Business Wire

Publication of Clinical Data Demonstrating Low Immunogenicity and Excellent Efficacy of Nuwiq® in Previously Untreated Patients

Del

Octapharma is delighted to announce the publication of interim data from the NuProtect study (GENA-05, NCT01712438), the first clinical data on treatment with Nuwiq® in previously untreated patients (PUPs), on August 16th 2017 as an Early View article in the internationally renowned medical journal Haemophilia.

The NuProtect study was initiated in March 2013 to investigate the immunogenicity, efficacy and safety of Nuwiq® in PUPs with severe haemophilia A, who are at the greatest risk of developing inhibitors. The ongoing study has enrolled 110 PUPs of any age or ethnicity who will receive Nuwiq® for up to 100 exposure days (EDs), making it one of the largest studies with a single FVIII product. Patients who previously received any FVIII concentrates or blood products containing FVIII are excluded from the study.

The recently published article describes interim results for 66 PUPs treated for at least 20 EDs, the time by which most inhibitors arise. The cumulative incidence (95% confidence interval) was 20.8% (10.7–31.0) for all inhibitors and 12.8% (4.5–21.2) for high-titre inhibitors. The study reported excellent efficacy of Nuwiq® in the prevention of bleeds, with median annual bleeding rates of 0 for spontaneous bleeds and 2.40 for all bleeds. Nuwiq® was also efficacious for the treatment of bleeds (92.4% of bleeds were controlled with one or two infusions) and as surgical prophylaxis (rated as “excellent” or “good” for 89% of surgical procedures). These interim results confirm the excellent haemostatic efficacy reported with Nuwiq® in previously treated patients.

Larisa Belyanskaya, Head of IBU Haematology, said: “We are very excited by the results of the NuProtect study and pleased that these interim data are now available as a publication in the specialist peer-reviewed journal Haemophilia. This is the first study to report data from PUPs treated with a rFVIII produced in a human cell line, and the results further differentiate Nuwiq ® from other products on the market.”

Olaf Walter, Board Member at Octapharma, added that “These data demonstrate low immunogenicity of Nuwiq ® in PUPs, the patient group at the greatest risk of inhibitor development, and confirm the excellent efficacy observed in previously treated patients. This publication is a further important step towards Octapharma’s goal of enabling patients with coagulation disorders to live a normal life.”

Octapharma would like to thank everyone involved in the study, in particular the patients and their families, without whom this research would not be possible.

About the NuProtect (GENA-05) study

The NuProtect clinical study (NCT01712438) is a phase 3, open-label, interventional clinical study being conducted across 38 centres, to evaluate at least 100 previously untreated patients (PUPs) with severe haemophilia A of all ages and ethnicities enrolled for study up to 100 exposure days (EDs) or 5 years maximum. Patients treated previously with any FVIII concentrates/blood products containing FVIII are excluded. The primary objective is to assess the immunogenicity of Nuwiq® by determining inhibitor activity using the Nijmegen-modified Bethesda assay at a central laboratory. Final data from the NuProtect study are expected to become available in 2019. More information on this trial is available at www.clinicaltrials.gov. An extension study (GENA-15, NCT01992549) will further evaluate the long-term immunogenicity, efficacy and safety of Nuwiq® in PUPs.

About Nuwiq ®

Nuwiq® is a 4th generation rFVIII protein1, produced in a human cell line without chemical modification or fusion with any other protein2. Nuwiq® is cultured without additives of human or animal origin2, is devoid of antigenic non-human protein epitopes3 and has a mean half-life of 17.1 hours4,5 and a high affinity for the von Willebrand coagulation factor6. Nuwiq® treatment has been assessed in seven completed clinical trials which included 201 PTPs7,8 (190 individuals) with severe haemophilia A, including 59 children9. 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.

References:
1. FDA Nuwiq® memorandum (STN 125555\0), 9 October 2014.
2. Casademunt E, et al. Eur J Haematol 2012; 89: 165-76.
3. Kannicht C, et al. Thromb Res. 2013;131:78-88.
4. Nuwiq® European Public Assessment Report, 22 May 2014.
5. NUWIQ® US Prescribing Information, September 2015.
6. Sandberg H, et al. Thromb Res 2012; 130: 808-17.
7. Valentino LA, et al. Haemophilia 2014; 20(Suppl. 1): 1-9
8. Lissitchkov T, et al. Haemophilia 2017; e-pub ahead of print; doi: 10.1111/hae.13251
9. Klukowska A, et al. Haemophilia 2016; 22, 232-39.

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 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

Contact information

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

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Huawei Brings the All-Connected World to Mobile World Congress25.2.2018 13:30Pressemelding

Building on its success in delivering beautifully-designed and powerful high-end mobile devices, Huawei Consumer Business Group (CBG) today unveiled the HUAWEI MateBook X Pro, the HUAWEI MediaPad M5 Series and the HUAWEI 5G customer-premises equipment (CPE), the world’s first commercial terminal device supporting the globally recognized 3GPP telecommunications standard for 5G. With stunning new design updates and outstanding performance advances, Huawei’s new devices showcase the power of technology to deliver innovative computing experiences ready for the mobile world. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180225005135/en/ MateBook X Pro (Photo: Business Wire) “At Huawei, we’re guided by a vision of an all-connected world, and to achieve that goal, we invest significantly in research and development to understand the ways in which people interact and connect with technology,” said Richard Yu, CEO of Huawei CBG. “We’

The 6th Annual World Patient Safety, Science & Technology Summit Kicked off with an Important Announcement about the Progress Being Made to Save Lives in Hospital Settings24.2.2018 10:00Pressemelding

The 6th Annual World Patient Safety, Science & Technology Summit kicked off with an important announcement about the progress being made to save lives in hospital settings. Nearly 4,600 hospitals in 44 countries have committed to adopting patient safety processes that are proven to eliminate preventable deaths in hospitals. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180224005027/en/ England’s Health and Social Care Secretary, Rt. Hon. Jeremy Hunt, launches groundbreaking new measures on Day One of the 6th Annual World Patient Safety, Science & Technology held in London (Photo: Business Wire) The Patient Safety Movement Foundation has taken on an inspiring and ambitious goal of reducing preventable patient deaths in hospitals to ZERO by 2020. The annual Summit in central London plays a major role in taking on that challenge with the participation of 300 global leaders, medical experts, medical technology CEOs, and patient

WuQi Technologies is Latest Licensee of CCww’s NB-IoT UE Protocol-Stack Software24.2.2018 09:06Pressemelding

Communications Consultants Worldwide Ltd. (CCww), global innovator of 3GPP® technologies, has licensed its NB-IoT protocol-stack software to WuQi Technologies Inc., a leading global developer of highly integrated mixed-signal SoC solutions, and the latest licensee of CCww’s NB-IoT Release 13 UE protocol-stack software. Communications Consultants Worldwide (CCww) is working with WuQi Technologies for the integration of its NB-IoT protocol-stack software onto WuQi Technologies’ highly innovative SoC. This relationship, catalyzed by T2M, is enabling the production of a highly integrated, very low power, NB-IoT SoC chipset targeting IoT Smart City, Smart Home, and wearable applications. CCww’s CEO, Richard Carter, said, “NB-IoT is CCww’s latest cellular Protocol-stack SW. We are excited to be working with WuQi to enable a sector-leading NB-IoT SoC, pushing back boundaries of performance and battery life for the next generation of IoT. See our demonstration at the Mobile World Congress (Hal

IDEMIA and Octo Telematics Reinvent Car Sharing Experience by Adding Facial Recognition to EasyOpen Solution23.2.2018 15:57Pressemelding

IDEMIA, the global leader in Augmented Identity for an increasingly digital world, announces today that it has implemented facial recognition technology on EasyOpen, a solution previously developed with its partner Omoove, a wholly-owned Octo Telematics company, Europe’s leading Shared Mobility technology provider. The digital enrolment process combined with facial recognition technology will securely enroll and authenticate the driver before EasyOpen automatically opens the car. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180223005506/en/ (Photo: Idemia) You will never rent a car the same way thanks to EasyOpen solution that combines IDEMIA’s expertise in secure service enablement and Omoove’s experience in Shared Mobility platforms and on-board technology. The first version of the solution was launched last year and allows drivers, who have already registered on the application, to use their smartphones as a key to open

SM-Optics Unveils First FLEXSET Chip, Paving the Way to Optical Micro Nodes23.2.2018 14:00Pressemelding

SM-Optics launches FLEXSET, a single chip embedding multiple processing functionalities raising the bar for performances, density and architectural flexibility. The FLEXSET is the heart of the Lightmode product family. FLEXSET OTN switching matrix scales from 300Gbps to 1Tbps and can be addressed by ports spanning from traditional low-speed services like 2Mbps over micro-OTN, to layer2 and layer3 over ODUFlex, 100G over ODU4 and 200G over FlexO. Thanks to its embedded capabilities including multi-technology OAM, packet processing, synchronization and fast protection functions, FLEXSET operates by design at the lowest latency performances and features an Intel Stratix 10 FPGA. Following the launch of micro-OTN, a revolutionary approach to efficiently extend OTN protocol to low speed services, the launch of FLEXSET advances the vision of a highly interconnected metro network and of micro nodes. Revolving around functional block elements, micro nodes collapse in few rack units OTN and pho

Bitcoin Miner HashGains’ Crowdsale to Build Green Cloud Mining Data Centers Receives Excellent Response23.2.2018 13:56Pressemelding

HashGains.com, a leading cryptocurrency mining platform, has launched its crowdsale program to build mega cryptocurrency cloud mining data centers in India and Canada which uses renewable energy like wind and solar as source of energy. “With the growing worries around bitcoin mining causing environmental damage, difficulty levels of mining increasing and returns heading southwards, there was no better opportunity but to build green energy data centers which run on free sources of energy like wind and solar, ensuring handsome mining rewards while taking care of environment,” said Mr Anuj Bairathi, CEO & Founder, HashGains, who is crypto enthusiast himself. HashGains is a growing cloud mining platform with more than 10,000 active customers enjoying mining returns and is expected to reach the mark of 1 million customers by 2020. To handle such a massive growth and ever growing demand of customers, it becomes even more important that mega mining centers are planned which can serve needs of