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November 27, 2015 10:46 AM ET


Company Overview of CSL Behring LLC

Company Overview

CSL Behring LLC, a biopharmaceutical company, engages in the research, development, manufacture, and marketing of protein-based therapies for the treatment of serious and rare conditions worldwide. It offers bleeding disorder, fluid replacement, hereditary angioedema, immunoglobulin, pulmonary, and wound healing biotherapies. The company also operates a plasma collection network. Its therapies are indicated for the treatment of coagulation disorders, including hemophilia and von Willebrand disease; primary immune deficiencies; neurological conditions; inherited respiratory diseases; hereditary angioedema; and cardiac surgery, organ transplantation, burn treatment, and hemolytic disease preve...

1020 First Avenue

P.O. Box 61501

King of Prussia, PA 19406-0901

United States

Founded in 2000





Key Executives for CSL Behring LLC

Chief Executive Officer and Managing Director
Age: 58
Chief Financial Officer and Senior Vice President of Research & Development
Age: 52
Executive Vice President of Global Commercial Operations
Age: 56
Chief Scientific Officer and R&D Director
Age: 60
Executive Vice President of Legal and General Counsel
Age: 54
Compensation as of Fiscal Year 2015.

CSL Behring LLC Key Developments

CSL Behring Enrolls First Patient in Global Phase II/III Study of rVIIa-FP for On-Demand Treatment of Patients with Hemophilia A or B with Inhibitors

CSL Behring announced that the first patient has been enrolled in its Phase II/III clinical study evaluating the pharmacokinetics (PK), efficacy, and safety of the company's recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) for on-demand treatment in patients with congenital hemophilia A or B who have developed an inhibitor to factor VIII or factor IX replacement therapy. The study will enroll approximately 54 male patients, the first of whom was enrolled in Malaysia. This Phase II/III study in patients with hemophilia A or B who have developed an inhibitor is a part of the PROLONG-7FP clinical development program. This program aims to demonstrate the therapeutic advantages of rVIIa-FP in patients with hemophilia A or hemophilia B who have developed inhibitors as well as in patients with congenital FVII deficiency. A Phase I PK study in patients with congenital FVII deficiency is ongoing.

Swissmedic Accepts for Review CSL Behring's MAA for rIX-FP for Patients with Hemophilia B

CSL Behring announced that Swissmedic has accepted for review a Marketing Authorization Application (MAA) for the company's investigational long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP) for the prophylaxis and treatment of bleeding episodes in people with Hemophilia B. Upon Swissmedic approval, rIX-FP will provide hemophilia B patients with a long-acting treatment option with dosing intervals up to 14 days. Hemophilia B is a congenital bleeding disorder characterized by deficient or defective factor IX. It affects approximately 1 in 25,000 to 50,000 people. Nearly all patients are male. The submission is based on the PROLONG-9FP clinical development program. PROLONG-9FP includes Phase I through Phase III open-label, multicenter studies evaluating the safety and efficacy of rIX-FP in adults and children (ages 1 to 61 years) with hemophilia B who were previously treated with other factor IX products. Results from the Phase III studies were recently presented at the 2015 International Society on Thrombosis and Haemostasis (ISTH) Congress in Toronto. The data showed median annualized spontaneous bleeding rates (AsBR) of 0.00 in patients using rIX-FP prophylactically once every 7 days (age 1-11 years) and once up to every 14 days (age 12-61 years). The data also showed that 97% (age 1-11 years) and 99% (age 12-61 years) of bleeding events were treated with one or two infusions, with the majority of events (89% in patients 1-11 years, and 94% in patients 12-61 years) treated with only one infusion. Across the Phase III studies, none of the patients developed inhibitors to factor IX or antibodies to rIX-FP. The most common adverse reaction in clinical trials was headache.

CSL Behring Approves Health Canada for the Treatment of Hereditary Angioedema

CSL Behring announced that Health Canada has approved a new, low-volume presentation size for the existing indications of Berinert®, a human plasma-derived, pasteurized and nanofiltered C1-esterase inhibitor (C1-INH) concentrate. The new Berinert® 1500 IU format is reconstituted with 3 mL vial of Sterile Water for Injection (Diluent). In Canada, Berinert® is indicated for the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) of moderate to severe intensity. Berinert®, licensed since 2010, is the first C1-INH available in Canada. The new vial size with 1500 International Units of C1-esterase inhibitor can be prepared and administered faster than the same dose using the existing vial size of 500 IU. This is particularly significant for patients who weigh more than 50 kilograms. In the past, these patients had to mix three different vials of C1-esterase inhibitor before administration. This new concentrated formulation allows patients over 50 kilograms to mix and administer just one vial.

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