CSL Behring Delivers on its Promise to Advance Bleeding Disorder Treatment Research by Supporting 16 Data Presentations at ISTH 2019

Novel real world evidence for AFSTYLA® and IDELVION® to be highlighted

MELBOURNE, Australia, July 2, 2019 /PRNewswire/ -- Global biotherapeutics leader CSL Behring announced today that the company will support the presentation of new data from its recombinant coagulation factor programs at this year's International Society on Thrombosis and Haemostasis (ISTH) Congress in Melbourne, Australia, 6-10, July, 2019.  In addition to supporting 15 posters and one oral presentation, the company will also host two satellite symposiums during the meeting.  The ISTH congress presents an opportunity for leaders in hematology and thrombosis research to exchange new findings and discuss advances in patient care. 

"Real world evidence can provide deep new insights that complement data acquired in clinical trials and can unlock the promise of novel bleeding disorder treatments", said Andrew Cuthbertson, Chief Scientific Officer and R&D Director, CSL Limited. "These presentations demonstrate our commitment to improving treatments and will provide valuable understanding to patients and physicians when creating a care plan."

Seven poster presentations, an oral presentation and a satellite symposium will add to the growing body of evidence demonstrating the safety and efficacy of AFSTYLA® [Antihemophilic Factor (Recombinant), Single Chain]. AFSTYLA (also known as rVIII-SingleChain), CSL Behring's recombinant factor VIII single-chain therapy for haemophilia A, is approved in over 40 countries including Australia, Japan, the European Union, United States, and Switzerland.

Five posters and a satellite symposium will highlight new IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein] data. IDELVION (also known as rIX-FP), CSL Behring's long-acting recombinant factor IX albumin fusion protein for haemophilia B, is approved in over 40 countries including Australia, Japan, the European Union, United States and Switzerland.

Real World Evidence Posters:

• Real-world use of recombinant factor IX albumin fusion protein (rIX-FP) in patients with hemophilia B: A multinational prospective, non-interventional, post-marketing surveillance study (Johannes Oldenburg) – PB0281 [7 July, 18:30 - 19:30]

• Comparison of FVIII prophylaxis treatment regimen and associated clinical outcomes between rVIII-SingleChain and other rFVIII products commonly used in German Hemophilia A patients (Songkai Yan)  – PB0282 [7 July, 18:30 - 19:30]

• Real-world utilization and bleed rates in patients with hemophilia B who switched to recombinant factor IX fusion protein (rIX-FP) in Italy, Belgium and the United (Patrick Sommerer) – PB0691 [8 July, 18:30 - 19:30]

• Real-World Consumption rVIII-SingleChain: US Population Experience (Michael Wang) – PB0699 [8 July, 18:30 - 19:30]

• Prophylactic Factor VIII use and clinical outcomes in German Hemophilia A patients who switched to extended dosing intervals with long-acting rVIII-SingleChain (Songkai Yan) – PB0733 [8 July, 18:30 - 19:30]

• Analysis of recombinant FVIII consumption and treatment outcomes and comparison with other FVIII products based on US Hemophilia A prophylaxis patient charts (Songkai Yan) – PB1456 [9 July, 18:30 - 19:30]

Research Posters:

• Determining the Specificity of Commercially Available Thrombin Substrates (S. Praporski) - PB0111 [7 July, 18:30 - 19:30]

• Mechanisms for the Clearance and Recycling of Recombinant VWF D'D3 Albumin Fusion Protein (Kim Lieu)  PB0071 [7 July, 18:30 - 19:30]

• Efficacy and safety of rIX-FP in surgery: an update from a phase 3b extension study (Claude Négrier) – PB0734 [8 July, 18:30 - 19:30]

• Population Pharmacokinetics of rVIII-SingleChain in Obese Previously Treated Patients with Severe Hemophilia A in Study CSL627_1001 (William McKeand) – PB0709 [08.07.19, 18:30-19:30]

• Higher trough levels, improved quality of life and reduced costs when switching to rIX-FP in a severe hemophilia B patient with considerable neurological disability (Rosario Maggiore) – PB0684 [8 July, 18:30 - 19:30]

• Systematic review of efficacy and factor consumption of long-acting recombinant factor VIII products for prophylactic treatment of hemophilia A (Songkai Yan) – PB0730 [8 July, 18:30 - 19:30]

• Treatment Success of rVIII-SingleChain in Obese Previously Treated Patients with Severe Hemophilia A in study CSL627_1001 (Johnny Mahlangu) – PB1455 [9 July, 18:30 - 19:30]

• Long-term efficacy and safety of recombinant factor IX fusion protein (rIX-FP) in previously treated patients with hemophilia B: Results from a phase 3b extension study (Maria Elisa Mancuso) – PB1453 [9 July, 18:30 - 19:30]

• The Role of HLA-class-II (HLAcII) Molecules in Determining the Immunogenicity Potential of Therapeutic Factor VIII Proteins (tFVIIIs) in Hemophilia A (HA): The Gate Keeper Hypothesis (Vincent Diego) – PB1183 [9 July, 18:30 - 19:30]

Oral Presentation:

• Factor VIII (FVIII)-Haplotype Mismatch Increases Risk of Inhibitor Development in the Treatment of Hemophilia A (Tom Howard) – OC76.5 [10 July, 11:15 - 11:30 Meeting Room 219/220]

Symposia:

• Taking a Flexible Approach in Hemophilia B – Sunday, 7 July, 13:15-14:30 Meeting Room 212/213

• Improving Outcomes in Hemophilia A – Tuesday, 9 July, 13:15-14:30 Meeting Room 212/213

In addition, CSL Behring representatives will be available in the exhibition hall (booth numbers 701 & 800) throughout the congress.  The exhibit will highlight CSL Behring's 30 years of experience and broad portfolio of treatment options for patients living with inherited and acquired bleeding disorders.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients' needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL;USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 22,000 people, and delivers its life-saving therapies to people in more than 60 countries. For inspiring stories about the promise of biotechnology, visit Vita CSLBehring.com/vita and follow us on Twitter.com/CSLBehring.