Business Wire

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

Jaa

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

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

"Complete Your Game!"The 13th Global Game Exhibition G-STAR 2017 Opens to Success21.11.2017 06:39Tiedote

The start of the G-STAR Game Show and Trade All Round 2017, an international game exhibition that examines the global gaming industry and its future possibilities, was announced at BEXCO, Busan, on November 16th. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171120006218/en/ Opening Ceremony of G-STAR 2017 (Photo: Business Wire) Celebrating its 13th anniversary this year, G-STAR 2017 is hosted by the Korea Game Industry Association (K-GAMES) and co-organized by the G-STAR Organizing Committee and the Busan IT Industry Promotion Agency. It runs for 4 days from the 16th to 19th (Sun). This year’s G-STAR 2017 has been a record success, bringing together 693 companies from 35 countries and exhibiting 2,857 booths - a 5.0% increase from the previous year. G-STAR 2017

The Indian Detective, Starring Russell Peters, Premieres Tuesday, December 19, 2017 on Netflix Worldwide20.11.2017 19:00Tiedote

Full release here. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171120005203/en/ (Photo: Business Wire) Following today’s announcement by Netflix, THE INDIAN DETECTIVE , a four-part comedy-drama series starring international comedy sensation Russell Peters, award-winning actor Anupam Kher (The Big Sick, Silver Linings Playbook), the iconic William Shatner (Star Trek), Christina Cole (Suits, Casino Royale), Hamza Haq (mother!, Bon Cop, Bad Cop 2), Akshay Kumar (Star Wars Ep VIII), Meren Reddy (Madiba, Homeland) and Mishqah Parthiephal (Keeping Up with the Kandasamys, Snake Park), will premiere on December 19, 2017 on Netflix worldwide, following an initial run on CTV Canada in November.

Andersen Global Expands Presence in Italy with New Location in Venice-Mestre, on the Venetian Mainland20.11.2017 17:30Tiedote

Andersen Global is proud to announce a new presence in Venice-Mestre, on the Venetian mainland in Italy through the expansion of Italian member firm, Andersen Tax & Legal. In addition, the Milan office will relocate at the end of November. The new office in Mestre and new location in Milan have been established to better serve the growing client base in Italy. Andersen Tax & Legal now has six locations in Italy: Milan, Brescia, Rome, Venice, Mestre, and Monza. Andrea De Vecchi, Office Managing Partner of Andersen Tax & Legal in Italy, and Regional Managing Partner in Europe shared, “Our new location in Venice-Mestre and expanded presence in Milan allow us to better serve our clients and continue to build our capabilities within the region. Through this expansion, we are able to reach new markets and also improve the quality of life for our employees.” Venice-Mestre is a sign

AGCO’s Innovation Rewarded with Prestigious Awards at Agritechnica 201720.11.2017 17:00Tiedote

AGCO, Your Agriculture Company, (NYSE:AGCO), a worldwide manufacturer and distributor of agricultural equipment and solutions, achieved remarkable success with 17 major awards at the prestigious Agritechnica 2017 event in Hannover, Germany. As a result of the votes cast by an independent expert committee, AGCO was once again one of the most successful manufacturers at Agritechnica 2017 by way of the number of innovation awards received. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171120005614/en/ The new Fendt Track Tractor 943 Vario MT won the treasured award "Machine of the Year 2018" in the Category XXL Tractors (Photo: Business Wire) “Winning these significant awards is a testament to our continued commitment to deliver high-tech solutions for farmers feeding the world,” said Martin Richenhagen

NexPlayer HTML5 Player Fully Compatible with Conviva across All Browsers and Devices20.11.2017 17:00Tiedote

NexStreaming, the provider of NexPlayer SDK, the market leader player SDK for OTT apps, announced today that the NexPlayer HTML5 player is fully compatible with Conviva Video AI Platform. This pre-integrated solution brings great value to video services: from now on, they will be able to enable the highest quality HLS & DASH live streaming across all browsers and devices with NexPlayer, and ensure an outstanding user experience with accurate analytics about the quality of the video experience thanks to Conviva. In this technology integration, NexPlayer HTML5 is fully optimized with Conviva’s QoE analytics. NexPlayer sends information regarding the use of the HTML5 based OTT service, including when the user pauses the video or the video is buffering as well as information about the frame-rate. Conviva measures and analyzes this information so that video service providers and publishers

Leading Broker ActivTrades Wins Le Fonti Forex Broker of the Year Award for the Second Time20.11.2017 16:30Tiedote

ActivTrades, one of the world’s leading online Forex Brokers, has won the Le Fonti Forex Broker of the Year Award for the second year running. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171120005576/en/ ActivTrades was awarded at the Le Fonti Awards (Photo: Business Wire) A UK-regulated firm with offices in Europe and the Middle East, ActivTrades was selected as the winner by the editorial staff of over 120 journalists at Le Fonti, the international and independent media company and research centre. Le Fonti credited the broker for “aiming to maximise its clients’ trading through a unique mix of superior value proposition, diverse product offering and stellar customer service”. Le Fonti’s judges added that ActivTrades offers “some of the tightest spreads in the industry” a

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme