Press Releases
25 June 2008
CSL Behring Awards LEAD Grants to Support Patient Group Advocacy Efforts
CSL Behring announced it has recently awarded seven grants totaling more than $90,000 to patient advocacy organizations in the United States. The seven grants represent the first round of awards in the company's Local Empowerment for Advocacy Development (LEAD) program. CSL Behring is a global leader in the plasma protein biotherapeutics industry. LEAD grants support grassroots advocacy efforts by organizations committed to helping people with rare diseases who use plasma-derived and recombinant therapies to manage their health conditions. CSL Behring awards LEAD grants semiannually.
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17 April 2008
CSL Behring Submits NDS to Health Canada Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema
CSL Behring has filed a new drug submission (NDS) with Health Canada seeking approval to market its C1-esterase inhibitor concentrate in Canada for the treatment of hereditary angioedema (HAE), a rare and serious genetic disorder. The submission is based on the recently completed phase II/III prospective, double-blind placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.), the largest HAE trial ever conducted, that studied the efficacy of pasteurized C1-INH concentrate.
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03 April 2008
CSL Behring Signs Agreements with Canadian Blood Services and Héma-Québec to Supply Life-Saving Therapies
CSL Behring Canada, Inc. today announced that Canadian Blood Services, and Héma-Québec, have each awarded the company contracts to supply Helixate
® FS ( Antihemophilic Factor [Recombinant]), Humate
® P (Antihemophilic factor / von Willebrand Factor Complex [Human], Dried, Pasteurized), Privigen (Immune Globulin Intravenous [Human]), Vivaglobin
® (Immune Globulin Subcutaneous [Human]) and other plasma-derived products. These products are used for the treatment of conditions such as hemophilia, von Willebrand Disease, primary immunodeficiency as well as other serious conditions.
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18 March 2008
C1-Esterase Inhibitor Concentrate Rapidly Relieves Abdominal and Facial Attacks in Patients with Hereditary Angioedema, According to Pivotal Study
C1-esterase inhibitor (C1-INH) concentrate is a safe and effective therapy that rapidly relieves acute abdominal and facial swelling attacks in patients with hereditary angioedema (HAE), a rare and serious genetic disorder, according to data presented today at the American Academy of Allergy, Asthma & Immunology (AAAAI) 64th Annual Meeting. Results from the prospective, double-blind International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T. 1), the largest HAE study ever conducted, showed patients receiving C1-INH concentrate had a median time to symptom relief of 30 minutes, versus 90 minutes for patients receiving placebo. Additionally, interim results from I.M.P.A.C.T. 2, also presented at AAAAI, demonstrated for the first time C1-INH replacement therapy’s effectiveness in rapidly relieving HAE attacks in peripheral body locations, such as the hands and feet.
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17 March 2008
L-Proline Stabilized Immune Globulin Intravenous (Human) 10% Liquid, Privigen™, Demonstrates Good Tolerability at High Infusion Rates
CSL Behring announced data today from a study that demonstrates its new liquid immune globulin intravenous (human) 10% product (Privigen™), is well-tolerated in patients with Primary Immune Deficiencies (PI); a group of predominantly genetic disorders that cause a malfunction in part or all of the immune system. New data from an additional study also showed that Privigen is well-tolerated when administered at high infusion rates. Both studies were presented at the American Academy of Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia, U.S.
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06 March 2008
CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema
CSL Behring has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval to market its C1-esterase inhibitor concentrate in the United States for the treatment of hereditary angioedema (HAE), a rare and serious genetic disorder. The submission is based on the recently completed phase II/III prospective, double-blind placebo-controlled
International
Multi-center
Prospective
Angioedema
C1-Inhibitor
Trial (I.M.P.A.C.T.), the largest HAE trial ever, that studied the efficacy of pasteurized C1-INH concentrate.
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29 February 2008
NHLBI Issues First U.S. von Willebrand Disease Clinical Practice Guidelines
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health, today issued the first clinical guidelines in the United States for the diagnosis and management of von Willebrand Disease (VWD), the most common inherited bleeding disorder. The guidelines include recommendations on screening, diagnosis, disease management, and directions for future research. An extensive article on the guidelines is published online Feb. 29 in the journal
Haemophilia.
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20 February 2008
CSL Behring Launches LEAD Program to Support Patient Group Advocacy Efforts
CSL Behring, a global leader in the plasma protein biotherapeutics industry, is launching a new program to support patient organizations’ grassroots advocacy efforts in the United States. Called Local Empowerment for Advocacy Development, or LEAD, the program will make grants available to groups of patients who have rare diseases and who use plasma-derived and recombinant therapies to manage their conditions. The program, which is the latest initiative in CSL Behring’s continued commitment to patient advocacy, includes two initiatives: LEAD Grants and Raise Your Voice!, a youth-focused advocacy training program.
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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.
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27 July 2007
CSL Behring Announces FDA Approval of PrivigenTM—First Proline-Stabilized 10 Percent Liquid IVIg
CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for PrivigenTM [Immune Globulin Intravenous (Human), 10% Liquid], an intravenous immunoglobulin (IVIg) for treating patients diagnosed with primary immunodeficiency (PI). Privigen is also indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) to rapidly raise platelet counts to prevent bleeding.
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13 July 2007
CSL Behring Completes Enrollment for Phase III Registration Trial of Next Generation of Subcutaneous Immunoglobulin
CSL Behring announced today that it has completed patient enrollment for a Phase III clinical trial of a 20 percent formulation of subcutaneous immunoglobulin (SCIg) to treat patients with primary immunodeficiency (PI) who require immune globulin replacement therapy. The study will assess the efficacy, tolerability, safety and pharmacokinetics of SCIg stabilized with proline (IgPro20) in subjects with PI. The open-label registration trial incorporates 13 sites across the United States, with 54 patients now enrolled.
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12 July 2007
CSL Behring completes enrollment for Phase III registration trial of next generation of subcutaneous immunoglobulin
CSL Behring announced today that it has completed patient enrollment for a Phase III clinical trial of a 20 percent formulation of subcutaneous immunoglobulin (SCIg) to treat patients with primary immune deficiency (PI) who require immunoglobulin replacement therapy. The study will assess the efficacy, tolerability, safety and pharmacokinetics of SCIg stabilized with proline (IgPro20) in subjects with PI. A multicenter, open-label, registration trial, the study incorporates 13 sites across the United States, with 54 patients now enrolled.
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10 July 2007
Beriplex® P/N Provides Fast, Predictable and Safe Anti-coagulation Reversal, According to Study
Beriplex
® P/N, a human prothrombin complex concentrate (PCC), is highly effective and safe in the emergency reversal of anti-coagulation, according to data presented today at the International Society on Thrombosis and Haemostasis (ISTH) XXIst Congress. The data showed Beriplex P/N rapidly and safely increases plasma levels of essential coagulation factors II, VII, IX, and X and anticoagulant inhibitors Protein C and Protein S prior to emergency interventions or to treat acute bleeding.
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09 July 2007
CSL Behring Makes Annual Start-Up Grants Available to Next Generation of Coagulation Researchers
CSL Behring, a global leader in the protein biotherapeutics industry, announced today at the International Society on Thrombosis and Haemostasis (ISTH) XXIst Congress that it will award five annual grants to support new research projects in the area of coagulation. The start-up grants of 20,000 euros each ($26,780 U.S) will be awarded to young medical researchers for preclinical and/or clinical coagulation projects based on the scientific merit of their work.
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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.
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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.
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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 Rh
0(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 Rh
0(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.
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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).
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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.
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