Business Wire

Final Data From the NuProtect Study Published on the Immunogenicity of Nuwiq ® in Previously Untreated Patients With Severe Haemophilia A

Share

Octapharma announced today that the final results from the NuProtect study on the immunogenicity of Nuwiq® in previously untreated patients (PUPs) with severe haemophilia A have been published in the leading medical journal Thrombosis and Haemostasis (Liesner RJ et al. “Simoctocog Alfa (Nuwiq®) in Previously Untreated Patients with Severe Haemophilia A: Final Results of the NuProtect Study” https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0040-1722623).

The NuProtect study (NCT01712438; EudraCT 2012-002554-23) was a prospective, multinational, open-label, non-controlled phase III study initiated in March 2013 to assess the immunogenicity, efficacy and safety of Nuwiq®. The study recruited patients of any age and ethnicity at 38 sites in 17 countries and followed patients for 100 exposure days or up to 5 years. With enrolment of 110 patients, the NuProtect study was the largest clinical study to investigate a single product in true PUPs.

Of 105 evaluable PUPs with severe haemophilia A who received Nuwiq® for the prevention and treatment of bleeding:

  • 16.2% (17/105) of patients developed high-titre inhibitors
  • 10.5% (11/105) of patients developed low-titre inhibitors, five of which were transient
  • 26.7% (28/105) of patients developed any inhibitor

The NuProtect study showed that there was a low risk of inhibitor development in PUPs starting treatment with Nuwiq®,” commented Dr Ri Liesner, coordinating investigator of the NuProtect study and clinician at Great Ormond Street Hospital for Children in London, UK. “These data indicate Nuwiq® may be an attractive option for people newly diagnosed with severe haemophilia A, who are young children and represent a vulnerable patient subset.”

The development of inhibitors to replacement factor VIII (FVIII) is a concern for doctors, as well as for patients and their families, particularly when first starting treatment. Inhibitors render FVIII therapy ineffective and limit treatment options.

These data complement the wealth of clinical experience in patients with haemophilia A receiving Nuwiq® for the treatment and prevention of bleeding.

“Nuwiq® was developed in a human cell line with the aim of minimising inhibitor risk in PUPs,” said Larisa Belyanskaya, Head of Octapharma’s IBU Haematology. “We are pleased to be able to share these positive data, which reflect this aim and which we hope will contribute to addressing this key treatment challenge.”

We know that haemophilia A patients face a lifetime of treatment decisions,” commented Olaf Walter, Board Member at Octapharma. “These data highlight the potential of Nuwiq® to reassure PUPs and their families as they start their treatment. This publication brings us closer to Octapharma’s goal of enabling all patients to lead healthy lives.”

Earlier this year the FDA approved the inclusion of the immunogenicity data from the NuProtect study in the Nuwiq® Prescribing Information. Further publications on other analyses from the NuProtect study are planned.

Professor Anthony Chan, a co-author of the publication and Professor of Paediatrics at McMaster University, Canada, said: “Congratulations and thanks to Octapharma for developing Nuwiq, sponsoring the trial and providing a very good therapy for patients with haemophilia A.

Octapharma would also like to extend thanks to all participating centres, as well as patients and their caregivers, for their contribution to the study.

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; 10:2040620719858471.
2. Nuwiq® Summary of Product Characteristics.

About Haemophilia A

Haemophilia A is an X-linked hereditary bleeding disorder caused by a deficiency of factor VIII (FVIII) which, if left untreated, may lead to haemorrhages in muscles and joints and consequently to arthropathy and severe morbidity. The disorder affects around one in every 10,000 males worldwide. Prophylaxis with replacement FVIII therapy reduces the number of bleeding episodes and the risk of permanent joint damage.

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 9,000 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, and operates more than 160 plasma donation centres across Europe and the USA.

Contact information

Octapharma AG Contacts:

Octapharma AG International Business Unit - Haematology
Olaf Walter
Olaf.Walter@octapharma.com

Larisa Belyanskaya
Larisa.Belyanskaya@octapharma.com
Tel: +41 55 4512121

Ivana Spotakova
Communications Manager
ivana.spotakova@octapharma.com
Tel.: +41793474607

About 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.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

CGTN: China Outlines Plan to Address Economic Challenges in Next 5 Years5.3.2021 14:02:00 CETPress release

China has set a gross domestic product (GDP) growth target of over six percent for 2021 and outlined a plan to promote innovation, green development, and common prosperity in the next five years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210305005288/en/ Addressing the country's annual legislative session, Premier Li Keqiang on Friday explained how China is going to tackle the numerous challenges it faces in a new development stage. "China remains in an important period of strategic opportunity for development. Yet, there are changes in both the opportunities and challenges we face," Li said when delivering a government work report at the opening meeting of the fourth session of the 13th National People's Congress (NPC), China's top legislature. 'Extraordinary year' Describing 2020 as "an extraordinary year in the history of the People's Republic of China," the premier underscored China's "major strategic success" in fi

Everbridge Awarded Revolutionary New Public Warning Patent for Technology that Automates the Selection of the Optimal Communications Channels to Reach the Broadest, Hyper-Targeted Populations – as Fast as Possible – During a Crisis5.3.2021 13:30:00 CETPress release

Everbridge, Inc. (NASDAQ: EVBG), the global leader in critical event management (CEM), today announced the company received a revolutionary new patent related to its world-class Public Warning system. The patent pertains to technology focused on hybrid population alerting systems and intelligent sending of messages in public mobile networks. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210305005260/en/ Everbridge Awarded Revolutionary New Public Warning Patent (Photo: Business Wire) Everbridge represents the first population alerting provider to serve the entire populations of 11 countries in Europe, Asia, Oceania, the Middle East, Africa, and the Americas, supporting five European Union (EU) countries in conjunction with the EU mandate requiring member countries to have a population-wide alerting system in place by June 2022. In compliance with GDPR, Everbridge Public Warning neither collects nor stores personally identif

COVID-19’s Economic Pinch Drives More Nordic Enterprises Toward Business Process Automation for Competitive Edge5.3.2021 10:00:00 CETPress release

Large enterprises in the Nordics have been implementing business process automation over the last three years, and more organizations now see the urgency of adopting these technologies to stay competitive as COVID-19 strains the regional economy, according to a new report published today by Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm. The 2020 ISG Provider Lens™Intelligent Automation – Solutions and Services report for the Nordics finds banking, financial services and insurance companies have led the region in adopting business process automation, seeking higher productivity, cost savings and improved customer experience. Manufacturing, retail and other sectors are also embracing the technologies, which include conversational AI, natural-language processing and AI for IT operations (AIOps). “Early adopters of automation in the Nordics are stepping up digital transformation to gain an advantage when they need it most,” said Jan

International Fashion Designer Anna Chybisova Draws Major Investments Worth $9 Million for her Brand Maison d’Angelann5.3.2021 09:52:00 CETPress release

Following a series of successful market takeovers, Anna Chybisova takes another step towards success by securing another major investment for Maison D’angelann. The Gate Business Service, a private family office based out of the United Arab Emirates, has been announced as the latest investor to back Anna’s brand globally. After having invested $7 million late last year, Gate Business Service secures an additional $2 million worth of investment against a majority stake in Maison d’Angelann fashion brand. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210305005133/en/ Anna Chybisova, Fashion Designer & Owner, Maison d’Angelann (Photo: AETOSWire) Anna Chybisova’s designs and business acumen are the foremost reasons behind such heavy investments by the new partner. Reporting sales over $2 million within UAE alone and a sold-out Spring/Summer 2021 collection has strengthened the investor confidence. This growing success and custo

Xlife Sciences AG (XLS): Joint Venture With anfass Life Technologies5.3.2021 08:48:00 CETPress release

Xlife Sciences AG and Solothurn-based anfass Life Technologies AG have entered a joint venture. Hence, the jointly founded Quadira Biosciences AG has access to the 3D CoSeedis(TM) technology platform of abc biopply ag. This unique 3D cell technology enables the replication of human tissue for reliable testing and characterization of antibodies without animal testing. Xlife's technology platform for the development of antibodies will be used even more efficiently. As of today, Xlife Sciences AG has already identified 30 compounds with blockbuster potential with its antibody screening platform. These therapeutic antibodies have already shown to be safe and effective in humans. Xlife can modify these antibodies with utmost accuracy and increase the quality of the active ingredient. These are mainly advanced, highly potent antibodies with higher cytotoxic activity and improved side effect profile for cancer therapy. The target market potential of the pre-selected antibodies is in the range

Moody’s Analytics Wins IFRS 9 Solution Provider of the Year5.3.2021 08:30:00 CETPress release

Moody’s Analytics has won IFRS 9 Solution Provider of the Year in the 2021 Insurance Asset Risk Awards. It is the latest recognition for our capabilities in this space following wins for IFRS 9 – Enterprise Solution of the Year and IFRS 9 – ECL Modelling Solution of the Year at last year’s Risk Technology Awards. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210304006204/en/ Central to our offering for insurers is the ImpairmentStudio™ for IFRS 9 solution, a cloud-based platform that brings together our award-winning economic scenarios, data, models, and enterprise software. Financial institutions use it to automate the credit loss impairment calculations mandated by the new IFRS 9 accounting standard. For insurers, these new financial reporting requirements call for much more granular data than was previously needed. The Moody’s Analytics offering helps them access and use all of the required data while managing and monito

Mitsubishi Heavy Industries Engineering to Test Carbon Capture Technology at Technology Centre Mongstad in Norway5.3.2021 07:43:00 CETPress release

Mitsubishi Heavy Industries Engineering (MHIENG), part of Mitsubishi Heavy Industries (MHI) Group, has entered into an agreement with Technology Centre Mongstad (TCM) to test its proprietary solvent for capturing CO2 at the amine plant located in Mongstad, Norway. The test campaign will start in May. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210304006210/en/ Technology Centre Mongstad located at the west coast of Norway (Photo: Business Wire) The proprietary solvent to be tested is the KS-21TM, an amine-based adsorbent used in the “Advanced KM CDR ProcessTM” newly developed by MHIENG in collaboration with Kansai Electric Power Co., Inc. (KEPCO). Its long-term usage will be demonstrated in Norway, one of the world’s most advanced countries with respect to environmental regulations on CO2 capture, in a quest to achieve commercialization within 2021. Compared to the earlier KS-1TM solvent, which has been adopted at 13 comm