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2014 News Releases

2014 News Releases

CSL Behring Submits Biologics License Application for FDA Approval of Recombinant Fusion Protein Linking Coagulation Factor IX with Recombinant Albumin (rIX-FP) for Hemophilia B Patients

16 Dec 2014

CSL Behring announced today it has submitted a biologics license application (BLA) to the United States Food and Drug Administration (FDA) for the marketing authorization of its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). Once approved by the FDA, rIX-FP (Coagulation Factor IX {Recombinant}, Albumin Fusion Protein) will provide people with hemophilia B and their physicians a long-acting treatment option with dosing intervals up to 14 days.

One Woman's Story: Living and Helping Others with Inherited Lung Disorder

08 Dec 2014

Wheezing, shortness of breath and chronic bronchitis are often associated with asthma or chronic obstructive pulmonary disease (COPD). However, they are also symptoms of a serious genetic form of emphysema called Alpha-1 Antitrypsin Deficiency, also known as Alpha-1.

EMA Approves Amended Product Label for CSL Behring’s Hizentra®

04 Dec 2014

CSL Behring announced today that the European Medicines Agency (EMA) has approved the amended product labeling for Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid. The new label provides the ability to individualize treatment with flexible dosing – to administer Hizentra at intervals from daily to once every two weeks (biweekly).

CSL Issues “Our Corporate Responsibility 2014” Report

04 Dec 2014

CSL Behring’s parent company CSL Limited (ASX:CSL) has issued its annual corporate responsibility report – “Our Corporate Responsibility 2014.” The report details the global biopharmaceutical company’s performance across key priority areas from July 1, 2013 through June 30, 2014 – recording another strong performance led by CSL Behring.

CMS Extends New Technology Add-On Payment for CSL Behring’s Kcentra®

01 Dec 2014

CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) has extended the new technology add-on payment (NTAP) for Kcentra® (Prothrombin Complex Concentrate [Human]) through September 2015 for eligible Medicare beneficiaries treated in the inpatient hospital setting. Kcentra, the first and only non-activated 4-factor prothrombin complex concentrate (4F-PCC) approved by the U.S. Food and Drug Administration (FDA), is indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding or in need of an urgent surgery or invasive procedure. Kcentra, first approved for use in the U.S. in April 2013, received its NTAP designation effective October 1, 2013.

CSL112 Found to Elevate Cholesterol Efflux in Patients with Coronary Artery Disease and Mechanism for Rapid Cholesterol Efflux Capacity Demonstrated

18 Nov 2014

Two research studies presented today at the American Heart Association Scientific Sessions in Chicago provide further understanding of the mechanisms by which CSL112, a novel formulation of apolipoprotein A-1 (apoA-1), may reduce the high incidence of early recurrent cardiovascular events seen in post MI patients. Early recurrent cardiovascular events are associated with high morbidity and mortality, and reducing early events is an important target for new therapies.

CSL Limited Launches AEGIS-I, a Phase 2b Clinical Study of CSL112, a Novel Apolipoprotein A-I Infusion Therapy Designed to Rapidly Remove Cholesterol from Arteries and Stabilize Plaque

10 Nov 2014

CSL Limited today announced the launch of AEGIS-I, a Phase 2b clinical study of CSL112, a novel formulation of apolipoprotein A-I (apoA-I). Administered as a short series of weekly infusions, CSL112 is designed to rapidly remove cholesterol from the arteries and stabilize lesions at risk of rupture. This represents a new approach to reduce the high incidence of early recurrent cardiovascular events in the days and weeks following a heart attack.

Evidence presented at the 16th Biennial Meeting of the European Society for Immunodeficiencies (ESID) Supports Individualized Dosing with Hizentra®

30 Oct 2014

The goal of individualized therapy in the treatment of primary immunodeficiency (PI), a serious, life-threatening and lifelong condition, is to provide patients with the best clinical outcome. Individualized therapy is now possible thanks to recent advances in the field of IgG replacement therapy, which offer increased flexibility for physicians and patients.

CSL Behring Announces Winners of its 13th Annual Gettin’ in the Game Junior National Championship Program

29 Oct 2014

CSL Behring announced that William McCarthy from the Western Pennsylvania Chapter of the National Hemophilia Foundation and Nicholas Cleghorn from the Bleeding Disorders Advocacy Network are the national winners of the 2014 Gettin' in the GameSM Junior National Championship (JNC) program in golf and baseball, respectively. The JNC, launched in 2002, is CSL Behring’s annual baseball and golf competition that encourages kids to remain active despite the challenges a bleeding disorder can pose, while allowing them to develop life-long connections with other members of the community.

CSL Behring Signs Strategic Development Agreement with Enable Injections to Market Novel New Drug Delivery Device

28 Oct 2014

CSL Behring announced today that its affiliate company, CSL Behring AG, of Bern, Switzerland and Enable Injections, LLC, of Franklin, Ohio have signed a long-term development agreement for a new and innovative drug delivery system intended to improve the comfort, convenience and treatment compliance for patients with rare and serious diseases.

Plasma Donors Recognized During International Plasma Awareness Week for Helping Save Lives

13 Oct 2014

CSL Behring and its subsidiary, CSL Plasma, join the Plasma Protein Therapeutics Association (PPTA) in saluting the contributions of plasma donors during International Plasma Awareness Week (IPAW), celebrated October 12-18.

CSL Behring Launches $450 Million Capacity Expansion to Meet Growing Need for Lifesaving, Life-Improving Therapies

08 Oct 2014

CSL Behring today announced a multi-year, $450 million two-site global capacity expansion – the latest in a series of recent production expansions to meet the growing need for its lifesaving and life-improving therapies that are used to treat patients with rare and serious medical disorders around the world.

CSL Behring Expands Manufacturing Facility in Kankakee, Illinois to Meet Patients' Growing Needs

01 Oct 2014

CSL Behring announced that it is set to commence operations in its newly expanded facility now that the U.S. Food & Drug Administration (FDA) has granted approval. The expansion significantly increases plasma processing and albumin production capacity in the Kankakee, Ill. facility.

CSL Behring Announces Last Patient Treated in Phase III Study of Fibrinogen Concentrate to Control Bleeding During Aortic Aneurysm Surgery

16 Sep 2014

CSL Behring announced today that the last patient has been treated as part of the REPLACE (Randomized Evaluation of fibrinogen versus PLACEbo in complex cardiovascular surgery) Phase III clinical trial. REPLACE is the first randomized, double blinded, placebo-controlled, multicenter study in a large population of patients evaluating fibrinogen concentrate (Human) (FCH) in controlling bleeding during aortic aneurysm surgery.

Early Diagnosis of Children with Primary Immunodeficiencies Focus of National Awareness Campaign for School Nurses

18 Aug 2014

School nurses reach 98 percent of the 50,000,000 students in U.S. public schools, grades k-12, and are uniquely positioned to facilitate the early diagnosis of serious medical conditions such as primary immunodeficiency (PI).

Study Suggests C1-INH May Aid in Prevention of Antibody-Mediated Rejection Following Kidney Transplant

30 Jul 2014

A study presented at the 2014 World Transplant Congress evaluated the safety and efficacy of CSL Behring’s C1 Inhibitor (C1-INH) concentrate in preventing antibody-mediated rejection following kidney transplants in highly sensitized patients. C1-INH is a human protein and an important inhibitor of the complement system.

CSL Behring Announces the 2014 Interlaken Leadership Awards Recipient

24 Jun 2014

CSL Behring announced today that Bart C. Jacobs, M.D., Ph.D., Erasmus University Medical Center, Rotterdam, Netherlands, is the recipient of the 2014 Interlaken Leadership Awards for original research in the field of neuroimmunology. Established in 2010, this annual global awards program provides monetary grants and/or product supply for investigational use to researchers whose proposals are likely to advance innovative medical research and knowledge about the potential role of immunoglobulin (Ig) therapy in the treatment of neurological disorders.

CSL Behring Launches Hizentra® Co-Pay Relief Program

20 May 2014

People managing primary immunodeficiency (PI) with CSL Behring’s Hizentra® (Immune Globulin Subcutaneous [Human]) may now be eligible for financial support through the Hizentra® Co-Pay Relief Program. The new program offers eligible U.S. patients up to $4,000 per year to be applied toward Hizentra co-payments, deductibles and coinsurance. Out-of-pocket therapy costs will be processed seamlessly through the electronic billing systems of specialty pharmacies and physician offices, which means no paperwork is required for the patient, pharmacist or physician.

CSL Behring Proudly Supports HAE Day with Global Partnerships, Donations and Hereditary Angioedema Awareness Events

14 May 2014

As a Diamond Sponsor of HAE Day on May 16, 2014, CSL Behring is proud to continue its partnership with HAEi, the International Patient Organization for C1 Inhibitor Deficiencies, and patient organizations throughout the world. HAE, or, hereditary angioedema, is a rare, potentially fatal swelling disorder caused by a deficiency of C1-INH, a type of protein.

New Findings Support Less Frequent Dosing in Hemophilia B Patients Treated with Coagulation Factor IX with Recombinant Albumin (rIX-FP)

12 May 2014

Interim Phase II/III and III findings presented today by CSL Behring at the World Federation of Hemophilia (WFH) 2014 Congress demonstrate an improved pharmacokinetic (PK) profile of recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP) among hemophilia B patients of all age groups. These findings suggest an improvement in hemophilia B treatment by allowing a prolonged routine prophylaxis treatment interval of 14 days or potentially longer, compared to the current standard of two to three times per week. Data were presented during an oral session at the WFH Congress in Melbourne, Australia. CSL Behring is a subsidiary of CSL Limited (CSL: ASX), a biopharmaceutical company with headquarters in Melbourne, Australia.