Global

News Releases

18 August 2010
CSL Behring Receives FDA Approval to Extend Shelf Life of Hizentra® from 18 Months to 24 Months
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to extend the shelf life of Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, from 18 months to 24 months. Hizentra, the first and only 20 percent subcutaneous immunoglobulin (SCIg) approved in the U.S. by the FDA, is also the first and only SCIg in the U.S. that may be stored at room temperature. More.

23 June 2010
CSL Behring Awards Grassroots Advocacy Grants To Patient Organizations In Maryland, California, Tennessee, Montana
CSL Behring, a global leader in the plasma-protein biotherapies industry and a subsidiary of CSL Limited (ASX:CSL), has awarded advocacy grants totaling almost $50,000 to four patient organizations through the Local Empowerment for Advocacy Development (LEAD) program. LEAD grants support the grassroots advocacy efforts of organizations committed to helping people who use plasma-derived or recombinant therapies to manage rare and serious diseases. More.

01 June 2010
CSL Behring Receives Canadian Notice of Compliance for Berinert®
CSL Behring Canada announced today that it has received Notice of Compliance for Berinert® (Human C1 Esterase Inhibitor). The company may now market Berinert for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) of moderate and severe intensity. HAE is a rare and serious genetic disorder. More.

27 May 2010
CSL Behring announces completion of national marketing authorizations of Berinert® after MRP in 23 European countries
CSL Behring announced today it has been granted national marketing authorization in Italy and Luxembourg to market Berinert® for the treatment of acute hereditary angioedema (HAE) attacks in any body location. This latest authorization brings to 28 the number of countries (in Europe, Asia, North America, South America and Australia) in which Berinert is now licensed. More.

18 May 2010
CSL Behring Announces Locations and Host Partners for its 9th Annual Gettin’ in the GameSM Junior National Championship
CSL Behring announced today the schedule for its 9th annual Gettin’ in the GameSM Junior National Championship (JNC) competition in golf and baseball. The JNC is a series of one-day athletic events for children with bleeding disorders, such as hemophilia or von Willebrand disease (VWD), and their families. During the JNC young people with a bleeding disorder have the opportunity to connect with and compete against others who have these conditions. The competitions also encourage kids with bleeding disorders to be committed to physical activity that helps keep their muscles healthy and joints strong. More.

14 May 2010
CSL Behring Medical Product Donation Helps Meet Critical Need for Ongoing Relief Effort in Haiti
Direct Relief International announced today that CSL Behring has donated life-saving medicines valued at more than $100,000 to assist earthquake victims in Haiti who are at risk of tetanus or hepatitis B infections. The products will be used in clinics at Hôpital Albert Schweitzer in Deschapelles. More.

13 May 2010
Young Women Urged to Recognize Symptoms of Widely Undiagnosed Bleeding Disorder
To promote the importance of screening young women for von Willebrand disease (VWD), the American Academy of Nurse Practitioners (AANP) today announced the launch of its VWD Young Women’s Education Campaign. Sponsored by CSL Behring, this educational initiative is designed to inform teenage girls and their healthcare providers about the five signs and symptoms of VWD, the most common hereditary bleeding disorder. More.

19 April 2010
CSL Behring Receives FDA Approval to Extend Shelf Life for Privigen® from 24 to 36 Months
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to extend the shelf life for Privigen®, Immune Globulin Intravenous (Human), 10% Liquid, from 24 to 36 months. The approval makes Privigen the first liquid intravenous immunoglobulin (IVIg) in the U.S. that can be stored at room temperature throughout its entire 36-month shelf life. More.

16 April 2010
CSL Behring Marks World Hemophilia Day with Factor IX Donation to World Federation of Hemophilia
Hemophilia B patients in the developing world will benefit from a recent donation of 1 million international units (IU) of factor IX medication made by CSL Behring to the World Federation of Hemophilia (WFH). The donation, channeled through WFH’s United Kingdom chapter, marks World Hemophilia Day 2010 and will support WFH’s progress in improving the diagnosis and treatment of hemophilia in developing countries through its Global Alliance for Progress (GAP) program. More.

12 April 2010
CSL Behring Seeking Proposals for LEAD Grants to Support Patient Advocacy Efforts
CSL Behring, a global leader in the plasma protein biotherapeutics industry, is calling for grant requests through its Local Empowerment for Advocacy Development (LEAD) program. The LEAD program awards funds to United States patient organizations that assist people with rare diseases in advocating for continued access to health care and life-saving plasma protein therapies. More.

04 March 2010
CSL Behring Receives FDA Approval of Hizentra™, First 20 Percent Subcutaneous Immunoglobulin Therapy
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Hizentra™, Immune Globulin Subcutaneous (Human), 20% Liquid, for treating patients diagnosed with primary immunodeficiency (PI). A once weekly immunoglobulin (Ig) replacement therapy, Hizentra provides effective protection against infection by maintaining a steady and normal level of immunoglobulin in the body. Primary immunodeficiencies constitute a group of disorders, usually genetic, that cause a malfunction in all or part of the immune system, thereby rendering the patient unable to fight off infections caused by everyday germs. More.

01 March 2010
Surveys Reveal High Frequency of Prodromal Symptoms Prior to Acute Hereditary Angioedema Attacks
Patients with hereditary angioedema (HAE) experience prodromal or early warning symptoms before nearly three-quarters of their HAE attacks, according to survey findings presented today at the 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. According to researchers, this high frequency suggests that prodromal symptoms may reliably indicate when to initiate treatment to help prevent an acute HAE attack. More.

01 March 2010
Study Shows C1-Esterase Inhibitor Concentrate Rapidly Relieves Acute, Successive Attacks of Hereditary Angioedema at All Body Sites
C1-esterase inhibitor (C1-INH) concentrate is an effective, well-tolerated therapy that rapidly relieves acute swelling attacks and successive attacks at any body location in patients with hereditary angioedema (HAE), a rare and serious genetic disorder, according to data presented today at the 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. Additional pharmacokinetic data presented at the meeting confirms that C1-INH concentrate has a longer half-life than other treatment options for HAE, which protects patients from rebound attacks. More.

01 March 2010
IgPro20, the First 20 Percent Subcutaneous Immunoglobulin, Demonstrates Efficacy Against Infections While Maintaining Tolerability in Patients with Primary Immunodeficiency
Data presented today suggest that 20 percent liquid formulation, Immune Globulin Subcutaneous (Human) (SCIg), or IgPro20 effectively protects patients with primary immunodeficiencies (PI) against infection. The 20 percent formulation, the highest Ig concentration currently available, was also shown to sustain serum IgG levels without causing unexpected rates of adverse events. The data were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in New Orleans, LA, US. More.

01 March 2010
European Data Suggest Switching Patients to IgPro20 May Significantly Reduce Drug Administration Volume
Data from a European multicenter (non-IND study) showing that patients with PI who switched to IgPro20 from previously available SCIg formulations achieved comparable IgG trough levels without dosage adjustment, resulting in significantly less administration volume. The data were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in New Orleans, LA, US. More.

01 March 2010
New Data Show IgPro20 Delivers Highest Available Subcutaneous Ig Concentration with Tolerability Comparable to Current Treatments
Data presented today show that IgPro20, the first 20 percent liquid formulation, delivers a higher concentration of treatment, with no trade-off in terms of local tolerability relative to currently marketed subcutaneous immunoglobulin (SCIg) products. The data were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in New Orleans, LA, US. More.

04 February 2010
Global SWIFT Studies Will Evaluate Safety and Efficacy of CSL Behring’s Biostate® for von Willebrand Disease and Hemophilia A
CSL Behring announced today the start of the global clinical trial program SWIFT (Studies with von Willebrand factor [VWF]/Factor VIII) to evaluate the pharmacokinetics, efficacy and safety of Biostate®, a low-volume, highly active, plasma-derived VWF/FVIII concentrate for the treatment of von Willebrand disease (VWD) and hemophilia A. The methodology behind the multi-center trials was detailed in a presentation at the 3rd Annual Congress of the European Association of Haemophilia and Allied Disorders (EAHAD) today. More.

27 January 2010
CSL Behring Launches Berinert® Expert Network (B.E.N.™), Support System for Hereditary Angioedema Healthcare Providers, Patients and Caregivers
CSL Behring announced today the launch of the Berinert® Expert Network (B.E.N.™ ), a full-service support program for healthcare providers and for hereditary angioedema (HAE) patients and their caregivers. HAE is a rare and serious disorder that causes swelling in various parts of the body. In October the U.S. Food and Drug Administration (FDA) granted marketing approval for Berinert C1-Esterase Inhibitor, Human for the treatment of acute abdominal or facial attacks of HAE, a rare and serious genetic disorder, in adult and adolescent patients. The safety and efficacy of Berinert for prophylactic therapy have not been established. Berinert is now available through specialty pharmacies and distributors in the United States. More.

29 December 2009
CSL Behring Awards Fourth Round of LEAD Grants
CSL Behring, a global leader in the plasma-protein biotherapies industry and a subsidiary of CSL Limited (ASX:CSL), has awarded four advocacy grants totaling $87,000 to patient organizations in the United States through the Local Empowerment for Advocacy Development (LEAD) program. LEAD grants support grassroots advocacy efforts by organizations committed to helping people who use plasma-derived or recombinant therapies manage their health conditions. Since the LEAD program’s inception in 2008, CSL Behring has awarded more than $340,000 in four semi-annual grant cycles. The deadline for the fifth round of grant requests is April 30, 2010. More.

09 November 2009
Patient and Healthcare Provider Convenience Focus of Packaging Enhancements for Humate-P from CSL Behring
CSL Behring has begun packaging Humate-P® (Antihemophilic Factor/von Willebrand Factor Complex [Human]) in a more user-friendly package based on customer market research. These packaging enhancements strive to improve the convenience of treatment for people with von Willebrand disease (VWD), the most common hereditary bleeding disorder in the United States. According to the Centers for Disease Control and Prevention, VWD affects approximately 1 to 2 percent of the U.S. population. More.

29 October 2009
Junior Athletes Honored by CSL Behring at National Hemophilia Foundation's Annual Meeting
CSL Behring announced today the national winners of the 8th annual Gettin’ in the GameSM Junior National Championship (JNC). Developed by CSL Behring, provider of the hemophilia treatment Helixate® FS (Antihemophilic Factor, Recombinant), the JNC is a series of one-day events held throughout the country that provide hundreds of children with bleeding disorders the opportunity to participate in a golf and baseball competition. More.

12 October 2009
CSL Behring Announces FDA Approval of Berinert®, First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S.
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Berinert® C1-Esterase Inhibitor, Human for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE), a rare and serious genetic disorder, in adult and adolescent patients. Berinert is the first and only therapy approved for this indication in the U.S. The approval is based on the results of the phase II/III prospective, double-blind placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.), which studied the efficacy and safety of C1-inhibitor (C1-INH) concentrate. The safety and efficacy of Berinert for prophylactic therapy have not been established. More.

06 October 2009
CSL Behring Solicits Proposals for LEAD Grants to Support Patient Advocacy Efforts
CSL Behring, a global leader in the plasma-protein biotherapeutics industry, is calling for grant requests through its Local Empowerment for Advocacy Development (LEAD) program. The LEAD program awards funds to United States patient organizations that assist people with rare diseases in advocating for continued access to health care and life-saving plasma protein therapies. More.

21 September 2009
Helixate FS from CSL Behring Now Available in 3000 IU Dosage Strength to Improve Patient Convenience
Hemophilia A patients who require high doses of Helixate® FS, Antihemophilic Factor (Recombinant), can now benefit from greater convenience in administering their treatment, thanks to a new 3000 IU (international unit) dosage strength. CSL Behring announced today that this new dosage strength is available in the U.S., allowing many patients to reduce reconstitution time by eliminating the need to mix and pool multiple vials of Helixate FS. More.

28 July 2009
CSL Behring Awards Third Round of LEAD Grants Supporting Patient Organization Advocacy
CSL Behring, a global leader in the plasma-protein biotherapies industry, has awarded six advocacy grants totaling $100,000 to patient organizations in the United States through the Local Empowerment for Advocacy Development (LEAD) program. LEAD grants support grassroots advocacy efforts by organizations that are committed to helping people who use plasma-derived and recombinant therapies to manage their health conditions. Since the LEAD program’s inception in 2008, CSL Behring has awarded more than $250,000 in three semi-annual grant cycles. More.

08 June 2009
CSL Limited and Talecris Biotherapeutics Agree to Terminate Merger Agreement
CSL Limited (ASX: CSL) and Talecris Biotherapeutics, Inc. announced today that they have mutually agreed to terminate their merger agreement, announced on August 12, 2008, under which CSL agreed to acquire Talecris for US$3.1 billion in cash. More.

18 May 2009
ZLB Plasma Changes Name to CSL Plasma
ZLB Plasma has changed its name to CSL Plasma to align more closely with its parent company, CSL Limited. CSL Plasma is one of the world’s largest collectors of human plasma for use in manufacturing life-saving biotherapies. Headquartered in Boca Raton, FL, CSL Plasma operates collection centers throughout the United States and in Germany. It also operates state-of-the-art testing laboratories in Knoxville, TN and Goettingen, Germany, and logistics centers in Indianapolis, IN and Schwalmstadt, Germany. More.

04 May 2009
Patient Convenience Focus of New Upgrades to HeliTrax System by CSL Behring
Hemophilia A patients and their treatment providers are now better able to manage their condition, thanks to an enhanced HeliTrax™ System from CSL Behring. Patients can now track and record their treatment progress in real time anywhere that internet access is available. By using a password-protected web interface, hemophilia A patients can easily input their treatment data and monitor their condition online even when they are not carrying their handheld electronic diary. More.

01 May 2009
CSL Behring Submits BLA Requesting Approval of Subcutaneous Human Immunoglobulin for Use as Replacement Therapy in Patients with Primary Immunodeficiencies
CSL Behring announced today it has submitted a biologics license application (BLA) to the United States Food and Drug Administration (USFDA) requesting approval to market its 20 percent liquid formulation, Immune Globulin Subcutaneous (Human) (IgSc), in the United States for weekly replacement therapy in patients with primary immunodeficiencies (PI). More.

17 April 2009
CSL Behring Marks World Hemophilia Day with $2M Coagulation Factor Donation to World Federation of Hemophilia
In recognition of the World Federation of Hemophilia’s (WFH) progress in improving the diagnosis and treatment of hemophilia in developing countries through its Global Alliance for Progress (GAP) program, CSL Behring has committed to donating to WFH two (2) million units of factor VIII concentrate (FVIII) each year for the next three (3) years. The donation, the total value of which will be approximately $2 million, will be made using coagulation factor concentrate with a minimum shelf-life of one year. More.

02 April 2009
CSL Behring to Launch Next GameFaces™ Program Challenge
CSL Behring announced it will hold its next GameFaces™ challenge from April 14 through July 7, 2009. GameFaces is a family-oriented, online initiative for people with hemophilia A. The program is designed to encourage real-life physical activity through a series of customized challenges based on the individual’s age, disease severity and current level of physical activity. More.

31 March 2009
CSL Behring Seeking Proposals for LEAD Grants to Support Patient Advocacy Efforts
CSL Behring, a global leader in the plasma-protein biotherapeutics industry, is calling for grant requests through its Local Empowerment for Advocacy Development (LEAD) program. The LEAD program awards funds to United States patient organizations that assist people with rare diseases in advocating for continued access to health care and life-saving plasma protein therapies. More.

15 March 2009
Rapid Treatment of Hereditary Angioedema Attacks at the Onset of Prodromal Symptoms Decreases Morbidity and Mortality
The importance of recognizing prodromal symptoms and treating acute attacks of hereditary angioedema (HAE) at the onset of these symptoms was highlighted in a survey presented today at the 2009 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. While symptoms of acute HAE attacks include episodes of edema or swelling in the hands and feet, the face, the abdomen, and/or the larynx, prodromal symptoms, which occur before an attack, are often non-specific and highly-variable, according to study findings. Treatment at the onset of these early symptoms can decrease morbidity and mortality associated with this rare and serious genetic disorder. More.

15 March 2009
C1-Esterase Inhibitor Concentrate Rapidly Relieves Acute Swelling Attacks Across All Body Sites in Patients with Hereditary Angioedema, According to Study
C1-esterase inhibitor (C1-INH) concentrate is an effective, well-tolerated therapy that rapidly relieves acute swelling attacks at any body location in patients with hereditary angioedema (HAE), a rare and serious genetic disorder, according to data presented today at the 2009 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. Interim results from the ongoing, prospective, open label International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T. 2), showed a median time to the onset of symptom relief of 16 minutes for laryngeal attacks, 23 minutes for abdominal attacks, 28 minutes for facial attacks and 31 minutes for peripheral attacks, such as attacks in the hands and feet. In total, 57 patients who experienced 640 HAE attacks in any body location were studied. More.