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2013 News Releases

2013 News Releases

CSL Behring Study Shows Kcentra® Superior to Plasma for Warfarin Reversal in Patients Requiring an Urgent Surgical Procedure
09 Dec 2013

Data presented today by CSL Behring at the 55th Annual Meeting of the American Society of Hematology (ASH) showed Kcentra® (Prothrombin Complex Concentrate [Human]) was superior to plasma, the current standard of care in the U.S., in adult patients taking vitamin K antagonist therapy (VKA; e.g., warfarin) who required warfarin reversal prior to an urgent surgery or invasive procedure. Kcentra, the first non-activated 4-factor prothrombin complex concentrate (4F-PCC), was approved by the FDA in April 2013 for the urgent reversal of warfarin therapy in adult patients with acute major bleeding. Kcentra is not indicated for urgent reversal of VKA anticoagulation in patients without acute major bleeding and is not indicated for use in patients on VKA therapy requiring an urgent surgery or invasive procedure as evaluated in this study.

Sustainable Development And Responsible Business Practice Aren't Just Words At The CSL Group Of Companies
02 Dec 2013

CSL Behring’s parent company CSL Limited (ASX:CSL) reaffirms the companies’ commitment to responsible business practice and sustainable development in its new corporate responsibility report – Our Corporate Responsibility 2013. The report details CSL’s performance across key corporate responsibility priority areas for the period July 1, 2012 through June 30, 2013.

CSL Behring Launches Innovative Test Kit Designed to Improve Diagnosis of Alpha-1
25 Nov 2013

CSL Behring today announced the availability of DNA1 Advanced Alpha-1 ScreeningTM (DNA1), a new test that aims to improve diagnosis of Alpha-1 Antitrypsin Deficiency (Alpha-1). Launched during Alpha-1 Awareness Month, DNA1 is the only comprehensive Alpha-1 test available that identifies known and unknown clinically relevant genetic variants to help physicians achieve an accurate diagnosis.

Phase 2a Findings Demonstrate that CSL112, A Novel Apolipoprotein A-I Infusion Therapy, Has a Favorable Safety Profile, is Well Tolerated and Increases Cholesterol Efflux Capacity in Stable Atherothrombotic Patients
20 Nov 2013

Results of a Phase 2a trial of CSL112, sponsored by CSL Limited, demonstrated favorable safety and tolerability when administered to patients with stable atherothrombotic disease. The trial data for CSL112 also showed a dramatic and rapid increase in key biomarkers of reverse cholesterol transport, a process by which cholesterol is removed from arteries and transported to the liver for clearance.

International Survey Finds Self-Administered Treatment on the Rise Among Hereditary Angioedema Patients
08 Nov 2013

More patients with hereditary angioedema (HAE), a rare and potentially fatal genetic disorder, are being offered and opting for self-administration therapy, according to data from a new survey being presented at the 2013 American College of Allergy, Asthma & Immunology (ACAAI) Annual Meeting. Of the HAE treatment centers surveyed in Europe, Canada and the United States, the majority (70 percent) reported that at least 50 percent of patients were now self-administering their therapy, and the HAE specialists who responded agreed that this treatment option is advantageous to patients, citing key benefits as time saved, independence and convenience.

Plasma Donors Recognized For Their Lifesaving Contributions To The Treatment Of Rare Diseases
15 Oct 2013

CSL Plasma, operator of one of the largest plasma collection networks in the world and parent company CSL Behring celebrate the contributions of donor-heroes during International Plasma Awareness Week (IPAW), October 13–20. The week-long observance, which is sponsored by the Plasma Protein Therapeutics Association and its member-companies, raises global awareness of source plasma collection and increases understanding of plasma protein therapies and rare diseases.

CSL Behring Launches MySource™ at the National Hemophilia Foundation’s 65th Annual Meeting
03 Oct 2013

People who are living with a rare and serious bleeding disorder will now have one-stop access to educational resources, financial support, and community connection programs through CSL Behring’s MySource™ program. Launched during the National Hemophilia Foundation’s (NHF) 65th Annual Meeting, MySource allows patients, caregivers and healthcare professionals to quickly and easily access CSL Behring’s patient-support resources at one online location www.MySourceCSL.com or with a one-on-one care coordinator (at 1-800-676-4266).

CSL Behring Gains Approval to License Hizentra® in Japan for the Treatment of Primary Immunodeficiency and Secondary Immunodeficiency
27 Sep 2013

CSL Behring announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Hizentra® (Immune Globulin Subcutaneous [Human]) for the treatment of primary immunodeficiency (PID) and for the treatment of secondary immunodeficiency (SID). Hizentra is now the first and only 20 percent subcutaneous immunoglobulin (SCIg) therapy in the world for the treatment of these conditions, both of which belong to group of rare and serious diseases of the immune system. The Japanese MHLW approval marks the first time any SCIg therapy has been approved for use in Japan.

FDA Approves New Dosing Option for CSL Behring’s Hizentra®
27 Sep 2013

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has expanded the administration options for Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, to include dosing once every two weeks (biweekly) for people diagnosed with primary immunodeficiency (PI). Hizentra, the first and only 20 percent subcutaneous immunoglobulin, received FDA approval in March 2010 as a once weekly immunoglobulin G (IgG) replacement therapy. Self-administered weekly or biweekly, Hizentra delivers consistent levels of IgG to help protect those with PI against infections.

CSL Behring Announces FDA Approval of a 10 g (50 mL) Vial Size for Hizentra®
03 Sep 2013

CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved a 10 g (50 mL) vial size for Hizentra®, Immune Globulin Subcutaneous (Human). Hizentra, the first and only 20 percent subcutaneous immunoglobulin therapy, keeps serum immunoglobulin G (IgG) levels consistent week to week to help protect people with primary immunodeficiency (PI) against infections. The new vial size, 10 g (50 mL), will be available in the U.S. in October.

CMS Approves New Technology Add-On Payment for CSL Behring’s Kcentra™
12 Aug 2013

CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) has approved a new technology add-on payment (NTAP) for Kcentra™ (Prothrombin Complex Concentrate [Human]) for use in the inpatient hospital setting for the urgent reversal of warfarin therapy in adult patients with acute major bleeding. Kcentra, the first non-activated 4-factor prothrombin complex concentrate (4F-PCC), was approved by the U.S. Food and Drug Administration (FDA) in April 2013 for this use.

CSL Behring Presents Population Pharmacokinetic Model for Novel Recombinant Factor IX Hemophilia B Treatment That Supports Less Frequent Administration
03 Jul 2013

CSL Behring today presented a population pharmacokinetic model for recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam. The model confirms earlier results from the first-in-human dose escalation trial, which demonstrated improved pharmacokinetics of rIX-FP, with prolonged half-life compared to currently available factor IX.

International Trial Shows Clinical Efficacy of Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) for Once Weekly Prophylaxis in Patients with Severe Hemophilia B
03 Jul 2013

Data presented by CSL Behring today showed clinical efficacy of a once-weekly dosing regimen of recombinant fusion protein linking coagulation Factor IX with albumin (rIX-FP). Results of the study were presented during an oral session at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam.

CSL Behring Presents Phase I Results From Study of Recombinant Fusion Protein Linking Coagulation Factor VIIa with Albumin (rVIIa-FP) in Healthy Volunteers
03 Jul 2013

CSL Behring today presented Phase I data of their recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) in healthy volunteers at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam.

CSL Behring Announces Results from Study of Recombinant Single-Chain Factor VIII (rVIII-SingleChain) for Treatment of Hemophilia A
03 Jul 2013

CSL Behring today announced that pharmacokinetic results for its novel investigational recombinant coagulation single-chain factor VIII (rVIII-SingleChain) showed improved half-life over octocog alfa (the comparator). It also demonstrated a safety and efficacy profile that supports advancement to late-stage clinical development. The data were presented at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam.

CSL Behring to Premier Data from Broad Recombinant Clinical Development Program in Hemophilia at the International Society of Thrombosis and Haemostasis (ISTH) Congress
27 Jun 2013

CSL Behring today announced it will present study data from three ongoing clinical trial programs evaluating the Company’s novel recombinant factor VIIa (rVIIa-FP), VIII (rVIII-SingleChain) and IX (rIX-FP) agents for people with hemophilia A and B with and without inhibitors. The data will be presented at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam. CSL Behring is the only company pursuing longer-acting rVIIa-FP and rIX-FP candidates based on recombinant albumin, and a rVIII-SingleChain compound that has been shown to improve the stability and half-life of factor VIII (FVIII).

CSL Behring Doses First Patient in Part 3 of Global Phase I/III Pivotal Study of rVIII-SingleChain (Recombinant Single-Chain Factor VIII) for Treatment of Hemophilia A
04 Jun 2013

CSL Behring has dosed the first patient in Part 3 of its AFFINITY clinical trial program, which is now in phase III. AFFINITY is an open-label, non-randomized multi-center study evaluating the efficacy, safety and pharmacokinetics of its novel investigational recombinant coagulation single-chain factor VIII (rVIII-SingleChain) for the treatment of hemophilia A. The patient was dosed in Vienna, Austria and had a successful major surgery.

CSL Behring Doses First Patient in Part 3 of Global Phase I/III Pivotal Study of rVIII-SingleChain (Recombinant Single-Chain Factor VIII) for Treatment of Hemophilia A
04 Jun 2013

CSL Behring has dosed the first patient in Part 3 of its AFFINITY clinical trial program, which is now in phase III. AFFINITY is an open-label, non-randomized multi-center study evaluating the efficacy, safety and pharmacokinetics of its novel investigational recombinant coagulation single-chain factor VIII (rVIII-SingleChain) for the treatment of hemophilia A. The patient was dosed in Vienna, Austria and had a successful major surgery.

CSL Behring Receives FDA Approval of Kcentra™ for Urgent Warfarin Reversal in Patients with Acute Major Bleeding
29 Apr 2013

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) approved Kcentra™ (Prothrombin Complex Concentrate [Human]), the first non-activated 4-factor prothrombin complex concentrate (PCC) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (e.g., warfarin) therapy in adult patients with acute major bleeding. The pivotal clinical trial showed that Kcentra met all efficacy and safety endpoints, including the endpoints of hemostatic efficacy and International Normalized Ratio (INR) reduction compared with plasma, the most widely used agent for warfarin reversal in the United States.

CSL Behring Receives European Health Authorities’ Approval of Berinert® for Short-Term Prophylaxis in Adults and Children
16 Apr 2013

CSL Behring today announced that European health authorities have approved an extended use of Berinert®, a C1-esterase inhibitor (C1-INH) concentrate, for pre-procedure prevention (short-term prophylaxis) of acute episodes of hereditary angioedema (HAE), in adult and pediatric patients undergoing medical, dental or surgical procedures. HAE is a rare, serious and sometimes life-threatening genetic disorder.