Octapharma Share Promising Preclinical Data for SubQ-8, a Novel Subcutaneous Recombinant FVIII, at WFH 2018
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”.
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%.
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
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Morinaga Milk Study Suggests Infant-Type Human-Residential Bifidobacteria May Benefit Infant Health by Improving Digestion of Peptides in Milk and Grains23.10.2018 18:00 | Pressemelding
Scientists at Morinaga Milk Industry Co., Ltd. (TOKYO:2264) have long theorized that Human-Residential Bifidobacteria (HRB) are superior to non-Human-Residential Bifidobacteria (non-HRB) in promoting good health outcomes. The results of a new study strengthen the evidence for this theory, showing that infant-type HRB may be able to break down incompletely digested peptides in the infants’ gastrointestinal systems and thus contribute to their overall health. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181023005015/en/ Fig 1. Food-derived opioid peptides are potential risk factors for human health (Graphic: Business Wire) Human-Residential Bifidobacteria for Humans Morinaga Milk has been conducting research on bifidobacteria for many years, and studies over the past decades have shown that bifidobacteria play a vital role in various aspects of human health. There are two major groups of bifidobacteria: Human-Residential Bif
myPOS Founder Christo Georgiev Announces Two Upcoming myPOS Stores in Barcelona and Paris23.10.2018 16:22 | Pressemelding
Christo Georgiev, fintech entrepreneur and founder of myPOS, has confirmed his intention to open two new flagship stores in major European cities by the end of the year. The opening is part of an initiative to bring the product closer to potential customers, giving them a hands-on experience and a live demonstration of what myPOS has to offer. The two new stores will be opened in Barcelona, Spain and Paris, France – two of the most important markets for myPOS. “Our Spanish and French customers have always placed a tremendous amount of trust in us, and we in turn have worked hard to justify it,” Georgiev says. “Opening physical locations in Barcelona and Paris is an extension of that relationship. It’s important to test a product with your own hands before you choose to trust it, and if that’s true for TVs and phones why can’t it apply to POS terminals?” The Barcelona store will open as soon as November, followed shortly by the Paris one before the end of the year. myPOS has already ope
Christo Georgiev Announces the Arrival of myPOS AppMarket23.10.2018 16:11 | Pressemelding
myPOS Europe Ltd., a leading card payments provider to small and medium-sized businesses in Europe, is introducing its own AppMarket – an innovative software platform for business applications that allows myPOS clients to find, download and use various apps for improved business performance. The development of myPOS AppMarket was driven by the necessity to meet the ever-changing business needs dictated by customer demand and behaviour. While the payment terminals myPOS offers come with a large number of innovative payments features, there are other business needs which remain uncaptured at the moment. myPOS founder Mr. Christo Georgiev says: “Individual businesses need a tailored approach when it comes to accepting payments for their services. Offering a fully customizable and complete omni-channel payments solution, which empowers businesses to stay agile, has always been in our foresight. Tapping into the familiarity of our everyday favourite device – the smartphone, pushed us even f
CNIM Presents a Rapid Version of The LCAT® Shore-to-Shore Featuring Unique Operational Capabilities23.10.2018 15:45 | Pressemelding
The L-CAT® Shore-to-shore presented by CNIM at Euronaval 2018 delivers a major increase in performance for amphibious missions. The L-CAT® Shore-to-shore has been upgrated since its launch 2 years ago. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181023005869/en/ CNIM's amphibious craft, the L-CAT® Shore-to-shore (Photo: CNIM) The L-CAT® Shore-to-shore is now the only vessel with the ability to transport 80 tonnes at 25 knots in conditions up to sea state 5, land in shallow water (~1m) and accommodate 42 passengers for long distance trips. Highly maneuvrable, the L-CAT® Shore-to-shore provides exceptional operational flexibility for amphibious assaults and humanitarian operations, without compromising between speed and payload. Its wide loading platform (145 m²), ability to travel up to 800 nautical miles when loaded, self-defence and communication capabilities are tactical advantages for the projection of Forces. Its spee
Exterior Plus, a Portfolio Company of H.I.G. Capital, Acquires Impactmedia23.10.2018 13:03 | Pressemelding
Exterior Plus, the out-of-home advertising platform of H.I.G. Capital, announces the acquisition of Impactmedia (the “Company”), a leading shopping mall advertising company, with over 630 million viewers in high-traffic premium locations throughout Spain. This is a major step forward in Exterior Plus’s consolidation strategy, as it aims to become the Spanish leader in out-of-home advertising with a unique, diversified and highly-competitive product portfolio, reaching very diverse audiences at a national level. Impactmedia is an experienced leader in shopping mall advertising, offering digital advertising as well as special marketing actions. The Company operates in over 90 shopping centers where it has more than 1,200 digital displays. The acquisition allows Exterior Plus to gain a strong presence near points of sale, a key value driver for advertisers. H.I.G. Capital acquired and established the Exterior Plus group in December 2015. The group currently markets more than 25,000 advert
Visa Brings a Simpler, Safer Experience to Digital Payments23.10.2018 13:00 | Pressemelding
Visa (NYSE: V) today announced a continued commitment to reducing friction and improving security in digital commerce by reiterating support of the draft EMV® Secure Remote Commerce (SRC) Specification. The draft EMV SRC Specification provides a foundation for digital transactions that gives consumers, merchants and issuers a single digital point-of-sale, resulting in a consistent, convenient and secure way to pay. EMVCo has spent the last year gathering feedback from across the payment ecosystem on the specification. Visa now encourages merchants, issuers, acquirer gateways and other interested participants to provide feedback and comment during a 45-day public comment window. Once complete, EMVCo will publish the final specification. Shoppers are increasingly migrating to websites, mobile phones and voice-activated devices, but their buying experiences are full of friction because they are required to manually enter payment details. With SRC, consumers’ digital buying experiences wil