Salute e Benessere
Sobi's strength in haematology to be showcased at ASH 2024
Session date: Monday, December 9, 2024,
10:30 AM - 12:00 PM
Presentation time: 11:30 AM
Session date: Monday, December 9, 2024,
10:30 AM - 12:00 PM
Presentation time: 11:00 AM
Session date: Saturday, December 7, 2024,
12:00 PM - 1:30 PM
Presentation Time: 1:00 PM
Session date: Sunday, December 8, 2024
Presentation time: 6:00 PM - 8:00 PM
Session date: Sunday, December 8, 2024
Presentation time: 6:00 PM - 8:00 PM
Session date: Sunday, December 8, 2024
Presentation time: 6:00 PM - 8:00 PM
Session date: Sunday, December 8, 2024
Presentation time: 6:00 PM - 8:00 PM
Session date: Monday, December 9, 2024
Presentation time: 6:00 PM - 8:00 PM
Session date: Sunday, December 8, 2024
Presentation time: 6:00 PM - 8:00 PM
Session date: Sunday, December 8, 2024
Presentation time: 6:00 PM - 8:00 PM
Session date: Monday, December 9, 2024
Presentation time: 6:00 PM - 8:00 PM
Session date: Monday, December 9, 2024,
10:30 AM - 12:00 PM
Presentation time: 11:45 AM
Session date: Saturday, December 7, 2024,
Presentation time: 5:30 PM - 7:30 PM
Session date: Saturday, December 7, 2024,
Presentation time: 5:30 PM - 7:30 PM
Session date: Saturday, December 7, 2024,
Presentation time: 5:30 PM - 7:30 PM
Session date: Sunday, December 8, 2024
Presentation time: 6:00 PM - 8:00 PM
ALTUVOCT® (efanesoctocog alfa) [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] (formerly BIVV001) is the first high-sustained FVIII replacement therapy with the potential to deliver near-normal factor activity levels for a significant part of the week, improving bleed protection in a once-weekly dose for people with haemophilia A. ALTUVOCT builds on the established Fc fusion technology by innovatively adding a region of von Willebrand factor and XTEN® polypeptides to extend its time in circulation. It is the only therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on current factor VIII therapies. The European Commission granted Orphan Drug designation in June 2019 . It is approved and marketed as ALTUVOCT by Sobi in Europe . It is approved and marketed as ALTUVIIIO™ [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl] by Sanofi in the United States , Japan , and Taiwan .
Sobi and Sanofi collaborate on the development and commercialisation of Alprolix® and Elocta®/Eloctate®. The companies also collaborate on the development and commercialisation of ALTUVOCT® (efanesoctocog alfa), or ALTUVIIIO™ in the US. Sobi has final development and commercialisation rights in the Sobi territory (essentially Europe , North Africa , Russia , and most Middle Eastern markets). Sanofi has final development and commercialisation rights in North America and all other regions in the world excluding the Sobi territory.
Gamifant (emapalumab) is an anti-interferon gamma (IFNγ) monoclonal antibody that binds to and neutralises IFNγ. In the USA , Gamifant is indicated for the treatment of adult and paediatric (newborn and older) patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Primary HLH is a rare syndrome of hyperinflammation that usually occurs within the first year of life and can rapidly become fatal unless diagnosed and treated. The FDA approval is based on data from the phase 2/3 studies (NCT01818492 and NCT02069899). Gamifant is indicated for administration through intravenous infusion over one hour twice per week until haematopoietic stem cell transplantation (HSCT).
Vonjo (pacritinib), a JAK-1 sparing JAK2/IRAK1/ACVR1 inhibitor, is approved for the treatment of adults with intermediate- or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 10 /L in the United States . This indication is approved under FDA accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Currently, a Phase 3 study ( PACIFICA ) is being conducted to assess pacritinib in patients with myelofibrosis and severe thrombocytopenia as a post-marketing requirement.
Aspaveli/Empaveli (pegcetacoplan) is a targeted C3 and C3b inhibitor designed to regulate excessive activation of the complement cascade, part of the body's immune system, which can lead to the onset and progression of many serious diseases. Pegcetacoplan is approved for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) as Aspaveli/Empaveli in the United States , European Union, and other countries globally. Currently, a Phase 3 trial (VALIANT) is being conduted to assess the efficacy and safety of pegcetacoplan in patients with C3G and primary IC-MPGN. Aspaveli/Empaveli is also under investigation for several other rare diseases across haematology and nephrology.
Sobi and Apellis have global co-development rights for systemic pegcetacoplan. Sobi has exclusive ex-U.S. commercialisation rights for systemic pegcetacoplan, and Apellis has exclusive U.S. commercialisation rights for systemic pegcetacoplan and worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy.
Doptelet (avatrombopag) is an orally administered thrombopoietin receptor agonist (TPO-RA) that mimics the biologic effects of TPO in stimulating the development and maturation of megakaryocytes, resulting in increased platelet count. It is approved in over 30 countries worldwide, including the EU and the US, for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure, and for the treatment of thrombocytopenia in adult patients with primary chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Chronic ITP is a rare autoimmune bleeding disorder characterised by low number of platelets. The incidence of primary ITP in adults is 3.3/100,000 adults per year with a prevalence of 9.5 per 100,000 adults.
Sobi® is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology, and specialty care, Sobi has approximately 1,800 employees across Europe , North America , the Middle East , Asia , and Australia . In 2023, revenue amounted to SEK 22.1 billion . Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.
For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here.
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https://news.cision.com/swedish-orphan-biovitrum-ab/r/sobi-s-strength-in-haematology-to-be-showcased-at-ash-2024,c4074709
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