Octapharma present new data on the benefits of Nuwiq® in patients with haemophilia A at the World Federation of Hemophilia 2018 World Congress
Octapharma announced today that new data on the benefits of Nuwiq® in patients with haemophilia A were presented during a symposium at the recent World Federation of Hemophilia (WFH) 2018 World Congress in Glasgow, UK. Nuwiq® is a 4th generation human cell line-derived recombinant FVIII (rFVIII) approved for the prevention and treatment of bleeding episodes in patients of all ages with haemophilia A. The symposium, entitled ‘Going further to meet clinical needs: New data with Nuwiq ® ▼ (simoctocog alfa; human-cl rFVIII) from clinical trials and real-world experience’, focused on the challenges within the current haemophilia treatment landscape and opportunities to improve patient care.
The symposium, chaired by Craig Kessler, addressed the reality that no two haemophilia A patients are the same. An optimal treatment approach should therefore reflect each individual patient’s profile. Striving towards this goal, two approaches to using pharmacokinetic (PK) data to personalise prophylaxis with Nuwiq® were presented in the symposium. John Pasi (The Royal London Hospital, London, UK) shared a summary of the NuPreviq study, which uses an individual’s PK profile to optimise the treatment plan1. This individualised dosing approach enabled over half (57%) of patients in the NuPreviq study to reduce dosing with Nuwiq® to twice weekly or less, whilst maintaining effective bleed protection (median annualised bleeding rate [interquartile range]: 0 [0, 1.9]) for all bleeds). During personalised prophylaxis with Nuwiq®, 83% of patients were spontaneous bleed free. A second approach, using WAPPS (Web Accessible Population Pharmacokinetics Program), was presented by Stacy Croteau (Boston Children’s Hospital, Boston, USA). This approach uses the PK analysis of a group of people to predict the optimal treatment for an individual, and provides a flexible approach to dosing that requires fewer samples. A Nuwiq®-specific WAPPS model is available and is based on PK data from 114 patients, including 26 children, treated with Nuwiq®. These approaches represent promising steps towards achieving personalised haemophilia care.
For previously untreated patients (PUPs), the risk of inhibitor development remains the greatest concern with haemophilia treatment. Ellis Neufeld (St. Jude Children’s Research Hospital, Memphis, USA) presented an overview of interim data from the NuProtect study, which is investigating Nuwiq® in PUPs2. The interim data indicate a cumulative incidence of high-titre inhibitors of only 12.8% in patients treated with Nuwiq®.The presentation also included data from a recent sub-analysis of inhibitor development based on patients’ F8 gene mutation status3. This analysis demonstrated a cumulative inhibitor incidence of 26.7% in patients with high-risk mutations, whilst no patients with low-risk mutations developed inhibitors. Dan Hart (The Royal London Hospital, London, UK) presented a novel genomic approach to further analyse data from the NuProtect study, with the aim of predicting inhibitor risk using transcriptional profiles.
Ri Liesner (Great Ormond Hospital for Children, London, UK) presented real-world data on the use of Nuwiq® for immune tolerance induction (ITI), which remains the only proven strategy to eradicate inhibitors. Three of the five patients in the cohort have achieved eradication of inhibitors, while the other two remain on ITI and show continued decline in inhibitor levels.
Larisa Belyanskaya, Head of Octapharma’s IBU Haematology stated “we at Octapharma are delighted with the excellent data presented at WFH 2018, which build on the growing wealth of positive experience with Nuwiq ® . The broad range of data demonstrate the expanding value of Nuwiq ® in clinical practice and highlight Octapharma’s commitment to ‘going further’ to address the developing demands of haemophilia A patients”. Olaf Walter, Board Member at Octapharma, added “The data presented at the symposium build on a broad portfolio of clinical experience with Nuwiq ® . The WFH congress is a key platform for sharing information in the haemophilia field and Octapharma is proud to present new data on Nuwiq to the international haemophilia community at this meeting”.
About Nuwiq ®
Nuwiq® is a 4th generation rFVIII protein4, produced in a human cell line without chemical modification or fusion with any other protein5. Nuwiq® is cultured without additives of human or animal origin5, is devoid of antigenic non-human protein epitopes6 and a high affinity for the von Willebrand coagulation factor7. Nuwiq® treatment has been assessed in seven completed clinical trials which included 201 PTPs8,9 (190 individuals) with severe haemophilia A, including 59 children10. 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 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%.
The vision of Octapharma is “Our passion drives us to provide new health solutions advancing human life”. 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. Our company values are Ownership, Integrity, Leadership, Sustainability and Entrepreneurship.
In 2017, the Group achieved €1.72 billion in revenue, an operating income of €349 million and invested €287 million to ensure future prosperity. Octapharma employs around 7,700 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 has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden.
For more information visit www.octapharma.com
1. Lissitchkov T, et al. Haemophilia 2017;23:697-704.
2. Liesner R, et al. Haemophilia 2018;24:211-220.
3. Liesner R, et al. Blood eLetter 2018; available at http://www.bloodjournal.org/content/early/2017/08/02/blood-2017-06-791756
4. Lieuw K. J Blood Med 2017; 8: 67–73.
5. Casademunt E, et al. Eur J Haematol 2012; 89: 165-76.
6. Kannicht C, et al. Thromb Res. 2013; 131: 78-88.
7. Sandberg H, et al. Thromb Res 2012; 130: 808-17.
8. Valentino LA, et al. Haemophilia 2014; 20(Suppl. 1): 1-9.
9. Lissitchkov T, et al. Haemophilia 2017; 23: 697–704.
10. Klukowska A, et al. Haemophilia 2016; 22, 232-39.
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 ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
SCG Chemicals Company chooses gPROMS modelling for digital design and operations22.3.2019 18:55:00 EET | Tiedote
Process Systems Enterprise (PSE), the Advanced Process Modelling company, today announced that it has signed a long-term agreement with SCG, one of the largest integrated petrochemical companies in South East Asia, to standardise on PSE’s gPROMS® modelling technology for digital design and operations. SCG applies advanced process models within digital design initiatives to explore the process decision space rapidly and effectively, in order to reduce uncertainty and make better, faster and safer design and operating decisions. This help them to accelerate innovation and optimise the design and operation of their process plants. Dr Suracha Udomsak, SCG’s Emerging Business Director and R&D Director, says, “at SCG Chemicals, advanced process modelling (APM) is a key element in our Digital Manufacturing platform. APM accelerates innovation by making the development workflow ‘faster, cheaper & safer’, which are key considerations for us. It is a core technology building block that enables u
Logicor Announces Results for Year Ended 31 December 201822.3.2019 17:29:00 EET | Tiedote
Logicor announces strong financial performance for the year ended 31 December Net Operating Income (NOI): €639 million, which represents year on year growth of 2.5%, reflecting our strategic focus on increasing occupancy and capturing market rental growth. Over 60% of NOI is generated in the key markets of the UK (26%), Northern Europe1 (21%) and France (15%). Gross Asset Value: €12.5 billion, a 3.3% increase in valuation, which reflects the strong performance of our portfolio, in particular in Northern Europe. EPRA Occupancy: 94.4%, with physical occupancy up 70 bps over the year, underpinned by strong growth in each of our three largest regions of the UK (+120 bps), Northern Europe (+110 bps) and France (+220 bps). LTV: 51%, down from 52% at year end 2017 following increases in property values. At year end, our debt to EBITDA ratio was 11.3x. Capital Structure In 2018 Logicor (rated BBB (Stable) by S&P) established a Euro Medium Term Note (‘EMTN’) programme and raised €1.8 billion of
Delticom AG/Mytyres.co.uk: Buying Great Value Tyres Online Doesn’t Mean Missing out on Professional Fitting22.3.2019 17:15:00 EET | Tiedote
Spring is just around the corner, and it’s time for drivers to start thinking about changing to summer tyres. However, a tyre check may show that your current summer tyres are getting old, worn out, or have visible damage, such as cracks or bumps. If this is the case, then it's time for a new set of tyres. The legal minimum tread depth is 1.6 mm, however experts recommend significantly more – summer tyres should be replaced even if the tread depth is 3 mm. Regardless of mileage, you should change your tyres at least every eight to ten years. This is because the rubber starts to harden, the tyres lose grip on the road, and driving performance is affected. Of course, a set of four new tyres is a significant investment – authorised workshops can often charge between 250 and 350 pounds. If you want to save money, consider the alternatives: the result is an increasing number of customers turning to online shops such as Mytyres.co.uk to buy new tyres. The market share of tyres sold online ha
Trueman Man Clinic Achieves 10000 Surgery Milestone with Its SWITCH Operation22.3.2019 16:00:00 EET | Tiedote
Trueman Man Clinic Network announced that the 10,000th surgery utilizing its SWITCH Premature Ejaculation Surgery (Nerve Conservation), has been successfully completed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190322005013/en/ Trueman Man Clinic Network has been successfully completed the 10,000th surgery utilizing its SWITCH Premature Ejaculation Surgery (Nerve Conservation). The SWITCH Premature Ejaculation Surgery (SWITCH operation) developed in 2010 by Dr. Yang, the chief director of the Trueman Man Clinic Network, can reduce the side effects of penile neurectomy and maintain the stable reduction of the glans sensation. The Trueman Man Clinic Network is the leading hospitals for male enhancement surgeries in Korea consists of 11 clinics, with 16 doctors working. As of 2019, more than 43,000 man clinic surgeries have been performed. (Photo: Business Wire) The Trueman Man Clinic Network is the leading hospitals for m
Janssen Seeks Expanded Use of DARZALEX®▼ (daratumumab) Combination Therapy for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible22.3.2019 14:22:00 EET | Tiedote
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) for DARZALEX®▼ (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of patients newly diagnosed with multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). “Today’s submission brings us one step closer to our goal of improving treatment outcomes for people newly diagnosed with multiple myeloma,” said José Antonio Burón Vidal, VP Medical Affairs, Europe, Middle East and Africa (EMEA), Janssen-Cilag Limited. “We are incredibly grateful to the patients and investigators who participated in the MAIA clinical trial programme and look forward to working closely with the regulatory authorities to secure approval of this new combination.” The submission is supported by data from the Phase 3 MAIA (MMY3008) study, which were presented at the 60th Annual Meeting of the American
Bartek Ingredients Expands Leadership Team22.3.2019 01:35:00 EET | Tiedote
Bartek Ingredients Inc. recently completed a 4,000 ton/year capacity expansion for its malic and food-grade fumaric acid production facility, and today it announces the expansion of its leadership team, with the hiring of Jeff Billig as Vice President of Marketing & Business Development and Heinrich G. Schaefer as International Sales Director. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190321005785/en/ The global leader in malic and fumaric acid ingredients expands its leadership team. (Photo: Business Wire) Bartek’s investment in both its team and facilities reinforces its position as the leader in malic and fumaric acid globally and aligns with its mission to facilitate growth and increase global reach to better serve existing customers and markets while opening up new ones. Bartek’s addition of Billig and Schaefer lays the foundation for additional resource investment in the near future while rapidly increasing its sa
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