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

MELBOURNE, Australia, July 1, 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 Rom 212/213

• Improving Outcomes in Hemophilia A – Tuesday, 9 July, 13:15-14:30 Meeting Rom 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.

AFSTYLA^® Important Safety Information

AFSTYLA®, Antihemophilic Factor (Recombinant), Single Chain, is used to treat and control bleeding episodes in people with hemophilia A. Used regularly (prophylaxis), AFSTYLA can reduce the number of bleeding episodes and the risk of joint damage due to bleeding. Your doctor might also give you AFSTYLA before surgical procedures.

AFSTYLA is administered by intravenous injection into the bloodstream, and can be self-administered or administered by a caregiver. Your healthcare provider or hemophilia treatment center will instruct you on how to do an infusion. Carefully follow prescriber instructions regarding dose and infusion schedule, which are based on your weight and the severity of your condition.

Do not use AFSTYLA if you know you are allergic to any of its ingredients, or to hamster proteins. Tell your healthcare provider if you previously had an allergic reaction to any product containing Factor VIII (FVIII), or have been told you have inhibitors to FVIII, as AFSTYLA might not work for you. Inform your healthcare provider of all medical conditions and problems you have, as well as all medications you are taking.

Immediately stop treatment and contact your healthcare provider if you see signs of an allergic reaction, including a rash or hives, itching, tightness of chest or throat, difficulty breathing, lightheadedness, dizziness, nausea, or a decrease in blood pressure.

Your body can make antibodies, called inhibitors, against FVIII, which could stop AFSTYLA from working properly. You might need to be tested for inhibitors from time to time. Contact your healthcare provider if bleeding does not stop after taking AFSTYLA.

In clinical trials, dizziness and allergic reactions were the most common side effects. However, these are not the only side effects possible. Tell your healthcare provider about any side effect that bothers you or does not go away.

Please see full prescribing information for AFSTYLA, including patient product information.

IDELVION^® Important Safety Information

IDELVION®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rFIX-FP), is used to control and prevent bleeding episodes in people with hemophilia B. Your doctor might also give you IDELVION before surgical procedures. Used regularly as prophylaxis, IDELVION can reduce number of bleeding episodes.

IDELVION is administered by intravenous injection into the bloodstream, and can be self-administered or administered by a caregiver. Do not inject IDELVION without training and approval from your healthcare provider or hemophilia treatment center.

Tell your healthcare provider of any medical condition you might have, including allergies and pregnancy, as well as all medications you are taking. Do not use IDELVION if you know you are allergic to any of its ingredients, including hamster proteins. Tell your doctor if you previously had an allergic reaction to any FIX product.

Stop treatment and immediately contact your healthcare provider if you see signs of an allergic reaction, including a rash or hives, itching, tightness of chest or throat, difficulty breathing, lightheadedness, dizziness, nausea, or a decrease in blood pressure.

Your body can make antibodies, called inhibitors, against Factor IX, which could stop IDELVION from working properly. You might need to be tested for inhibitors from time to time. IDELVION might also increase the risk of abnormal blood clots in your body, especially if you have risk factors. Call your healthcare provider if you have chest pain, difficulty breathing, or leg tenderness or swelling.

In clinical trials for IDELVION, headache was the only side effect occurring in more than 1% of patients (1.8%), but is not the only side effect possible. Tell your healthcare provider about any side effect that bothers you or does not go away, or if bleeding is not controlled with IDELVION.

Please see full US prescribing information for IDELVION, including patient product information.

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.

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