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New Data for Two Leading Haemophilia Medicines -- AFSTYLA® and IDELVION® -- to be Presented at the International Society on Thrombosis and Haemostasis Congress 2017

New findings demonstrate CSL Behring’s promise to develop and deliver innovative treatments that improve patients’ lives

MARBURG, Germany. — 06 July 2017

CSL Behring announced today that it will present new data from its recombinant coagulation factor development programs at the International Society on Thrombosis and Haemostasis (ISTH) Congress 2017 in Berlin, Germany, July 8 – 13, 2017.

Six poster presentations 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 novel recombinant factor VIII single-chain therapy for haemophilia A, is approved in the European Union, United States, Canada, Switzerland and Australia.

Seven 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 novel, long-acting recombinant factor IX albumin fusion protein for haemophilia B, is approved in the European Union, United States, Canada, Switzerland, Australia and Japan.

Haemophilia is an inherited bleeding disorder caused by deficient or defective proteins that prevent the blood from clotting properly. Patients with haemophilia may experience acute and chronic traumatic or spontaneous bleeding, especially into the muscles, joints or internal organs. According to the World Federation of Hemophilia, the condition affects 1 in 10,000 people, most of whom have haemophilia A.

“Our presence at this year’s ISTH Congress will be one of the largest to-date focusing on new clinical findings for AFSTYLA and IDELVION,” said Dr. Andrew Cuthbertson, Chief Scientific Officer and Director of R&D, CSL Behring. “As a part of our promise to develop and reliably deliver safe, effective therapies that improve patients’ lives, we’re excited to share new findings showing the safety, efficacy and other related benefits of these novel recombinant therapies.”

Additional presentations and symposia will discuss the company’s investigational recombinant VWF D'D3 albumin fusion protein (rD'D3-FP) for haemophilia A, the long-acting fusion protein linking recombinant coagulation factor VIIa with recombinant albumin (rVIIa-FP) for haemophilia A or B with inhibitors, and a 4 factor prothrombin complex concentrate (4F-PCC) to reverse the effects of warfarin.

CSL Behring representatives will be available at booth number 420 in the CityCube Berlin Messe throughout the congress. Key sessions from CSL Behring at ISTH include:

AFSTYLA

Satellite Symposium
Tuesday, July 11, 1:15 p.m. – 2:30 p.m. CEST
Reach high in Haemophilia A: Treatment with AFSTYLA. Room Budapest

Poster Presentations
Monday, July 10, 12:00 p.m. - 1:15 p.m. CEST

  • Magnitude of dosing adjustment of AFSTYLA in clinical trials. Poster #239.
  • Projecting product consumption of AFSTYLA vs. octocog alfa in the United States. Poster #253.

Tuesday, July 11, 12:00 p.m. - 1:15 p.m. CEST

  • Dosing of rVIII-SingleChain based on clinical bleeding phenotypes results in low bleeding rates in paediatric patients treated with prophylaxis two or three times weekly. Poster #953.
  • rVIII-SingleChain in surgical prophylaxis: Efficacy and safety in 35 surgeries. Poster #965.
  • Analysis of the novel recombinant Factor VIII‐SingleChain protein predicts a lower immunogenic potential as compared to full‐length recombinant FVIII. Poster #1121.

Wednesday, July 12, from 12:00 p.m. - 1:15 p.m. CEST

  • Efficacy of rVIII-SingleChain in the treatment of adult and adolescent patients with severe haemophilia A in Europe. Poster #1791.

IDELVION

Satellite Symposium
Wednesday, July 12, 1:15 – 2:30 pm CEST
IDELVION: A gold standard in the treatment of Haemophilia B? Room Paris

Poster Presentations
Monday, July 10, 12:00 p.m. - 1:15 p.m. CEST

  • Differential investigation of post‐translational modifications in recombinant and plasma‐derived human coagulation FIX. Poster #121.


Tuesday, July 11, 12:00 p.m. - 1:15 p.m. CEST

  • Prophylaxis with rIX-FP reduces consumption compared with previous FIX in both adult and paediatric patients. Poster #952.
  • Health-related quality of life in paediatric haemophilia B patients treated with rIX-FP. Poster #1105.
  • Clinically-relevant bioavailability of rIX-FP after subcutaneous administration to rodent and non-rodent species. Poster #1114.
  • Extended haemostatic efficacy of rIX-FP is confirmed in a haemophilia B mouse model of arterial injury. Poster #1130.


Wednesday, July 12, 12:00 p.m. - 1:15 p.m. CEST

  • High adherence in adult and paediatric patients with haemophilia B receiving prophylaxis with rIX-FP. Poster #1816.
  • High and sustained observed trough FIX activity levels with prophylactic dosing of IDELVION (rFIX-FP) in patients with haemophilia B. Poster #1772.

rD’D3-FP

Oral Presentations
Monday, July 10, 9:30 a.m. – 10:45 a.m. CEST Session Room: Helsinki 2

  • FcRn mediated recycling of recombinant VWF D'D3‐albumin fusion protein / rVIII‐SingleChain complex is a mechanism for FVIII half‐life extension Oral #10.4
  • Half-life extension of FVIII by co-administration of a recombinant D’D3 albumin fusion protein Oral #10.5

Poster Presentations
Tuesday, July 11, 12:00 p.m. - 1:15 p.m. CEST

  • Identification of amino acid substitutions in the D’D3 region of von Willebrand Factor that increase the binding affinity for FVIII. Poster #1122.

rVIIa-FP

Poster Presentations
Tuesday, July 11, 12:00 p.m. - 1:15 p.m. CEST

  • Pharmacokinetics of recombinant fusion protein linking activated factor VIIa to human albumin (rVIIa-FP), eptacog alfa and plasma-derived factor VII in patients with congenital FVII deficiency. Poster #944.
  • Pharmacodynamic efficacy of a recombinant fusion protein linking activated factor VIIa to human albumin (rVIIa-FP) in FVII depleted plasma Poster #1129.
  • Pharmacodynamic efficacy of a recombinant fusion protein linking activated factor VIIa to human albumin (rVIIa-FP) in FVIII and FIX depleted plasma with or without inhibitors. Poster #1126.
  • Recombinant factor VIIa-albumin fusion protein undergoes Endothelial Cell Protein C Receptor mediated internalization and recycling. Poster #1112.

Wednesday, July 12, 12:00 p.m. – 1:15 p.m. CEST

  • Pharmacokinetics of recombinant fusion protein linking activated factor VIIa to human albumin (rVIIa-FP) and eptacog alfa in haemophilia patients with inhibitors. Poster #1773.

4F-PCC

Satellite Symposium
Sunday, July 9, 4:15 p.m. – 5:45 p.m. CEST
Management of bleeding in anticoagulated patients Room A3

Poster Presentations
Monday, July 10, 12:00 p.m. - 1:15 p.m. CEST

  • Favorable thrombogenicity profile of a Prothrombin Complex Concentrate (4F-PCC) in animal models of venous and arterial thrombosis. Poster #340.

About CSL Behring

CSL Behring is a global biotherapeutics leader which is driven by its promise to serve 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), headquartered in Melbourne, Australia, employs nearly 20,000 people, delivering its life-saving therapies to people in more than 60 countries. For more information visit www.CSLBehring.com and follow us on www.Twitter.com/CSLBehring.

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Media Contact:

Greg Healy
CSL Behring
Office: +1 610-878-4841
Mobile: +1 610-906-4564
Email: Greg.Healy@cslbehring.com

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