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Beskrivning

LandSverige
ListaLarge Cap Stockholm
SektorHälsovård
IndustriLäkemedel & Handel
Swedish Orphan Biovitrum, även kända under namnet Sobi, är ett internationellt läkemedelsbolag. Störst inriktning återfinns inom tillhandahållandet av innovativa behandlingar och service för patienter med sällsynta sjukdomar. Produkterna som bolaget utvecklar fokuserar på inflammatoriska- samt genetiska sjukdomar. Sobi marknadsför även särskilda specialist- och sårläkemedel under olika varumärken. Huvudkontoret ligger i Stockholm.
2024-01-31 07:00:00

Sobi® will present new data at the 17th European Association of Haemophilia and Allied Disorders (EAHAD) conference in Frankfurt from 6-9 February 2024. The studies that will be presented support Sobi's ongoing commitment to evolving treatment options for people with haemophilia.

"We are proud to showcase new data at EAHAD 2024, including several new data sets that add to the substantial evidence supporting the use of efanesoctocog alfa in children and highlighting improvements in patient-reported outcomes. Our hope is that these advancements will open new possibilities for people with haemophilia," said Lydia Abad-Franch, Head of R&D and Chief Medical Officer at Sobi. "We will also present further data reinforcing the comprehensive evidence supporting the safety and effectiveness of Elocta® and Alprolix®. Sobi's involvement at EAHAD underscores our continued dedication to advancing knowledge and raising standards of care."
 

Key Sobi data to be presented at EAHAD 2024

+---------------------+------------------+------------------------------------+
|Efanesoctocog Alfa - |Effective |Oral presentation number: OR12 |
|Joint Sobi/Sanofi |protection with | |
| |once-weekly | |
| |efanesoctocog alfa| |
| |in children: | |
| |Secondary analyses| |
| |of | |
| |pharmacokinetics | |
| |and bleeds from | |
| |the XTEND-Kids | |
| |trial | |
+---------------------+------------------+------------------------------------+
|Efanesoctocog Alfa - |Efanesoctocog Alfa|Poster presentation number: |
|Joint Sobi/Sanofi |Prophylaxis |PO113 |
| |Outcomes in | |
| |European Patients | |
| |From the XTEND-1 | |
| |Trial | |
+---------------------+------------------+------------------------------------+
|Efanesoctocog Alfa - |Clinical overview |Poster presentation number: |
|Joint Sobi/Sanofi |of perioperative | |
| |outcomes from the |PO050 |
| |XTEND-Kids study | |
+---------------------+------------------+------------------------------------+
|Efanesoctocog Alfa - |Treatment |Poster presentation number: |
|Joint Sobi/Sanofi |Preferences in |PO123 |
| |Previously Treated| |
| |Patients with | |
| |Haemophilia A: | |
| |Phase 3 XTEND-1 | |
| |Study of | |
| |Efanesoctocog Alfa| |
+---------------------+------------------+------------------------------------+
|Efanesoctocog Alfa - |Quality of Life in|Poster presentation number: |
|Joint Sobi/Sanofi |Children with |PO134 |
| |Haemophilia A: | |
| |Phase 3 XTEND-Kids| |
| |Study of | |
| |Efanesoctocog Alfa| |
+---------------------+------------------+------------------------------------+
|Efanesoctocog Alfa - |Systematic |Poster presentation number: |
|Joint Sobi/Sanofi |literature review |PO184 |
| |to evaluate | |
| |haemophilia A | |
| |therapies in | |
| |paediatric | |
| |patients without | |
| |inhibitors | |
+---------------------+------------------+------------------------------------+
|Elocta®/Eloctate® |Immune Tolerance |Poster presentation number: |
|(efmoroctocog alfa) -|Induction with a |PO103 |
|Sobi |Recombinant Factor| |
| |VIII Fc in | |
| |Haemophilia A: | |
| |Final Data from a | |
| |Chart Review Study| |
+---------------------+------------------+------------------------------------+
|Elocta®/Eloctate® |Real-world |Poster presentation number: |
|(efmoroctocog alfa) -|effectiveness and |PO085 |
|Sobi |safety of a | |
| |recombinant Factor| |
| |VIII Fc in | |
| |patients with | |
| |haemophilia A by | |
| |age groups: Pooled| |
| |analysis (A | |
| |-SURE/PREVENT) | |
+---------------------+------------------+------------------------------------+
|Elocta®/Eloctate® |Real-world |Poster presentation number: |
|(efmoroctocog alfa) -|effectiveness and |PO099 |
|Sobi |safety of a | |
| |recombinant Factor| |
| |VIII Fc in | |
| |patients with | |
| |haemophilia A by | |
| |disease severity: | |
| |Pooled analysis (A| |
| |-SURE/PREVENT) | |
+---------------------+------------------+------------------------------------+
|Alprolix® |Real-World |Poster presentation number: |
|(eftrenonacog alfa) |Effectiveness and |PO068 |
|- Sobi |Usage of | |
| |Recombinant Factor| |
| |IX Fc: Secondary | |
| |Paediatric | |
| |Analysis from the | |
| |24-Month French, | |
| |Prospective, Non | |
| |-Interventional B | |
| |-SURE Study | |
+---------------------+------------------+------------------------------------+
|Alprolix® |Interim Analysis |Poster presentation number: |
|(eftrenonacog alfa) |of Real-World |PO043 |
|- Sobi |Effectiveness and | |
| |Usage of | |
| |Recombinant Factor| |
| |IX Fc for Surgical| |
| |Haemostasis from | |
| |the 24-Month | |
| |Prospective, Non | |
| |-Interventional B | |
| |-MORE Study | |
+---------------------+------------------+------------------------------------+
|Alprolix® |Real-World |Poster presentation number: |
|(eftrenonacog alfa) |Effectiveness and |PO127 |
|- Sobi |Usage of | |
| |Recombinant Factor| |
| |IX Fc: Interim | |
| |Analysis in | |
| |Paediatric | |
| |Patients from the | |
| |24-Month, | |
| |Prospective, Non | |
| |-Interventional B | |
| |-MORE Study | |
+---------------------+------------------+------------------------------------+
|Haemophilia |Physical Activity |Poster presentation number: |
| |Awareness Among |PO299 |
| |People with |Session date and time: |
| |Haemophilia and | |
| |their Caregivers |6 February 2024, from 12:00 to 20:30|
| |in Central Europe | |
+---------------------+------------------+------------------------------------+

All presentations can be accessed via theofficial EAHAD 2024 website (https://eahadcongress.com/?utm_source=google&utm_medium=ads&utm_campaign=registration&gad_source=1&gclid=Cj0KCQiA2KitBhCIARIsAPPMEhIxVQely6kXQETGRcTO3NZFvUXTZOHOYk_wCDnEitpkj78pyxFHlMoaAltsEALw_wcB).

About efanesoctocog alfa

Efanesoctocog alfa [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] (formerly BIVV001) is a new class and investigational recombinant factor VIII therapy with the potential to deliver near-normal factor activity levels for a significant parts of the week, improving bleed protection in a once-weekly dose for people with haemophilia A. Efanesoctocog alfa builds on the innovative Fc fusion technology by 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. 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. The European Commission granted Orphan Drug designation in June 2019, and the European Medicines Agency accepted the Marketing Authorisation Application (MAA)for efanesoctocog alfa in May 2023.

About Elocta®/Eloctate®

Elocta®/Eloctate® (efmoroctocog alfa) is a recombinant clotting factor therapy developed for haemophilia A using Fc fusion technology to prolong circulation in the body. It is engineered by fusing factor VIII to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body), enabling Elocta to use a naturally occurring pathway to extend the time the therapy remains in the body (half-life). Elocta is manufactured using a human cell line in an environment free of animal and human additives. Elocta is approved and marketed by Sobi for the treatment of haemophilia A in the EU, the UK, Iceland, Kuwait, Liechtenstein, Norway, Saudi Arabia and Switzerland. It is approved and marketed as Eloctate® (Antihemophilic Factor [Recombinant], Fc Fusion Protein) by Sanofi in the United States, Canada, Japan, Australia, New Zealand and other countries, where Sanofi has the marketing rights.
 

About Alprolix®
Alprolix® (eftrenonacog alfa) is a recombinant clotting factor therapy developed for haemophilia B using Fc fusion technology to prolong circulation in the body. It is engineered by fusing factor IX to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body), enabling Alprolix to use a naturally occurring pathway to extend the time the therapy remains in the body (half-life). Alprolix is manufactured using a human cell line in an environment free of animal and human additives. Alprolix is approved and marketed by Sobi for the treatment of haemophilia B in the EU, the UK, Iceland, Kuwait, Liechtenstein, Norway, Saudi Arabia and Switzerland. It is also approved in the United States, Canada, Japan, Australia, New Zealand and other countries where Sanofi has the marketing rights.

About the Sanofi and Sobi collaboration
Sobi and Sanofi collaborate on the development and commercialisation of Alprolix® and Elocta®/Eloctate®. The companies also collaborate on the development and commercialisation of 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.

Sobi®
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 2022, revenue amounted to SEK 18.8 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com,LinkedIn (https://www.linkedin.com/company/sobi/)andYouTube (https://www.youtube.com/c/Sobi-Pharma).

Contacts
For details on how to contact the Sobi Investor Relations Team, please click here (https://www.sobi.com/en/investors). For Sobi Media contacts, clickhere. (https://www.sobi.com/en/media)