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
Scania’s New Intelligent C-me Vest on Display at MWC Barcelona by Imagimob and Light Flex20.2.2019 07:30:00 | Pressemelding
Imagimob is pleased to announce that attendees of this year’s Mobile World Congress will get the chance to see Scania’s groundbreaking C-me safety vest, which officially hits the market this year. The intelligent and highly visible vest combines Imagimob Edge AI software with a unique active light technology system by Light Flex. The connected and intelligent C-me safety vest keeps a protective hand over truck drivers during work around vehicles. If something goes wrong—for example, the driver suddenly falls or becomes immobilized—a call for help is automatically triggered. Pre-assigned contacts are notified and sent GPS coordinates, and attention is immediately drawn to the driver through flashing light indicator activity. By using data from embedded sensors, Imagimob AI instantaneously analyzes the motion of the driver, lights up the vest whenever the driver exits the truck, and sends a signal when help is needed. The result is a considerable safety boost for truck drivers, who typic
Sonitor® Technologies AS Spins-Out Forkbeard as Subsidiary and Establishes New Corporate Structure20.2.2019 07:00:00 | Pressemelding
The Board of Directors of Sonitor Technologies AS announced today that it is establishing Sonitor IPS Holding AS (Indoor Positioning Systems) and creating two subsidiaries; Sonitor Technologies AS and Forkbeard Technologies AS. Forkbeard Technologies will focus on the development of platform technologies for cloud-based, indoor positioning of mobile devices. Sonitor Technologies will continue to focus on the commercialization and expansion of the market leading Sonitor Sense™ platform and will partner in the commercialization of the Forkbeard™ technology platform in healthcare and other markets. “After careful consideration, the Board of Directors has determined that separating Sonitor into two independent entities will accelerate the growth and development of each and lead to greater shareholder value,” said Carl Christian Gilhuus-Moe, PhD, Executive Chairman, Sonitor Technologies AS. “The current Sonitor Board of Directors will continue as the board of directors for Sonitor IPS Holdi
Traxens Gains Confidence of Tens of Top 500 Beneficial Cargo Owners20.2.2019 07:00:00 | Pressemelding
Traxens, expert in providing high-value data and services for the supply chain industry, today announces that it signed several contracts with some of the top 500 Beneficial Cargo Owners (BCO), including major companies such as BASF. Under the terms of the agreements, Traxens provides door-to-door data monitoring solutions for smart containers supplied by partnering shipping lines. BCOs are typically industrial companies importing and exporting large volumes of goods in containers. Traxens’ customers operate in various industries such as aeronautics, pharmaceuticals, chemicals, automotive and foods. These firms require cutting-edge data monitoring systems for easy and reliable management of stocks, actionable analytics and cost reductions. Traxens’ Supply Chain Diagnostic solution enables near real-time monitoring with custom alerts through its web application Traxens-Hub or direct back-end integration, as well as bespoke analysis of transportation performance, thus enabling process op
IFF Acquires The Additive Advantage; Expands Scent, Taste, and Actives Delivery Capabilities19.2.2019 21:15:00 | Pressemelding
Regulatory News: International Flavors & Fragrances Inc. (NYSE: IFF) (Euronext Paris: IFF) (TASE: IFF), has expanded and strengthened its innovation capabilities for scent, taste and active ingredients through the acquisition of The Additive Advantage (TAA), a company that develops novel technologies with diverse capabilities that span applications and industries. TAA has the expertise to develop the next-generation delivery systems technology platform that will enable the printing of flavors, fragrances, cosmetic and health & nutrition actives onto a variety of consumer products. IFF Chairman & CEO Andreas Fibig said, “The acquisition of TAA helps to expand our large portfolio of offerings to customers in a truly unique way – through print technology. With the expertise that this talented group of people brings under our roof, we envision taking delivery systems to a completely new level and ultimately enriching how consumers experience our customers’ products.” “We are genuinely exci
Guidewire Software Announces Hexaware as New Consulting Alliance Partner19.2.2019 21:15:00 | Pressemelding
Hexaware Technologies, a fast growing automation-led, next generation provider of IT, BPO and consulting services, and Guidewire Software, Inc. (NYSE: GWRE), provider of the industry platform Property and Casualty (P&C) insurers rely upon, today announced that Hexaware has joined Guidewire PartnerConnect™ as a Consulting alliance member at the Select level. With over 20 years’ experience working with P&C insurers, Hexaware has developed value-add solution and technology offerings that enable insurers to rapidly adopt Guidewire InsuranceSuite™ and Guidewire Digital products, increasing speed to implementation, mitigating execution risk, and lowering costs. Hexaware has supported Guidewire customer success in APAC and EMEA and offers localized solutions for insurers in these regions. “Digital technology is disrupting the P&C insurance industry at an unprecedented rate, and insurers are leveraging market-leading platforms, such as Guidewire InsurancePlatform™, to deliver differentiated pr
Rockwell Automation and Schlumberger Enter Joint Venture Agreement to Create Sensia, the Oil and Gas Industry’s First Fully Integrated Automation Solutions Provider19.2.2019 21:05:00 | Pressemelding
Rockwell Automation (NYSE: ROK), the world’s largest company dedicated to industrial automation and information, and Schlumberger (NYSE: SLB), the world's leading provider of technology for reservoir characterization, drilling, production, and processing to the oil and gas industry, announced today that they have entered into an agreement to create a new joint venture, Sensia, the first fully integrated digital oilfield automation solutions provider. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190219005851/en/ The transaction is expected to close, and the joint venture is expected to begin serving customers, in the summer of 2019, subject to regulatory approvals and other customary conditions. The Sensia joint venture will be the first fully integrated provider of measurement solutions, domain expertise, and automation to the oil and gas industry. It will offer scalable, cloud and edge-enabled process automation, includin