PR96842

LACHEN, Switzerland, July 4, 2022 /PRNewswire=KYODO JBN/--

- Octapharma to present new clinical and scientific data from across

Octapharma's haematology and critical care portfolios during the ISTH 2022

Congress

- Data to be presented in 11 poster presentations and during two Supported

Symposia

- New data from the extensive clinical trial programme with Nuwiq(R)

(simoctocog alfa) to be presented, confirming Nuwiq(R)'s efficacy and safety

profile

The latest developments in Octapharma's haematology and critical care

portfolios will be presented at the 30th International Society on Thrombosis

and Haemostasis (ISTH) Congress on July 9–13, 2022, in London, UK. The data

will be featured in eleven poster presentations and two Supported Symposia

during this major international meeting. Octapharma is proud to be a Gold

Supporter of the ISTH 2022 Congress.

Poster presentations at the Congress will include data from the Nuwiq(R)

clinical trial programme, including a pooled analysis of long-term data from

clinical trials and the first presentation of the results of the global GENA-99

study of Nuwiq in real-world clinical practice. These studies confirm the

proven efficacy and safety profile of Nuwiq(R) in patients with haemophilia A.

The safety and immunogenicity results from the phase I/II study of OCTA101, a

recombinant FVIII developed for subcutaneous administration, will also be

presented, following the recent decision to terminate the study due to safety

concerns. Updates from the clinical development programme with the four-factor

prothrombin complex concentrate Octaplex(R) and the high-purity, double virus

inactivated, lyophilized human antithrombin III concentrate Atenativ(R) will

also be provided, demonstrating Octapharma's commitment to clinical research

and development in critical care.

The following posters will be presented.

Monday July 11, 18:30–19:30

- PB0690. Dose optimisation in children with severe haemophilia A on long-term

octanate(R) prophylaxis. Presenting Author: Evgeny Dmitriev

- PB0672. Safety and pharmacokinetics of a subcutaneous recombinant FVIII

(OCTA101) in adult patients with severe haemophilia A. Presenting Author:

Sigurd Knaub

- PB0559. LEX-210: a phase 3, randomized, double-blinded study of four-factor

prothrombin complex concentrate in patients with acute major bleeding on direct

oral anticoagulant therapy with factor Xa inhibitors. Presenting Author: Ravi

Sarode

- PB0560. Use of heparin-calibrated assays to estimate anti-factor Xa activity

of factor Xa inhibitors (FXaI): a literature correlation analysis. Presenting

Author: Ravi Sarode

- PB0716. Prospective, Phase III Study of the Efficacy, Safety, and

Pharmacokinetics of a Human Antithrombin III Concentrate in Congenital

Antithrombin Deficiency During Surgery or Childbirth. Presenting Author:

Cristina Solomon

- PB0541. Freeze-dried plasma development and assessment of biochemical

quality. Presenting Author: Andrea Heger

- VPB0492. LEX-211 (FARES-II): a phase 3, prospective, active-control

randomised study of four-factor prothrombin complex concentrate versus frozen

plasma in bleeding adult cardiac surgery patients. Presenting Author: Jeannie

Callum

Tuesday July 12, 18:30–19:30

- PB1149. Pooled analysis of long-term efficacy and safety of simoctocog alfa

in previously treated patients with haemophilia A. Presenting Author: Gita

Pezeshki,

- PB1134. Practical utilisation of Octapharma FVIII concentrates in previously

untreated and minimally treated haemophilia A patients entering routine

clinical treatment – The Protect-NOW Study. Presenting Author: Susan Halimeh

- PB1126. Safety and efficacy of simoctocog alfa in patients with haemophilia A

in routine clinical practice (GENA-99). Presenting Author: Claire Berger

- VPB0996. FiiRST-2; a prospective, randomized study of clotting factor

concentrates versus standard massive haemorrhage protocol in severely bleeding

trauma patients. Presenting Author: Jeannie Callum

"We are excited to share our new data and updates at ISTH," said Olaf Walter,

Board Member at Octapharma. "Despite advances in the field, managing emergency

bleeding and bleeding disorders still comes with considerable challenges. We

are constantly striving to address these challenges head-on and to lessen these

patients' burdens to improve their day-to-day lives."

New data will also be shared during two Supported Symposia as part of

Octapharma's 'Under the Spotlight' series.

- A Key Factor: Aiming for All-Round Bleed Protection in Haemophilia A  

Saturday July 9, 11:30–12:45 BST

Chair: Dr Georgina Hall, John Radcliffe Hospital, Oxford, UK

The symposium will focus on new clinical and scientific insights into the use

of Nuwiq(R) to improve the lives of people with haemophilia A. The topics

include the use of matching-adjusted indirect comparisons to assess the

relative clinical impact of personalised prophylaxis with different FVIII

products, and the use of combination therapy to manage bleeding in people with

haemophilia A undergoing major surgery. Also presented will be new in vitro

data on the binding of FVIII to platelets, and the use of novel RNA sequencing

methods to help predict the risk for inhibitor development in children treated

for the first time with FVIII.

- Focus on Females: Patient Experience and Novel Treatment Strategies in

Bleeding Disorders Tuesday July 12, 13:15–14:30 BST

Chair: Dr Veronica Flood, Medical College of Wisconsin, Milwaukee, USA

Women with bleeding disorders face unique challenges; many are left untreated

or are diagnosed late, which can increase their bleeding risk and impact

quality of life. During the symposium, the distinguished panel will discuss the

challenges faced by women and girls with von Willebrand disease and haemophilia

A. The speakers will illustrate the need for increased awareness and

women-specific clinical data, as well as treatment guidelines to support

clinicians in making well-informed treatment decisions for female patients with

bleeding disorders. New and ongoing studies with wilate(R) and Nuwiq(R) will be

presented that aim to improve the management of women with von Willebrand

disease or haemophilia A.

"We look forward to continuing our efforts in raising awareness around and

improving the care for women with bleeding disorders, with the ultimate goal of

ensuring that these patients have the ability to receive safe and effective

management for their symptoms," commented Larisa Belyanskaya, Head of IBU

Haematology at Octapharma.

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 around 10,000 people worldwide to support the treatment of

patients in 118 countries with products across three therapeutic areas:

Immunotherapy, Haematology, and Critical Care.

Octapharma has seven R&D sites and five state-of-the-art manufacturing

facilities in Austria, France, Germany and Sweden, and operates more than 180

plasma donation centres across Europe and the US.

About Nuwiq(R)

Nuwiq(R) (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 protein[1]. 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 factor[1]. Nuwiq(R) treatment has been assessed in

seven completed clinical trials which included 280 patients with severe

haemophilia A, of which were 190 previously treated patients (PTPs; 190

individuals) and 90 were previously untreated patients (PUPs)[1]. Nuwiq(R) is

available in 250 IU, 500 IU, 1000 IU, 2000 IU, 2500 IU, 3000 IU and 4000 IU

presentations[1]. Nuwiq® is approved for use in the treatment and prophylaxis

of bleeding in patients with haemophilia A (congenital FVIII deficiency) across

all age groups[1].

About wilate(R)

wilate(R) is a high-purity human von Willebrand factor/factor VIII (VWF/FVIII)

concentrate, that undergoes two virus inactivation steps during its

production.[2] No albumin is added as a stabiliser[2]. The purification

processes result in a 1:1 ratio of VWF to FVIII that is similar to normal

plasma[2]. wilate(R) contains a VWF triplet structure and content of large high

molecular weight multimers similar to normal human plasma[2]. wilate(R) is

exclusively derived from large pools of human plasma collected in approved

plasma donation centres[3]. wilate(R) is available in 500 IU and 1000 IU

presentations. wilate(R) 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)[3].

1. Nuwiq(R) Summary of Product Characteristics.

2. Stadler M et al. Biologicals 2006; 34:281-8.

3. wilate(R)Summary of Product Characteristics.

Octapharma press releases are specifically for health specialist/medical media

and are not for consumer press.

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Source: Octapharma