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Press Release Archive

05 December 2007
CSL Behring study in animal models shows feasibility of developing a half-life extended recombinant FVIIa that retains biologic activity
CSL Behring today announced the results of a pre-clinical study that show for the first time it is feasible to genetically fuse Factor VIIa (FVIIa) to human albumin, prolonging the half-life of this therapeutic protein while retaining its biologic activity. In the study, which was presented at the American Society of Hematology 49th Annual Meeting and Exposition, the half-life of recombinant VIIa–albumin fusion protein (rVIIa-FP) was shown to be extended 6-to-9 fold compared to wild type rFVIIa. Additionally, rVIIa-FP demonstrated a biologic activity comparable to wild type rFVIIa. More.

18 June 2007
CSL Behring Foundation Awards 10 Grants Totaling $487,000 to Benefit Bleeding Disorders Community
The CSL Behring Foundation for Research and Advancement of Patient Health has awarded more than $487,000 in funding for programs designed to benefit the bleeding disorders community. The grants will support a range of initiatives, including research projects and programs developed to educate and support patients. More.

18 May 2007
VITAL Program Launched to Educate Healthcare Providers and Patients On Administration of Subcutaneous Immunoglobulin Therapy
CSL Behring, a worldwide leader in developing subcutaneous immunoglobulin therapies, announced today the launch of a new program to educate healthcare providers and primary immunodeficiency (PI) patients on the proper technique for administering subcutaneous immunoglobulin therapy. The program, named VITAL™, an acronym for Vivaglobin Integrated Training And Learning, is being introduced to support the at-home use of Vivaglobin® (Immune Globulin Subcutaneous, Human), the first and only U.S. Food and Drug Administration-approved subcutaneous immunoglobulin (Ig) for treatment of patients with primary immunodeficiency. Vivaglobin was approved by the FDA on January 9, 2006. More.

30 April 2007
Humate-P® Approved to Prevent Excessive Bleeding in Patients with von Willebrand Disease Undergoing Surgery
Humate-P® (Antihemophilic Factor/von Willebrand Factor Complex [Human]), CSL Behring’s factor replacement therapy for the treatment of hemophilia A and von Willebrand disease (VWD), has been approved by the U.S. Food and Drug Administration (FDA) to prevent excessive bleeding during and after surgery, in patients with severe VWD and mild to moderate VWD where the use of desmopressin is known or suspected to be inadequate. The new indication approval follows the results of two separate clinical studies – one in Europe, another in the United States – that demonstrate the hemostatic efficacy and safety of Humate-P for VWD patients undergoing major, minor and oral surgical procedures. More.

02 April 2007
FDA Approves Rhophylac® for the Treatment of Immune Thrombocytopenic Purpura (ITP)
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for an additional indication for Rhophylac Rh0(D) (Immune Globulin Intravenous [Human]), an anti-D Rh immunoglobulin (Ig). The additional indication is for the treatment of immune thrombocytopenic purpura (ITP). Administered intravenously, Rhophylac is indicated to raise platelet counts in Rh0(D)-positive, non-splenectomized adult patients with chronic ITP. Having established efficacy and safety in over 10 years of use for other indications, Rhophylac offers high value pricing to help healthcare practitioners manage costs. More.

26 March 2007
CSL Therapy That Mimics "Good" Cholesterol May Reduce Plaque Volume in Coronary Arteries
CSL Limited today announced results from a study published in the Journal of the American Medical Association that suggest infusions of a novel new drug, CSL-111, to acutely raise HDL ("good" cholesterol) levels, may reduce the amount of plaque in the coronary arteries of patients with a recent episode of acute coronary syndrome (ACS). More.

07 March 2007
CSL Behring launches new online resource for patients with Hereditary Angioedema,
a rare and serious disorder

Patients with a rare disease called Hereditary Angioedema (HAE)—and their doctors—can now find comprehensive information about the condition on a new website, www.AllAboutHAE.com, launched today by CSL Behring. The site, which is designed in two sections—one for patients and the other for physicians—presents an array of features. More.

27 February 2007
Study Shows Undiagnosed Hereditary Angioedema Can Lead to Unnecessary Surgeries, Testing in Patients with Abdominal Pain
A chart review conducted by researchers at the Institute for Asthma and Allergy showed that hereditary angioedema (HAE) patients who present only with recurrent severe abdominal pain frequently undergo unnecessary surgeries and diagnostic tests prior to diagnosis. The data were presented today at the 63rd Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI). More.

27 February 2007
Study Finds C1-Inhibitor Concentrate is Safe and Effective in Treating Skin Swelling in Patients with Hereditary Angioedema
C1-inhibitor (C1-INH) concentrate is highly effective and safe in treating skin swelling in patients with hereditary angioedema (HAE), according to data presented today at the American Academy of Allergy, Asthma & Immunology (AAAAI) 63rd Annual Meeting. According to the study, relief of symptoms occurred in all treated attacks after 1.3 hours (+/- 1.4 hours) in the mean after receiving C1-INH concentrate. In all untreated attacks, the mean time to relief of symptoms was 60 hours (+/- 26.4). More.

20 February 2007
CSL Behring’s Helixate® FS and Mix2VialTM Now Packaged Together to Optimize Patient Safety and Convenience
CSL Behring has begun packaging Helixate® FS, its advanced recombinant FVIII (rFVIII) factor product for the treatment of hemophilia A, with Mix2Vial™, its needle-free transfer device. The new packaging was developed in response to comprehensive market research of customers and to meet the latest Occupational Safety and Health Administration (OSHA) requirements. More.

01 February 2007
CSL Behring and Bayer Extend Agreement
CSL Behring announced today that it has reached an agreement with Bayer HealthCare LLC to continue the supply and distribution of an important therapy for the treatment of hemophilia A. More.

08 January 2007
CSL Behring Reports Progress on Global Implementation of Name Change
The renaming program, announced by CSL Behring's parent organization, CSL Limited, last year, will present a consistent and compelling view of the company operating in new and established markets around the world. More.

19 December 2006
ZLB Behring obtains Notice of Compliance for Sandoglobulin® NF Liquid for use in the treatment of adult and pediatric patients with primary immune deficiency (PI) or secondary immune deficiency (SI) who require immunoglobulin replacement therapy
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. More.

16 November 2006
ZLB Behring Foundation Calls for Grant Applications
The ZLB Behring Foundation for Research and Advancement of Patient Health today announced that it is now accepting grant applications for programs designed to benefit the bleeding disorders community in the United States. At regular intervals throughout the year, the Foundation awards grants to qualifying organizations as a means of supporting clinical research and community-based patient programs. More.

11 October 2006
Hemophilia & Thrombosis Research Society Receives Funding from ZLB Behring To Support Mentored Research Awards
The Hemophilia & Thrombosis Research Society (HTRS) has received an unrestricted educational grant from ZLB Behring to help financially support the Society’s Mentored Research Awards. More.

18 September 2006
ZLB Behring Names Robert D. Lefebvre, Ronan W. Gannon, Garrett E. Bergman, M.D., to Top U.S. Management Posts
ZLB Behring has announced the appointment of Robert D. Lefebvre as Vice-President, General Manager, U.S. Commercial Operations. A seasoned pharmaceutical executive with over 25 years of diverse international business experience, Mr. Lefebvre is responsible for all business operations and general management accountability for all U.S. Commercial Operations at ZLB Behring, a top-ranked biopharmaceutical company specializing in plasma therapeutics. More.

12 September 2006
VIRTUE, Largest Clinical Trial of Subcutaneous Immunoglobulin Therapy, Opens to Primary Immunodeficiency Patients Across the U.S.
ZLB Behring has announced the launch of the VIRTUE Trial, a Phase IV clinical trial of the study medication Vivaglobin® (Immune Globulin Subcutaneous, Human), the first and only U.S. Food and Drug Administration-approved subcutaneous immunoglobulin (Ig) treatment for patients with primary immunodeficiency (PI). More.

22 June 2006
ZLB Behring Foundation Calls for Grant Applications
The ZLB Behring Foundation for Research and Advancement of Patient Health today announced that it is accepting grant applications for programs designed to benefit the bleeding disorders community in the United States. The Foundation awards grants at regular intervals throughout the year and supports both clinical research and community-based patient programs. More.

05 June 2006
ZLB Behring Foundation Awards Grants to Benefit Bleeding Disorders Community
The ZLB Behring Foundation for Research and Advancement of Patient Health has recently awarded funding for programs designed to benefit the bleeding disorders community. The Foundation awards grants at regular intervals throughout the year. In this cycle, nine recipients received awards. The grants support a range of initiatives, such as those that support and educate specific patient populations to research on the genetic aspect of hemophilia. More.

25 May 2006
Jeffrey Modell Foundation Opens Diagnostic Center for Primary Immunodeficiencies at Rainbow Babies and Children’s Hospital
The Jeffrey Modell Foundation (JMF), in partnership with ZLB Behring, opened the Jeffrey Modell Diagnostic Center for Primary Immunodeficiencies (PI) at Rainbow Babies and Children's Hospital today. The center is housed within the department of allergy and immunology at the hospital, and is headed by Melvin Berger, M.D. More.

23 May 2006
New International Study Group Seeks to Set Standards for Prevention, Treatment of Bleeding in Patients with von Willebrand Disease (VWD)
The von Willebrand Disease Prophylaxis Network, an international study group made up of leading bleeding disorder experts from more than 70 centers around the world, today announced the start of a study examining the use and effect of prophylactic therapy in von Willebrand disease (VWD) patients who have a history of spontaneous bleeding events. More.

22 May 2006
First International Census on von Willebrand Disease (VWD): 77 Percent of Patients with Severe Type 3 VWD Experience Significant Bleeding-Related Events
More than three-fourths of patients with Type 3 von Willebrand disease (VWD), the most severe form of the most common hereditary bleeding disorder in the world, had bleeding events in the past year that required treatment. More.

18 April 2006
State-of-the-Art ZLB Behring Plant Licensed by the FDA
ZLB Behring today announced that it has been granted a license by the U.S. Food and Drug Administration (FDA) to produce Alpha-1 Proteinase Inhibitor (Human), Zemaira®, in a new facility in its Kankakee, Illinois, manufacturing complex. More.

06 March 2006
Phase III Clinical Study Shows Vivaglobin®, a New Subcutaneous Immunoglobulin, Is Safe and Effective In Treating Patients With Primary Immunodeficiency
Data from a Phase III clinical research study, presented today at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI) in Miami Beach, Florida, demonstrate the safety and efficacy of new Vivaglobin® (Immune Globulin Subcutaneous [Human]), an immunoglobulin replacement therapy for treating patients with primary immunodeficiency (PI). Vivaglobin recently became the first and only Food and Drug Administration-approved subcutaneous (SC) Immunoglobulin (Ig) treatment and can be safely self-administered by PI patients under a physician’s care in the United States. More.

05 March 2006
Study Shows Individual Replacement Therapy with C1-Inhibitor Concentrate Reduces Life-Threatening Hereditary Angioedema Attacks Compared With Current Treatment of Choice
Researchers concluded that individual replacement therapy (IRT) with C1-inhibitor (C1-INH) concentrate in patients with severe hereditary angioedema (HAE) significantly reduces the frequency of HAE attacks – especially life-threatening attacks – and significantly improves quality of life, compared to danazol. More.

05 March 2006
Study Finds Treatment with C1-Inhibitor Concentrate Relieves Abdominal Pain in Hereditary Angioedema Patients
C1-inhibitor (C1-INH) concentrate is effective in safely relieving abdominal pain and abdominal-wall tension in patients with hereditary angioedema (HAE) who experience abdominal attacks, according to data presented today at the American Academy of Allergy, Asthma & Immunology (AAAAI) 62nd Annual Meeting. According to the study, the first to report detailed and quantitative data on treated and untreated attacks of HAE in this large a sample size, in most attacks, relief of these symptoms occurred within 30 to 150 minutes after receiving C1-INH concentrate. More.

15 February 2006
ZLB Behring Announces Availability of Humate-P® with Smaller Diluent
ZLB Behring today announced that Humate-P® (Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized) is now available featuring a smaller diluent - 50 percent less in all assay sizes. More.

07 February 2006
CSL to Apply for License to Market Influenza Vaccine in the U.S.
CSL Limited (ASX: CSL), a global, specialty biopharmaceutical company headquartered in Melbourne, Australia, today announced plans to introduce its influenza vaccine into the U.S. market. More.

09 January 2006
ZLB Behring Announces FDA Approval of Vivaglobin® -- The First Subcutaneous Immunoglobulin Replacement Therapy Approved in the U.S.
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. More.

27 October 2005
Two-and-a-Half Million Women May Have A Bleeding Disorder…Without Even Knowing It
As many as 2.5 million women may have an undiagnosed bleeding disorder that, if not properly treated, could lead to serious health problems, medical experts told a mostly female audience at the National Hemophilia Foundation’s (NHF) 57th Annual Meeting today. Women with some forms of von Willebrand Disease (vWD) are at greater risk for miscarriage, life-threatening bleeding following surgery and childbirth, and for undergoing unnecessary hysterectomies. More.

12 October 2005
Infusion Nurses Examine Need for Standards of Practice in Immunoglobulin Therapy
A review article published in the July/August 2005 Journal of Infusion Nursing examines the need for established treatment guidelines to support doctors and nurses in correctly dosing and administering intravenous immunoglobulin (IVIG) as replacement therapy in patients with primary immunodeficiency (PI) disorders, who do not produce adequate levels of antibodies essential in fighting infectious diseases. More.

07 October 2005
FDA Approves Room Temperature Storage of ZLB Behring's Helixate® FS
ZLB Behring announced today that Helixate® FS has received approval to be stored at room temperature (up to 25°C, 77°F) for three months. The new storage guidelines for the treatment will provide users with greater flexibility and simplify storage options. More.

08 September 2005
ZLB Behring Lends Support to Patient Communities Affected by Hurricane Katrina
ZLB Behring Lends Support to Patient Communities Affected by Hurricane Katrina. ZLB Behring and its employees are making a number of donations in response to the devastation created by Hurricane Katrina. We are particularly concerned about the additional hardship this has placed on the patient communities we serve. As part of our ongoing commitment to the patient communities, we are providing additional support during this difficult time. More.

25 July 2005
ZLB Behring Introduces the Mix2Vial™ Alternate Transfer Device
Behring announced today the availability of the Mix2Vial Alternate Transfer Device, a new way to reconstitute products in 20/20 mm vials. More.