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

Andersen Global Expands UK Locations23.5.2019 16:30:00 EESTTiedote

Claritas Tax Limited, a Birmingham, United Kingdom-based collaborating firm of Andersen Global, has opened a new office location in Deansgate, Manchester city center. This means that Andersen Global now has a presence in six locations in the UK through its member firms and collaborating firms. “Now more than ever, it’s important that businesses have easy access to quality advice in the UK’s dynamic political and business environment. The addition of another location in the region adds to our existing capabilities and will allow us to continue providing best-in-class service,” said Mark Vorsatz, Andersen Global Chairman and CEO of Andersen Tax LLC. Founded in 2012, Claritas Tax Limited has a list of clientele from entrepreneurial, privately owned, venture capital, and private equity owned businesses, listed companies and stakeholders. Claritas provides a broad range of tax consulting services, including all aspects of M&A and transactional taxes, R&D and Intellectual Property claims, sh

Mindbreeze Receives Attestation in Accordance with BSI Cloud Requirements23.5.2019 16:11:00 EESTTiedote

Mindbreeze receives attestation for its Mindbreeze InSpire SaaS service according to the specifications of the C5 catalogue of requirements (Cloud Computing Compliance Controls Catalogue, abbreviated C5), published by the German Federal Office for Information Security (BSI). The Mindbreeze InSpire SaaS service is professionally operated in Mindbreeze data centers on behalf of the customers. The attestation was issued by KPMG Alpen-Treuhand GmbH Wirtschaftsprüfungs- und Steuerberatungsgesellschaft. “The number of cloud services in the field of data analysis is growing steadily. This makes it all the more essential for customers to take a closer look at the choice of suppliers. C5 provides the regulatorily defined IT security level, which is comparable to the IT basic protection level that is increased by cloud controls,” explains Klaus Schatz, Managing Director of KPMG Advisory GmbH. C5 attestation (ISAE 3000 Report Type 2) is a recognized and authoritative verification for all customer

Bacardi Limited Announces 5th Annual Good Spirited Awards for Employee-Led Global Environmental Sustainability Programs23.5.2019 15:15:00 EESTTiedote

In continuation of its ongoing sustainability efforts, Bacardi Limited is proud to announce the recipients of its 5th annual Bacardi Limited Good Spirited Awards. Launched in 2014, the awards recognize the employees, teams and facilities across the company’s global network that developed the best environmental programs across five different categories: Production Facility, Brand Innovation, Sustainable Office, Green Champions or Partnerships. This year’s winners instituted programs to shift to renewable energy, reduce water use and waste, increase recycling efforts and amplify the Bacardi Limited No Straws campaign to decrease the amount of single-use plastic straws by one billion over the next two years. The awards acknowledge activities that took place between April 1, 2018 and March 31, 2019. “Bacardi Limited’s Good Spirited Awards truly underscore the company’s foundation and support of global environmental sustainability efforts at our facilities and in our communities,” says Rick

Teridion Announces Deep Integration with Cisco Meraki MX Security and SD-WAN Appliances to Deliver New High Performance Internet Service23.5.2019 15:00:00 EESTTiedote

Teridion, the company delivering the only global public cloud-based WAN service, today announced its deep integration with Cisco Meraki MX Security and SD-WAN appliances. The combined solution is a bold new approach to branch networking, delivering the industry-leading Auto VPN and SD-WAN capabilities of Cisco Meraki’s MX appliances with Teridion’s high throughput and low latency public cloud-based WAN service. For the first time, enterprises can take advantage of a WAN solution that has visibility and control of first, middle, and last mile of the Internet and extends SD-WAN and WAN acceleration beyond enterprise sites to include SaaS applications and enterprise cloud workloads across multiple public cloud providers. Today’s announcement highlights the new, seamless network level integration between Teridion’s high performance cloud WAN service and Cisco Meraki’s easy-to-use Auto VPN routing and high availability capabilities. Enterprise of all sizes can expect real-time applications

C.H. Robinson Acquires Dema Service S.p.A. to Expand Global Presence23.5.2019 14:00:00 EESTTiedote

C.H. Robinson (NASDAQ: CHRW) continues to expand its global footprint with its announcement of the acquisition of Dema Service S.p.A. (Dema Service) on May 22, 2019. Dema Service is a leading provider of European road transportation based in Italy. “The acquisition of Dema Service is an exciting milestone for C.H. Robinson and will strengthen our existing footprint in Italy, one of the largest road transportation markets in Europe,” said Jeroen Eijsink, President of Europe for C.H. Robinson. “We are eager to work with Dema Service’s customers to offer our full suite of logistics services to help improve their supply chains.” This is the second European acquisition for C.H. Robinson in 2019. The company recently acquired the freight forwarding group Space Cargo, which expanded C.H. Robinson’s presence in Spain and Columbia. Dema Service is a privately-owned logistics company providing road transportation services across Europe. Headquartered in Pescara, Italy, Dema Service has approxima

Rapid Multiplexing with Opal® Research Kits Now Available on LabSat™ Platform23.5.2019 13:30:00 EESTTiedote

Lunaphore Technologies S.A., a Swiss medtech firm developing innovative next-generation equipment for cancer research and tissue diagnostics, announces a new rapid multiplexing application for its LabSat™ Research instrument. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190523005082/en/ FFPE IF of tonsil, 6-plex + DAPI. Total staining time: 4h12 (with Opal® 7-Color Manual IHC Kit) (Photo: Business Wire) Following the signature of a co-marketing agreement between Lunaphore Technologies S.A. and Akoya Biosciences, Inc.; Lunaphore will start providing multiplexing protocols using Akoya’s Opal® immunoassay kits for its staining platform LabSat™ Research, Lunaphore’s first solution to reach the market. LabSat™ is shown to perform rapid tests on tissue samples under 2.5 hours for a 3-plex plus counterstaining with the Opal® 4-Color Manual IHC Kit; and under 4.5 hours for a 6-plex plus counterstaining with the Opal® 7-Color Manua

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