LACHEN, Zwitserland – (BUSINESS WIRE) – Octapharma heeft vandaag aangekondigd dat nieuwe onderzoeksresultaten uit haar hematologieportfolio zullen worden gepresenteerd op het aanstaande International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress, dat plaatsvindt van 12 tot en met 14 juli 2020.

Het NuProtect-onderzoek (NCT01712438) onderzocht de immunogeniciteit, werkzaamheid en veiligheid van Nuwiq® (simoctocog alfa) bij 108 niet eerder behandelde patiënten met hemofilie A. De uiteindelijke resultaten van het onderzoek lieten een cumulatieve incidentie zien van hoge-titer anti-FVIII-remmers van 17,6%. Patiënten die het NuProtect-onderzoek voltooiden, kregen deelname aangeboden aan een langdurig verlengingsonderzoek (NCT01992549). De resultaten van het uitbreidingsonderzoek worden voor het eerst gepresenteerd op ISTH 2020.

Bij patiënten die remmers ontwikkelen, is immune tolerance induction (ITI) bij herhaalde toediening van FVIII de enige bewezen aanpak om remmers uit te roeien. Tijdens ISTH 2020 zullen drie posters worden gepresenteerd waarin wordt gerapporteerd over het succes van ITI met twee van Octapharma’s FVIII-producten, octanate® en Nuwiq®.

Hieronder vindt u de titels van de posters. Alle abstracts zijn beschikbaar op de ISTH-website.

New Data to Be Presented at the ISTH 2020 Virtual Congress Demonstrating Octapharma’s Commitment to Patients With Bleeding Disorders

LACHEN, Switzerland–(BUSINESS WIRE)– Octapharma announced today that new research findings from its haematology portfolio will be presented at the upcoming International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress, taking place on 12–14 July 2020.

The NuProtect study (NCT01712438) investigated the immunogenicity, efficacy and safety of Nuwiq^® (simoctocog alfa) in 108 previously untreated patients with haemophilia A. The final results of the study showed a cumulative incidence of high-titre anti-FVIII inhibitors of 17.6%. Patients who completed the NuProtect study were offered participation in a long-term extension study (NCT01992549). The results of the extension study will be presented for the first time at ISTH 2020.

In patients who develop inhibitors, immune tolerance induction (ITI) with repeated FVIII administration is the only proven approach to eradicate inhibitors. Three posters will be presented at ISTH 2020 reporting on the success of ITI with two of Octapharma’s FVIII products, octanate^® and Nuwiq^®.

The titles of the posters are provided below. All abstracts are available on the ISTH website.

Poster PB0999 Long-term immunogenicity, efficacy and safety of simoctocog alfa in patients with severe haemophilia A who had completed the NuProtect PUP study

Poster PB1001 Immune tolerance induction (ITI) with a single factor VIII/von Willebrand factor concentrate in haemophilia A patients with inhibitors – Update from the ObsITI Study

Poster PB1044 Immune tolerance induction with octanate^® in patients with haemophilia A and inhibitors: An ongoing case series from a Malaysian centre

Poster PB1047 Immune tolerance induction with simoctocog alfa in patients with haemophilia A: An ongoing multicentre case series from the UK

Octapharma will be sponsoring two scientific symposia at ISTH 2020 on haemophilia A and von Willebrand disease (VWD). The haemophilia A symposium will include new clinical and real-world data on Nuwiq^®, including final results from the NuProtect study and its long-term extension as well as experience with personalized prophylaxis in previously treated patients. New studies of ITI and the relevance of FVIII in managing joint and bone health will also be discussed. The VWD symposium will address the challenges of diagnosing VWD and particular issues facing women with VWD, as well as discussing the use of wilate^® for prophylaxis and during surgery.

Both symposia will be held on Tuesday 14 July (8:45 am EDT and 10:15 am EDT) on the ISTH virtual congress platform and will be freely available to all healthcare professionals. The symposia will remain on the congress platform for 90 days and be available on the ISTH Academy website for one year.

“We are very pleased to share the positive data across our product portfolio addressing the needs of individuals with haemophilia and von Willebrand disease”, said Dr Larisa Belyanskaya, Head of IBU Haematology at Octapharma. Olaf Walter, Board Member at Octapharma, added that “the data cover the large spectrum of care required by patients with coagulation disorders, and demonstrate Octapharma’s commitment to improving patients’ lives at an individual level.”

About Octapharma

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than 10,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Haematology, Immunotherapy, and Critical Care.

Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, with a combined capacity of approximately 8 million litres of plasma per annum. In addition, Octapharma operates more than 140 plasma donation centres across Europe and the US. More information on www.octapharma.com

About Nuwiq^®

Nuwiq^® (simoctocog alfa) is a 4th generation recombinant factor VIII (rFVIII) protein, produced in a human cell line without chemical modification or fusion with any other protein¹. It is cultured without additives of human or animal origin, is devoid of antigenic non-human protein epitopes and has a high affinity for von Willebrand factor¹. Nuwiq^® treatment has been assessed in seven completed clinical trials which included 201 previously treated patients (PTPs; 190 individuals) with severe haemophilia A, including 59 children¹. Nuwiq^® is available in 250 IU, 500 IU, 1000 IU, 2000 IU, 2500 IU, 3000 IU and 4000 IU presentations². Nuwiq^® is approved for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital FVIII deficiency) across all age groups².

1. Lissitchkov T et al. Ther Adv Hematol 2019; doi: 10.1177/2040620719858471.
2. Nuwiq^® Summary of Product Characteristics.

About wilate^®

wilate^® is a high-purity human von Willebrand factor/factor VIII (VWF/FVIII) concentrate, that undergoes two virus inactivation steps during its production.1 No albumin is added as a stabiliser¹. The purification processes result in a 1:1 ratio of VWF to FVIII that is similar to normal plasma¹. wilate^® contains a VWF triplet structure and content of large high molecular weight multimers similar to normal human plasma¹. wilate^® is exclusively derived from large pools of human plasma collected in approved plasma donation centres². wilate^® is available in 500 IU and 1000 IU presentations. wilate^® is indicated for the prevention and treatment of haemorrhage or surgical bleeding in von Willebrand disease (VWD), when desmopressin (DDAVP) alone is ineffective or contra-indicated, and for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) ².

1. Stadler M et al. Biologicals 2006; 34:281-8.
2. wilate^® Summary of Product Characteristics.

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Contacts

Macarena Guillamon

corporatecommunications@octapharma.com
Phone: +41 055 451 21 21