Business Wire

Octapharma Share Promising Preclinical Data for SubQ-8, a Novel Subcutaneous Recombinant FVIII, at WFH 2018

Jaa

Octapharma announced today that pre-clinical data for SubQ-8 were presented during a symposium at the recent World Federation of Hemophilia (WFH) 2018 World Congress in Glasgow, UK. SubQ-8, currently under development, is a recombinant FVIII from a human cell line for subcutaneous administration. SubQ-8 is based on Octapharma’s human cell line-derived rFVIII product simoctocog alpha combined with a fragment of the von Willebrand Factor (VWF) protein, and harnesses the protective power of VWF in an innovative approach to facilitate transportation of FVIII into the circulation.

Regular intravenous administration of FVIII poses a considerable burden to people with haemophilia A and their families. Alternative routes of administration may help to alleviate some of this burden and improve adherence to prophylaxis therapy.

This symposium, entitled ‘Taking FVIII into the future: The development of subcutaneous recombinant human FVIII for the treatment of haemophilia A’, reviewed the challenges that intravenous administration poses to people with haemophilia A on a daily basis, and presented data on the uptake of SubQ-8 into the vasculature following subcutaneous administration in animal models.

David Lillicrap (Queens University, Ontario, Canada) chaired the symposium and introduced the relevance of SubQ-8 within the rapidly advancing haemophilia treatment field. Cedric Hermans (Saint-Luc University Hospital, Brussels, Belgium) discussed the important role of FVIII, and the use of FVIII therapy as a natural approach to restoring blood clotting in haemophilia A. The proven benefits of FVIII prophylaxis include protecting from devastating intracranial bleeds and reducing the risks of long term joint damage. Dr Hermans also presented the challenges and burdens of intravenous infusion of FVIII, which may present a hurdle to initiating and adhering to prophylaxis. As a result, there is demand for a simpler FVIII administration method.

Christoph Kannicht (Octapharma Research & Development, Berlin, Germany) explained the rationale for the development of SubQ-8, and addressed the challenge of achieving sufficient FVIII bioavailability after subcutaneous infusion. Pre-clinical data in the animal models showed 45.5% bioavailability of FVIII after subcutaneous administration of SubQ-8, and a 3.6-fold prolongation of FVIII half-life compared with FVIII intravenous infusion. Andreas Tiede (Hannover Medical School, Hannover, Germany) addressed the immunogenicity risk of protein therapeutics administered subcutaneously or intravenously, concluding that there is no evidence for a difference in risk. The immunogenicity of SubQ-8 has been studied in mice and subcutaneous administration of SubQ-8 resulted in a slower development of anti-FVIII antibodies than intravenous administration of FVIII.

The data presented represent a promising basis for future clinical studies of SubQ-8. Larisa Belyanskaya, Head of Octapharma’s IBU Haematology, said “WFH was a fantastic platform to share the most recent data on the development of our new subcutaneous FVIII product, SubQ-8. We at Octapharma believe that SubQ-8 could play an important role in ensuring patients receive optimal treatment for haemophilia A”. Olaf Walter, Board Member of Octapharma, added that “Octapharma is committed to improving patients’ lives and we are proud to be developing a product with such potential for the haemophilia field. Presenting our preclinical data at WFH is an important step in realising our goal”.

About SubQ-8

SubQ-8 is Octapharma’s developmental rFVIII product for subcutaneous administration, currently in the preclinical stage.

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

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

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 ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

REPLY Study on Artificial Intelligence: Quo vadis, AI?23.1.2019 13:00Tiedote

Artificial intelligence enable machines to better understand the surrounding context, giving them the ability to recognise sight, sound and speech. This is made possible by machine learning algorithms. A current study by Reply, conducted with the trend platform SONAR, shows which trends are still relevant in this area. The study highlights some aspects of the future potential of Artificial Intelligence (AI). Complex algorithms, Edge Computing tools that reduce latency periods and AI-specific hardware are yielding many new products and services for mobile computing, the Internet of Things (IoT) and Human-machine Interfaces. There are many different possible scenarios, and three trends play a major role in determining AI’s future as a game changer: AI-driven analytics In the era of digital transformation, decisions are made based on data with the help of predictive analytics. Companies in diverse industries use AI-as-a-service solutions from established providers or start-ups and increas

GSMA Announces Nominees for 2019 GLOMO Awards23.1.2019 12:00Tiedote

The GSMA today announced the nominees for the Global Mobile Awards 2019 (GLOMO Awards). Winners of the awards will be presented throughout MWC19 Barcelona, which takes place 25 - 28 February. The full list of nominees can be found at www.mwcbarcelona.com/conference-programmes/global-mobile-awards/global-mobile-awards-2019-nominee-shortlist/. “The GLOMOs provide a world stage on which to celebrate the most inspirational and innovative developments across our industry, recognising the companies and individuals leading the way in everything from 5G, to emerging markets, to intelligent connectivity,” said John Hoffman, CEO, GSMA Ltd. “The awards attract a significant level of high-quality entries, so being nominated today is a great achievement. We wish everyone the very best of luck and we look forward to some exciting announcements at MWC19 Barcelona.” The GLOMO Awards feature an afternoon ceremony at 16:30 CET on Tuesday, 26 February in Auditorium 5, Hall 4, and will include the present

Y Analytics Launches to Bring Together Capital and Research for Good23.1.2019 11:58Tiedote

Today marks the launch of Y Analytics, a new, independent organization established to drive increased and more effective investment in creating social and environmental good by equipping capital allocators with the research basis to effectively understand the impact of their decisions. The organization, headquartered in Washington, D.C. and led by Maryanne Hancock, will help bridge the divide between the research community and capital allocators. Ultimately, this will ensure that capital directed at addressing the United Nations Sustainable Development Goals is used most efficiently, and more broadly, that we advance our abilities to direct capitalism towards solutions that have the potential to create real, tangible impact. From Maryanne Hancock, CEO of Y Analytics: “We are building on the extensive effort of others, who have worked for decades to advance the world’s understanding of what creates impact. Y Analytics is built on the premise of learning from their work, utilizing resear

SpeeDx Increase European Distribution Network23.1.2019 11:00Tiedote

SpeeDx have announced signing two new distribution partners, creating comprehensive access for customers to market-leading SpeeDx ResistancePlus ® and PlexPCR ® tests across Europe. AB ANALITICA will distribute throughout Italy and Immuno Diagnostic Oy will cover Finland. “Our new distribution partners have strong sales presence in their regions and close working relationships with the key customers that are interested in our solutions,” says Colin Denver, SpeeDx CEO. “Antibiotic resistance in sexually transmitted diseases is a top concern for authorities and testing bodies across Europe, and now more laboratories can access our ResistancePlus tests for Mycoplasma genitalium and gonorrhoea to help address the real need for Resistance Guided Therapy.” The SpeeDx ResistancePlus portfolio includes ResistancePlus GC* (CE-IVD) - the first commercially available test that combines Neisseria gonorrhoeae (GC) detection with markers for ciprofloxacin susceptibility. ResistancePlus GC enables st

Nikon, ASML And Carl Zeiss Sign Agreement to Settle All Litigation23.1.2019 10:02Tiedote

Nikon Corporation (“Nikon”) (TYO: 7731), ASML Holding N.V. (“ASML”) (NASDAQ: ASML) and Carl Zeiss SMT GmbH (“Zeiss”) have signed a Memorandum of Understanding relating to a comprehensive settlement of all legal proceedings over patents for lithography equipment and digital cameras. The Memorandum of Understanding is a binding agreement that concerns all pending disputes between Nikon, ASML and Zeiss in Europe, Japan and the United States, including at the U. S. International Trade Commission. The three companies expect to execute a definitive settlement and cross-license agreement and dismiss all legal proceedings between the parties in February 2019. The terms of the Memorandum include a payment to Nikon by ASML and Zeiss of a total of EUR 150 million (approximately 19.0 billion Japanese Yen*). Furthermore, the cross-license agreement contemplated by the Memorandum includes mutual royalty payments of 0.8% over the sales of immersion lithography systems for 10 years from the signature

PMI Explores Global Public Health Issues in New White Paper23.1.2019 10:00Tiedote

In a new White Paper, “Public Health—Much Harder than Rocket Science,” Philip Morris International (PMI) (NYSE:PM) looks at the dynamics between consumers, corporations and authorities across a range of global public health issues. It is based on a recent global survey conducted by IPSOS. Consumers all over the world want their governments to do better at solving major public health issues, according to the IPSOS survey of 31,000 respondents across 31 countries commissioned by PMI. In the survey, respondents were asked how important they believed it is for governments to dedicate time and resources to nine global health issues: air pollution, mental health, STDs, healthier food products, opioid abuse, smoking and alcohol abuse, unwanted pregnancies and obesity. When asked about the role of technology and innovation in addressing these issues, 91 per cent of respondents believed technology and innovation had an important role to play. However, respondents did not evaluate government per

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