ZLB Behring Announces FDA Approval Of Vivaglobin(R); The First Subcutaneous Immunoglobulin Replacement Therapy Approved In The U.S.

KING OF PRUSSIA, Pa., Jan. 9 /PRNewswire/ -- ZLB Behring today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Vivaglobin® (Immune Globulin Subcutaneous [Human]), an immunoglobulin (Ig) replacement therapy for treating patients with primary immunodeficiency (PI). Vivaglobin is the first and only FDA-approved subcutaneous (SC) Ig treatment, and can be safely self-administered by PI patients under a physician's care in the United States. Vivaglobin is manufactured and marketed by ZLB Behring.

Vivaglobin 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 safe home self-administration of Ig replacement therapy.

"This milestone achievement means that thousands of patients with primary immunodeficiencies now have a brand new treatment option that was specifically designed to make their lives easier," said Paul Perreault, Executive Vice President, Worldwide Commercial Operations. "ZLB Behring is dedicated to providing unique, innovative solutions that help save lives. Vivaglobin is a clear example of that commitment."

PI is a usually-genetic group of disorders that compromise the immune system, leaving people vulnerable to often, life-threatening infections.(1) An estimated 50,000 Americans have PI.(2)

Immunoglobulin is a life-sustaining blood product that has become standard immune replacement therapy for most people living with PI, and nearly 70 percent of PI patients receive Ig replacement therapy. Since the 1980s, the first-line therapy for most PI patients has been intravenous immunoglobulin (IVIg), in which a pump delivers the immunoglobulin through a needle into the vein.(3) Experience shows IVIg to be an effective, safe, life-saving treatment. However, many patients may not easily tolerate intravenous infusions because they have poor venous access or they experience serious side effects.(4) Vivaglobin allows patients to use a small, portable pump to self- administer their weekly subcutaneous infusions. With Vivaglobin administration, peak serum Ig levels are lower than those achieved with IVIg. Subcutaneous administration results in relatively stable steady-state serum Ig levels when administered on a weekly basis. This serum Ig profile is representative of that seen in a normal population.

"The approval of Vivaglobin is a true breakthrough in managing primary immunodeficiencies and marks the beginning of a new treatment era in the U.S.," said Melvin Berger, M.D., a professor of pediatrics at Case Western Reserve University and one of the investigators on ZLB Behring's clinical study of Vivaglobin. "Physicians now have the ability to select from a wider array of options in providing care to their primary immunodeficiency patients. Vivaglobin offers those patients the convenience of self-administration and, therefore, the opportunity to enjoy improved quality of life."

Clinical Studies

The FDA approved Vivaglobin based on results of a pivotal open-label, prospective, multicenter clinical study conducted in the United States and Canada, evaluating the pharmacokinetics, efficacy, safety and tolerability of Vivaglobin in adult and pediatric subjects with PI. In this study, 65 adult and pediatric PI subjects previously treated monthly with IVIG were switched to weekly subcutaneous administrations of Vivaglobin for 12 months. Subjects received a weekly mean Vivaglobin dose of 158 mg/kg body weight which was 136% of their previous weekly-equivalent IGIV dose.

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. Pneumonia was reported in two subjects. The annual rate of any infections, a secondary endpoint, was 4.4 infections per subject per year.

A 6-month, non-IND study of Vivaglobin was conducted in Europe and Brazil and generated safety and efficacy data similar to those reported in the clinical study conducted in the United States and Canada.

Vivaglobin was previously approved in a number of European countries and a market application in Canada is currently under review.

Commercial preparations are underway to make Vivaglobin available to PI patients in the United States who desire this new treatment option.

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.(1) 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.(5)

Nearly 100 types of PIs exist.(6) Most are inherited, but in some cases the cause is unknown.(2) 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.(2)

For more information on PI, please visit http://www.zlbbehring.com or contact the leading PI patient advocate groups in the U.S., the Immune Deficiency Foundation (http://www.primaryimmune.org) and the Jeffrey Modell Foundation (http://www.jmfworld.com).

Important Safety Information

In clinical studies, Vivaglobin has been shown 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 the clinical trial in the United States and Canada. The most frequently reported side effect was injection/infusion site reaction, which generally consisted of 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 Vivaglobin is made from plasma, as are all commercial immunoglobulins, the risk of transmitting infectious agents, including viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

For more details and complete prescribing information on Vivaglobin, please visit http://www.vivaglobin.com, or call the ZLB Behring Medical Information Department at 1-800-504-5434.

About ZLB Behring

ZLB Behring is a global leader in the plasma protein 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 http://www.ZLBBehring.com.


(1) Lindegren ML, Kobrynski L, Rasmussen SA, et al. Applying Public Health Strategies to Primary Immunodeficiency Diseases: A Potential Approach to Genetic Disorders. MMWR. 2004; 53(RR-1):1-29. (2) Primary Immune Deficiency Diseases in America. The First National Survey of Patients and Specialists. Available at: http://www.primaryimmune.org/pid/patient_survey_publication.pdf. Accessed December 2005. (3) Buckley RH, Schiff RI. The Use of Intravenous Immune Globulin in Immunodeficiency Diseases. N Engl J Med. 1991;325(2):110-7. (4) Berger M. Subcutaneous Immunoglobulin Replacement in Primary Immunodeficiencies. Clin Immunol. 2004; 112(1):1-7. (5) Primary Immunodeficiency. National Institute of Child Health & Human Development Web site. Available at: http://www.nichd.nih.gov/publications/pubs/primaryimmunobooklet.htm#WhatisPrim aryImmunocdeficiency. Accessed December 2005. (6) About Primary Immune Deficiencies. What is a Primary Immune Deficiency Disease? Immune Deficiency Foundation Website. Available at: http://www.primaryimmune.org/pid/whatis_pid.htm. Accessed December 2005.

Source: ZLB Behring

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