OCTAPHARMA

Octapharma today announced that it will be actively involved in a wide range of activities at this year’s International Society on Thrombosis and Haemostasis (ISTH) Congress. The Congress will be held in Berlin, Germany from 8–13 July. Octapharma is delighted to be a Platinum Sponsor of the Congress, reflecting an ongoing commitment to advancing the treatment of patients with haemophilia and von Willebrand disease (VWD).

Octapharma will play a prominent role at the ISTH Congress with activities including two sponsored scientific symposia and seven poster presentations during the scientific sessions. Abstracts of the posters will be published in the Research and Practice in Thrombosis and Haemostasis journal after the Congress.

The addition of Nuwiq^® , a human cell-line derived recombinant FVIII (rFVIII) for the treatment of haemophilia A, has extended Octapharma’s established haematology portfolio of coagulation factors – wilate^® (von Willebrand Factor (VWF) indicated for VWD and haemophilia A), octanate^® (VWD and haemophilia A) and octanine^® F (haemophilia B).

Two leading-edge symposia on new developments in bleeding management in Haemophilia A and VWD

The latest developments with Nuwiq ^® , a naturally long-acting rFVIII made in human cells to protect against bleeds while addressing the risk of inhibitors in patients with haemophilia A, will be discussed in a scientific symposium, “Life without limitation: Growing experience with Nuwiq ^® in patients with haemophilia A”. The symposium will be held on Sunday 9 July 2017 (16:15–17:45, Room A8). The symposium will focus on interim data from a clinical study (NuProtect) of Nuwiq^® in previously untreated patients as well as clinical trial (NuPreviq) data and real-life clinical experience with the NuPreviq approach of pharmacokinetic (PK)-guided personalised prophylaxis and its potential to reduce the number of infusions and bleeding rates in patients with haemophilia A.

The latest developments with wilate ^® , a high purity, double virus-inactivated VWF/FVIII concentrate containing both factors in a physiological 1:1 ratio, in VWD and haemophilia A, will be discussed in a scientific symposium, “wilate ^® for a lifetime of care: Bleeding management across high-risk patient populations” . The symposium will be held on Monday 10 July 2017 (13:15–14:30, Room Paris). The symposium will focus on the treatment of high-risk patients throughout life, including patients with FVIII or VWF inhibitors, women undergoing pregnancy and delivery with VWD, and ageing VWD patients.

Seven posters presenting new data and ongoing experience across products:

Four posters on Nuwiq ^® will be displayed during the Congress:

Monday 10 July, Exhibition Hall 2.2, authors present 12.00–13.15

• Efficacy and safety of Nuwiq ^® (Human-cl rhFVIII) in patients with severe haemophilia A undergoing surgical procedures. N. Zozulya et al., Poster PB227.
• Inhibitor development and efficacy in previously untreated patients with severe haemophilia A treated with Nuwiq ^® (Human-cl rhFVIII), a 4th generation recombinant FVIII of human origin. R. Liesner et al., Poster PB211.
• Long-term treatment with Nuwiq ^® (Human-cl rhFVIII) in previously treated children with severe haemophilia A. A. Klukowska et al., Poster PB207.
• Pharmacokinetic guided personalised prophylaxis with Nuwiq ^® (Human-cl rhFVIII) in adult patients with severe haemophilia A. C. Kessler et al., Poster PB1794.

Two posters on wilate ^® will be displayed at the Congress:

Monday 10 July, Exhibition Hall 2.2, authors present 12.00–13.15

• International clinical study investigating the incidence of inhibitors in previously untreated patients with severe haemophilia A treated with a high purity FVIII/VWF concentrate in a 1:1 ratio. T. Andreeva, et al., Poster PB238.
• Surgeries in adults and children with von Willebrand’s disease – results from the ongoing study Wilate-STATE. S. Halimeh, et al., Poster PB383.

A poster describing the final results of a clinical trial in PUPs with haemophilia A treated with octanate ^® , a human plasma-derived, high-purity, freeze-dried, double virus-inactivated FVIII concentrate, will be displayed at the Congress:

Wednesday 12 July, Exhibition Hall 2.2, authors present 12.00–13.15

• Final results from the PUP-GCP trial: A low inhibitor rate in previously untreated patients with severe haemophilia A treated with octanate ^® . A. Klukowska, et al., Poster PB1787.

Larisa Belyanskaya, Head of IBU Haematology at Octapharma, said: “We are very excited by the results across our haematology portfolio and look forward to sharing our latest data at the ISTH 2017 Congress”.

Olaf Walter, Board Member at Octapharma, commented that “Octapharma’s strong presence at the ISTH 2017 Congress reflects our ongoing commitment to improve the lives of patients with coagulation disorders.”

About Haemophilia A

Haemophilia A is an X-linked hereditary disorder caused by FVIII deficiency which, if left untreated, leads to haemorrhages in muscles and joints and consequently to arthropathy and severe morbidity. FVIII replacement prophylactic treatment reduces the number of bleeding episodes and the risk of permanent joint damage. This disorder affects one in every 5,000 to 10,000 men worldwide. Globally, 75% of haemophilia cases are left undiagnosed or untreated. The development of neutralising FVIII antibodies (FVIII inhibitors) against infused FVIII represents the most serious treatment complication. The cumulative risk of FVIII inhibitor development is reported to be currently up to 39%.

About von Willebrand disease

VWD is the most common of the inherited bleeding disorders, with approximately 1% of the population having VWF levels below normal. VWD is classified as type 1 (generally mild), type 2 (variable) or type 3 (severe). The symptoms of VWD are usually those of platelet dysfunction and include nose bleeds, skin bruises and haematomas, prolonged bleeds from trivial wounds, oral cavity bleeding, and excessive menstrual bleeding. Gastrointestinal bleeds are relatively rare, but may be very serious when they occur. Severe deficiency of VWF, or a specific defect in the interaction of VWF with FVIII, causes a secondary moderate deficiency of FVIII. These patients may have symptoms that are more characteristic of haemophilia, such as bleeds into joints or soft tissues including muscle and brain.

About Nuwiq ^®

Nuwiq^® is a natural, long-acting, 4^th generation rFVIII protein, produced in a human cell line without chemical modification or fusion with any other protein. Nuwiq^® is cultured without additives of human or animal origin, is devoid of antigenic non-human protein epitopes and has a high affinity for the von Willebrand coagulation factor. Nuwiq^® treatment has been assessed in seven completed clinical trials which included 201 PTPs with severe HA, including 59 children. Nuwiq^® is approved for use in the treatment and prophylaxis of bleeding across all age groups of PTPs with haemophilia A in the EU, US, Canada, Australia, Latin America and Russia. Further worldwide submissions for Nuwiq^® are planned.

About wilate ^®

wilate^® is the first double virus inactivated VWF/FVIII, high purity concentrate, utilising the solvent/detergent (S/D) process and Permaheat - a special terminal dry heating (TDH) step. The selected purification processes isolate the VWF/FVIII complex under highly protein protecting conditions, resulting in a 1:1 ratio of VWF:RCo (ristocetin cofactor) to FVIII activity that is similar to normal plasma. No albumin is added as a stabiliser. wilate^® is exclusively derived from large pools of human plasma collected in approved plasma donation centres. wilate^® contains a VWF triplet structure and content of large high molecular weight multimers similar to normal human plasma. The product is registered in more than 60 countries worldwide, including most EU countries, the US, Canada, Australia, Brazil and Russia.

About octanate ^®

octanate^® is a human plasma-derived, high-purity, freeze-dried, double virus-inactivated FVIII concentrate for intravenous administration. Coagulation FVIII present in octanate^® is bound to its natural stabiliser, von Willebrand factor (VWF), in a VWF/FVIII ratio of approximately 0.4. Therefore, no additional stabilisers are required during manufacturing.

octanate^® is used in the prophylaxis and treatment of bleeding in patients with all types of haemophilia A. octanate^® is available in 250 IU, 500 IU and 1000 IU presentations. octanate^® was first launched in Germany in 1998 and has since been approved in 86 countries. Since its launch, a total of approximately 10 billion IU octanate^® have been distributed worldwide. octanate^® is indicated for immune tolerance induction (ITI) in over 40 countries.

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. As a family-owned company, Octapharma believes in investing to make a difference in people’s lives and has been doing so since 1983; because it’s in our blood.

In 2016, the Group achieved €1.6 billion in revenue, an operating income of €383 million and invested €249 million to ensure future prosperity. Octapharma employs more than 7,100 people worldwide to support the treatment of patients in 113 countries with products across three therapeutic areas:

· Haematology (coagulation disorders)

· Immunotherapy (immune disorders)

· Critical care

Octapharma owns six state-of-the-art production facilities in Austria, France, Germany, Mexico and Sweden.

For more information visit www.octapharma.com

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Contact:

Octapharma AG
International Business Unit- Haematology
Olaf Walter
Olaf.Walter@octapharma.com
or
Larisa Belyanskaya
Larisa.Belyanskaya@octapharma.com
Tel: +41 55 4512121

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