune deficiency (SI), both of which are rare and life-threatening. Authorization was granted on November 3, 2006.

ZLB Behring has also secured from Health Canada the authorization to market Vivaglobin™ in Canada, also by ZLB Behring Canada, Inc. That authorization was secured on June 22, 2006. Vivaglobin™ is a human immunoglobulin (Ig) replacement therapy for treating patients with PI and can be self-administered subcutaneously (under the skin) by PI patients under a physician's care. Vivaglobin™ represents the first and only subcutaneous therapy for PI to be licensed in Canada.

With these two Health Canada authorizations, ZLB Behring becomes the only manufacturer in Canada to have two formulations in which this class of product is offered: liquid designed for intravenous administration of Immune Globulin (human) (Sandoglobulin® NF Liquid), and liquid designed for subcutaneous administration of Immune Globulin (Human)(Vivaglobin™).

"This Health Canada marketing approval is an extremely positive development," said Dr. Heinz Neuhaus, General Manager of ZLB Behring Canada. "Sandoglobulin NF Liquid and Vivaglobin are both treatments for what is often a life-threatening and extremely serious health condition. We are pleased to be in a position to supply patients and their physicians greater potential options in how this serious health need is managed."

About Primary Immunodeficiencies
PIs are a group of usually genetic disorders that cause a malfunction in part or all of the immune system, keeping the patient from fighting off infections caused by everyday germs. For individuals with PI – many of them children – infections may not improve with treatment as expected, and may keep returning. As a result, patients may face repeated rounds of antibiotics or be hospitalized for treatment. Repeated infections can lead to organ damage, which, over time, can become life-threatening. In some severe cases of PI, infections may result in a patient being hospitalized repeatedly. Some infections, such as meningitis, may even result in death.

Nearly 100 types of PIs 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 PI whose disease is tied to an antibody deficiency.

About Sandoglobulin® NF Liquid
Sandoglobulin® NF Liquid, Immune Globulin Intravenous (Human), is a clear or slightly opalescent, colorless or pale yellow solution of unmodified human immunoglobulin. The concentration of the active ingredient in Sandoglobulin® NF Liquid is 12% (120 g/L). Sandoglobulin® NF Liquid is available in doses of 6 grams (50 ml) and 12 grams (100 ml). Recommended product storage is refrigerated (+2 °C to +8 °C).

Sandoglobulin® NF Liquid, is indicated for the treatment of adult and pediatric patients with primary immune deficiency (PI) or secondary immune deficiency (SI) who require immunoglobulin replacement therapy.

Health Canada provided the Notice of Compliance for Sandoglobulin® NF Liquid based on the results of two phase III studies, one conducted in Europe and one conducted in Canada and the United States. The European study was a multi-center, randomized, double-blind, active controlled study designed to assess the safety and efficacy of Sandoglobulin® NF Liquid in patients with PI. The primary efficacy variable, the number of days out of work or school or unable to perform normal daily activities due to underlying primary deficiency disorder, was not significantly different between the groups. The mean monthly average day was less than one for both treatment groups. The most common adverse events were rhinitis, upper respiratory tract infection and headache.

The Canadian and U.S. study was a multi-center, open, single-arm study designed to demonstrate safety in PI subjects by evaluation of the number of infusions temporally associated with adverse events regardless of relationship during a treatment period of 6 months. The efficacy variables were evaluated as secondary endpoints. The proportion of infusions temporally associated with adverse events was 0.32. The corresponding upper bound of the 2-sided 95% CI was 0.394, and thus, the primary study objective was met. During the 6-month study period, there were no episodes of acute serious bacterial infection defined as pneumonia, meningitis, bacteremia/septicemia, osteomyelitis, septic arthritis and visceral abscess. The annualized rate of days out of work, school, kindergarten, or daycare, or without the ability to perform normal activities, was 5.61. The annualized rate of days hospitalized was approximately 0.9 days. The most frequent adverse events were headache, pharyngolaryngeal pain and sinusitis. Infusion of Sandoglobulin® NF Liquid was well tolerated.

About Vivaglobin™
Vivaglobin™, Immune Globulin Subcutaneous (Human), is a pasteurized, polyvalent human normal immunoglobulin for subcutaneous infusion. Vivaglobin™ consists of a 16% protein solution in 22.5 mg/ml glycine. Recommended product storage is refrigerated (+2 °C to +8 °C).

Vivaglobin™ is manufactured from large pools of human plasma by cold alcohol fractionation and is not chemically altered or enzymatically degraded. Vivaglobin™ contains no preservative. Vivaglobin™ is indicated for the treatment of adult and pediatric patients with primary immune deficiency (PI) who require immune globulin replacement therapy. It delivers treatment directly under the skin (subcutaneously), offering a safe and effective alternative to intravenous infusions of immunoglobulin. Vivaglobin™ represents another treatment option for patients who may not easily tolerate the currently available intravenous method because they have poor venous access or experience serious side effects from that method. Vivaglobin™ also is appropriate for those who want the freedom and convenience of home self-administration of Ig replacement therapy.

Health Canada provided the Notice of Compliance for Vivaglobin™ based on the results of two open-label, prospective, multi-center, multinational clinical studies; one study was conducted in Canada and the USA and the other was conducted in Europe and Brazil. These two studies evaluated the pharmacokinetics, efficacy, safety and tolerability of Vivaglobin™ in adult and pediatric subjects with primary immune deficiency (PI).

In the Canadian and U.S. study, the annual rate of serious bacterial infections (defined as bacterial pneumonia, meningitis, sepsis, osteomyelitis, and visceral abscesses), the primary endpoint, was 0.04 infections per subject per year (one-sided upper 99% confidence interval: 0.14) for the pre-protocol set (n = 51). Pneumonia was reported in two subjects. The annual rate of any infections, a secondary endpoint, was 4.4 infections per subject per year.

In the study conducted in Europe and Brazil, the annualized rate of serious infections was 0.04 infections per subject per year (one-sided upper 99% confidence interval: 0.21). Pneumonia was reported in one subject. The annualized rate of any infections was 4.3 infections per subject per year.

In the clinical studies, Vivaglobin™ was shown to be safe in both adults and children. The most frequent adverse reactions were local reaction at the site of injection, which generally consisted of mild or moderate swelling, redness, and itching at the site of injection /infusion. Most of these reactions resolved within four days.

The most frequent adverse events by subject, irrespective of causality, included headache, gastrointestinal disorder, fever, nausea, sore throat, rash, allergic reaction, skin disorder, pain, diarrhea and increased cough.

Because Sandoglobulin® NF Liquid and Vivaglobin™ are both made from plasma, as are all immunoglobulins, the risk of transmitting infectious agents, including viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated. The product monographs or full prescribing information for Sandoglobulin® NF Liquid and Vivaglobin™ are available on request from ZLB Behring Canada, 55 Metcalfe Street, Ottawa , Ontario, K1P 6L5, Fax 1-613-232-5031.

About ZLB Behring
ZLB Behring is a global leader in the plasma protein and biotherapeutics industry. Dedicated to improving the quality of life for patients throughout the world, ZLB 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, ZLB Behring operates one of the world's largest, fully owned plasma collection networks. ZLB 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.ZLBBehring.com.

Media contact:
Jeff Hoyak
MCS Public Relations for ZLB Behring
908-234-9900, ext. 12
jeffh@mcspr.com