Business Wire

Octapharma Present New Data on the Benefits Of Nuwiq® In Patients With Haemophilia A at the International Society on Thrombosis and Haemostasis (ISTH) 2019 Congress

Share

Octapharma announced today that new data on the benefits of Nuwiq® in patients with haemophilia A were presented during a scientific symposium at the 27th International Society on Thrombosis and Haemostasis (ISTH) Congress in Melbourne, Australia. The symposium, entitled ‘Conveniently Protecting What Matters: Nuwiq® (Simoctocog Alfa) in PUPs and Personalised Prophylaxis’, focussed on addressing some of the most important clinical needs of people with haemophilia A, and included final data from the NuProtect Study in previously untreated patients (PUPs), which were presented for the first time. The symposium was chaired by Ellis J. Neufeld (St. Jude Children’s Research Hospital, Memphis, USA).

Larisa Belyanskaya, Head of the Octapharma’s Haematology International Business Unit stated “We are very pleased to present the final data from the NuProtect study in PUPs, confirming the favourable rate of inhibitor development with Nuwiq® reported in the earlier interim analysis.”.

Olaf Walter, Board Member at Octapharma, said “The data presented at the symposium build on a broad clinical experience with Nuwiq®. The ISTH congress is a key platform for exchanging information in the international haemophilia field and we are proud to present these new and robust data in PUPs, which we believe will help to improve haemophilia A treatment”.

No two people with haemophilia A are the same, and therapy should therefore reflect the characteristics and needs of each individual. Robert Klamroth (Vivantes Klinikum, Berlin, Germany) presented data on the use of pharmacokinetic (PK) information to personalise prophylaxis with Nuwiq®. In the NuPreviq study, an individualised dosing approach enabled over half (57%) of patients to reduce dosing with Nuwiq® to twice-weekly or less, whilst providing effective bleed protection, with 83% of people free from spontaneous bleeds during the 6 months of personalised prophylaxis. There were no FVIII inhibitors or treatment-related serious or severe adverse events.

Inhibitor development remains a serious treatment complication of haemophilia A, particularly in PUPs, with up to 35% of PUPs developing inhibitors to FVIII. Ri Liesner (Great Ormond Street Hospital, London, UK) presented for the first time the final data from the NuProtect study, which investigated the development of inhibitors in 108 PUPs treated with Nuwiq®. The cumulative incidence of high-titre inhibitors was only 17.6%, and no patients with non-null F8 gene mutations developed inhibitors. Nuwiq® was well tolerated.

In people with haemophilia A who develop inhibitors, immune tolerance induction (ITI) is the only approach clinically proven to remove inhibitors and allow people to resume effective FVIII prophylaxis therapy. Georgina Hall (University of Oxford and John Radcliffe Hospital, Oxford, UK) shared real-world experience of using Nuwiq® for ITI, reporting inhibitor elimination in 8 of 10 (80%) patients treated so far. As new treatments become available for people with haemophilia A and inhibitors there is growing interest in the combination of ITI with other products. Carmen Escuriola Ettingshausen (Haemophilia Centre Rhein Main, Mörfelden-Frankfurt, Germany) introduced the investigator-initiated MOTIVATE study, which will investigate the efficacy and safety of “standard of care” ITI vs novel approaches combining FVIII with emicizumab, or emicizumab prophylaxis alone, in people with inhibitors.

About Nuwiq®

Nuwiq® is a 4th 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 previously treated patients (PTPs; 190 individuals) with severe haemophilia A, 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 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 up to 39%.

About Octapharma

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 2018, the Group achieved €1.8 billion in revenue, an operating income of €346 million and invested €240 million into R&D and in capital expenditures in order to ensure future prosperity. Octapharma employs 8,314 people worldwide to support the treatment of patients in 115 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

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

About Business Wire

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

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

IFF to Present at Barclays Global Consumer Staples Conference September 520.8.2019 23:15:00 EESTPress release

Regulatory News: IFF (NYSE: IFF) (Euronext Paris: IFF) (TASE: IFF), a leading innovator of taste, scent, and nutrition & ingredients today announced that the Company’s management will speak at the Barclays Global Consumer Staples Conference in Boston, Massachusetts, on Thursday, Sept 5, 2019 at 2:15 PM ET. Investors may access the live webcast and accompanying slide presentation on the Company's website at ir.iff.com. For those unable to listen to the live webcast, a recorded version will be made available for replay. Welcome to IFF At IFF (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF), we’re using Uncommon Sense to create what the world needs. As a collective of unconventional thinkers and creators, we put science and artistry to work to create unique and unexpected scents, tastes, experiences and ingredients for the products our world craves. Learn more at iff.com, Twitter , Facebook, Instagram, and LinkedIn. View source version on businesswire.com: https://www.businesswire.com/news/ho

Novalis LifeSciences Launches its First Life Science Investment Fund with $85 Million20.8.2019 19:29:00 EESTPress release

August 20th, 2019, Novalis LifeSciences, an investment and advisory firm for the Life Science industry, announced today that it has raised $85M in capital for its first fund - Novalis LifeSciences Investments I, L.P. Novalis LifeSciences is focused on highly innovative Life Science companies. On the occasion of closing the first fund, Marijn E. Dekkers, founder and chairman, said: “This first fund is a growth-oriented fund that will invest in 8-12 companies that are commercializing breakthrough technologies in various segments of the Life Science industry. This includes drug discovery, life science tools, genomics, synthetic biology, diagnostics, and agricultural biotechnology – all areas with huge unmet needs and exciting opportunities for investors”. About Novalis LifeSciences Novalis Lifesciences LLC, is a globally acting venture capital firm focused on breakthrough technologies in Life Science. Founded and managed by Dr. Marijn E. Dekkers, current chairman of Unilever and former ch

Bermuda Tech Week 2019 to Celebrate Innovation and Explore Opportunities for Growth20.8.2019 17:27:00 EESTPress release

Registration is under way and filling fast for Bermuda Tech Week 2019 which will take place at the Hamilton Princess & Beach Club from October 14-18, 2019. The programme of insightful and engaging events will explore future opportunities and challenges presented by emerging technologies such as artificial intelligence, blockchain, digital assets, insurtech and virtual reality. It will showcase Bermuda’s ongoing success in creating a welcoming, stable and well-regulated environment where technology and start-up companies can thrive. “Bermuda has a long history of innovation so we understand and recognise the power of technology to positively impact both the economy and society,” said Bermuda Premier David Burt. “Over the past two years, we have built on our strength as a global leader in regulating the risks associated with the global insurance industry to develop a clear regulatory framework around managing the risks associated with Fintech. Our progressive approach has drawn accolades

Limelight Networks Expands Developer Toolkit With New API and Portal Enhancements20.8.2019 17:25:00 EESTPress release

Limelight Networks, Inc. (Nasdaq: LLNW), a leading provider of edge cloud services, today announced it has expanded the management and configuration capabilities of its suite of services with new Application Programming Interfaces (APIs) and web portal offerings. With these new capabilities in addition to existing APIs and Software Development Kits, developers now have more power to manage and monitor services across Limelight’s edge cloud platform. According to an IDC surveyi, more than half the organizations surveyed have already adopted DevOps practices, with an additional 20 percent planning to do so in the next 12 months. To help organizations meet these demands, Limelight has introduced expanded API capabilities to provide developers with access to the full set of configuration options available across its content delivery services. Limelight’s new Configuration API enables developers to configure Limelight services and programmatically integrate them into their workflows. It exp

Andersen Global Enters Zimbabwe20.8.2019 16:30:00 EESTPress release

Andersen Global announced it has signed a collaboration agreement with Chimwamurombe Legal Practice (Zenas) in Zimbabwe. Andersen Global has built a presence in over 14 African countries in just under two years. Zenas was founded in 2015 and now has a team of 11 professionals who provide legal services to individuals, organizations, institutions and corporations. With a specialty of serving small to medium enterprises, they offer solutions in mining and construction, commercial, debt recovery, property law, labor law, family law, tax, technology, telecommunications, media and intellectual property law, and criminal litigation. “When we started, we set out to be the most sought-after, trusted legal firm in Zimbabwe,” said Fungai Chimwamurombe, Zenas Office Managing Director. “These values line up very closely with those firms in the Andersen Global international organization. We are happy to join a team of professionals that is equally committed to treating clients like family and deliv

DXC Technology and Google Cloud Announce Global Partnership to Drive Innovation for Enterprises at Scale20.8.2019 16:00:00 EESTPress release

DXC Technology (NYSE: DXC) today announced a strategic partnership with Google Cloud that will enable enterprise clients to modernize their mission-critical IT and integrate digital solutions on Google Cloud Platform. With the strategic partnership, DXC is also launching a Google Cloud Platform Center of Excellence (COE) and a Google Cloud Artificial Intelligence (AI) COE to provide clients in key industries with secure, scalable and agile cloud-based digital platforms that leverage advanced data analytics capabilities. The new collaboration will initially focus on joint solutions in industries such as insurance, oil and gas exploration, automotive, consumer products, retail, and banking and capital markets. Google Cloud now joins the DXC Partner Network as a strategic partner. “Our new Google Cloud partnership will benefit clients looking to go to the next level in their digital transformation,” said Edward Ho, executive vice president and general manager, Offerings, DXC. “Google Clou

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom