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  • Gerard Tobin

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    Switching to extended half-life prophylaxis impacted clinical outcomes and improved quality of life for people with haemophilia A or B

    Clinical study data on switching haemophilia A and B patients from on-demand treatment to extended half-life (EHL) prophylaxis showed a positive impact on clinical outcomes, with improvements in quality of life (QoL) and reduced annual bleeding rates (ABR). The results of these joint studies by Sobi™  and Sanofi were presented at ISTH 2019, the 27th Congress of the International Society on Thrombosis and Haemostasis, in Melbourne, Australia, on 7, 8 and 9 July 2019. “This data supports the observation that the introduction of EHLs has allowed for people with

    Interim data evaluating Elocta® for Immune Tolerance Induction in people with inhibitors and severe haemophilia A shared at ISTH 2019

    Interim results from verITI-8, an ongoing prospective, phase 4 study evaluating the efficacy of Elocta® (efmoroctocog alfa), for first-time Immune Tolerance Induction (ITI) for people with severe haemophilia A with inhibitors were presented today. These early data from the joint SobiTM  and Sanofi study in this investigational setting were shared in an oral session at the XXVII Congress of the International Society on Thrombosis and Haemostasis (ISTH). The development of inhibitors, or antibodies, to FVIII replacement therapy is one of the most serious complications

    Sobi presents study data supporting increased possibilities and improved clinical outcomes for people with haemophilia at ISTH

    Sobi™ presents data at the ISTH 2019: The 27th Congress of the International Society on Thrombosis and Haemostasis, Melbourne, Australia, 6 – 10 July 2019, focusing on the use of Elocta® and Alprolix® in clinical settings such as treatment switches from on demand to prophylaxis and immune tolerance induction (ITI). The reported outcomes include annualised bleeding rates, quality of life as well as joint health. It will be the first time interim results from the global, prospective verITI-8 study of rFVIIIFc for first-time ITI will be presented. We will also present data showing the pain and

    Individualised extended half-life factor replacement therapy controls haemostasis in orthopaedic surgery

    Today, Sobi™  and Sanofi will present data demonstrating that Elocta® (efmoroctocog alfa) and Alprolix® (eftrenonacog alfa) can provide perioperative haemostatic control across a wide spectrum of major and minor surgeries in subjects of all ages with severe haemophilia A and B respectively. The presentation will take place at the World Federation of Hemophilia’s 16th International Musculoskeletal Congress (MSK) 10-12 May 2019, in Madrid, Spain. One of the major complications for people living with haemophilia is recurrent bleeding into joints and subsequent

    Sobi publishes report for first quarter 2019

    Swedish Orphan Biovitrum AB (publ)  (Sobi™) today announces its results for the first quarter 2019. Total revenues were SEK 3,265 M (1,964), with 66 per cent revenue growth in the quarter compared with Q1 2018 (54 per cent at constant exchange rates (CER)). EBITA1 increased by 96 per cent to SEK 1,509 M (771) and adjusted EBITA2 was SEK 1,471 M, an increase of 91 per cent. Highlights · Total revenues of SEK 3,265 M (1,964). 66 per cent revenue growth in the quarter compared with Q1 2018 (54 per cent at constant exchange rates (CER)) · EBITA1increased by 96

    Sobi™ publishes 2018 Annual and Sustainability Report

    Swedish Orphan Biovitrum AB (publ)  (Sobi™) has released the company’s 2018 Annual and Sustainability Report. The integrated report summarises our business and strategy, financial performance and work on sustainability. “2018 was a year of transformation for Sobi,” says Guido Oelkers, CEO and President. “Our substantial progress in Haemophilia, acquisitions in Immunology and sales growth in Specialty Care mean that the company is essentially, on a pro-forma basis, two-and-a-half times the size it was at the end of 2016. But it is important to understand that we see

    Sobi publishes the report for the fourth quarter and full-year 2018

    Swedish Orphan Biovitrum AB (publ)  (Sobi™) today announces the results for the fourth quarter and full-year 2018. Total revenues grew 37 per cent compared with Q4 2017 (29 per cent at constant exchange rates (CER)) and amounted to SEK 2,571 M. EBITA was SEK 916 M, an increase of 48 per cent for the quarter, and gross margin amounted to 74 per cent.  Highlights · Total revenues of SEK 2,571 M (1,875) in Q4 and SEK 9,139 M (6,511) for the full year · 37 per cent sales growth in Q4 compared with Q4 2017 (29 per cent at (CER)) · EBITA1increased 48 per cent

    Sobi presents comprehensive study data on extended half-life haemophilia treatments at EAHAD

    Sobi™  will present data at the European Association of Haemophilia and Allied Disorders (EAHAD) conference in Prague, Czech Republic, 6-8 February 2019, showing evidence on the safety, efficacy and long-term benefits of its extended half-life products for the treatment of haemophilia. The studies that will be presented support Sobi’s commitment to develop a treatment paradigm that expand the possibilities and transform life for people with haemophilia. Sobi and our collaboration partner Sanofi will provide interim data on the incidence of inhibitors in previously

    At ASH, extended half-life therapies Elocta® and Alprolix® demonstrate proven efficacy and well-characterised safety over four years

    ASPIRE and B-YOND extension studies show no inhibitor development and consistently low annualised bleeding rates in study participants over four years with Elocta and Alprolix, respectively. Swedish Orphan Biovitrum AB (publ)  (Sobi™) and Bioverativ Inc ., a Sanofi-company, today announced the final results of ASPIRE and B-YOND, the most comprehensive long-term studies of extended half-life factor therapies in haemophilia. The data from both studies confirm the established safety and sustained efficacy of Elocta® (

    Sobi™ publishes the report for the third quarter 2018

    Swedish Orphan Biovitrum AB (publ)  (Sobi™) today announces the results for the third quarter 2018. Total revenues grew 45 per cent compared with Q3 2017 (34 per cent at constant exchange rates (CER)) and amounted to SEK 2,315 M. EBITA was SEK 933 M, an increase of 74 per cent for the quarter, and gross margin amounted to 75 per cent. Continued strong growth in Q3 · Total revenues of SEK 2,315 M (1,601) in Q3 and SEK 6,568 M (4,636) YTD(1) · 45 per cent sales growth in the quarter compared with Q3 2017 (34 per cent at CER) · EBITA increased 74 per cent to

    Sobi™ publishes the report for the second quarter 2018

    Swedish Orphan Biovitrum AB (publ)  (Sobi™) today announces the results for the second quarter 2018. Total revenues grew 40 per cent compared with Q2 2017 (36 per cent at constant exchange rates, CER) and amounted to SEK 2,289 M. EBITA was SEK 951 M, an increase of 94 per cent for the quarter, and gross margin amounted to 73 per cent. Q2 outperforms our expectations · Total revenues of SEK 2,289 M (1,639) for Q2 and SEK 4,253 M (3,035) for H1 · 40 per cent sales growth in the quarter compared with Q2 2017 (36 per cent at CER) · EBITA increased by 94 per

    Sobi emphasises commitment to haemophilia community at WFH 2018 World Congress

    Recent data show quality-of-life improvements for patients treated prophylactically with Elocta® and Alprolix®, extended half-life haemophilia therapies. Swedish Orphan Biovitrum AB (publ)  (Sobi™)(STO:SOBI) will present data at the World Federation of Hemophilia (WFH) 2018 World Congress, in Glasgow, Scotland, 20-24 May, demonstrating the company’s ongoing commitment to transforming the standard of care for people with haemophilia. Sobi will present real-world data demonstrating improvements in quality-of-life measures, including physical activity and joint pain,

    The Republic of Ireland switches all people with haemophilia A & B treated with replacement clotting factors to Sobi’s™ extended half-life therapies

    The Republic of Ireland has become the first country in Europe where every person with haemophilia will have access to the newest generation of haemophilia treatments, extended half-life therapies, under new supply contracts signed between the HSE (Health Services Executive) and Sobi™.  A new contract for the supply of Elocta® (efmoroctocog alfa), for the treatment of haemophilia A was signed in January 2018. It follows an earlier contract for the supply of Alprolix® (eftrenonacog alfa), for the treatment of haemophilia B. Both Elocta and Alprolix are extended half-

    New data show extended prophylactic dosing with Alprolix® provides safe and effective protection in people with severe haemophilia B

    Post-hoc longitudinal analysis from B-LONG and B-YOND studies shows patients who progressed to individualised prophylactic dosing intervals of 14 days or longer maintained low annualised bleeding rates.Swedish Orphan Biovitrum AB (publ)  (Sobi™)(STO:SOBI) and Bioverativ Inc.  (NASDAQ: BIVVV) today announce the results of a new post-hoc longitudinal analysis demonstrating that individualised dosing with extended half-life therapy, Alprolix® (eftrenonacog alfa), every 14 or more days may be a potential option for people with severe

    Invitation – Presentation of Sobi’s Q3 2017 results

    On 25 October, at 08:00 CET, Swedish Orphan Biovitrum AB (publ)  (Sobi™) will publish its report for the third quarter 2017. Financial analysts and media are invited to participate in a telephone conference, which will include a presentation of the results, on the same day at 14:00 CET. The event will be hosted by Sobi’s CEO and President, Guido Oelkers, and the presentation will be held in English. The presentation can be followed live, or afterwards on www.sobi.com. Slides used in the presentation will be made available on Sobi’s website prior to the telephone

    Sobi and Bioverativ highlight commitment to improving care for people with haemophilia at ISTH 2017 congress

    New data on joint health, immune tolerance induction, and long-term quality-of-life outcomes underscore the companies’ dedication to addressing unmet needs in haemophilia treatment and care.Swedish Orphan Biovitrum AB  (publ) (Sobi™) (STO: SOBI)  and Bioverativ Inc.  (NASDAQ: BIVV) today announces that new data from their extended half-life therapies, Alprolix® (eftrenonacog alfa)([Coagulation Factor IX (Recombinant), Fc Fusion Protein] and Elocta® (efmoroctocog alfa), marketed as ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion

    Sobi publishes 2016 Annual Report

    Swedish Orphan Biovitrum AB (publ)  (Sobi™) publishes today its 2016 Annual Report. The report summarises the business as well as financial highlights for 2016, and gives a deeper insight into the company’s strategic agenda and its patient-centric innovation model. “We took a major step in 2016 by launching Elocta and Alprolix, two first in class extended half-life Fc fusion clotting factors to people with haemophilia in Europe and in parts of the Middle East. Throughout the year we have come to understand the positive impact that these therapies can bring to

    Sobi™ receives approval from the European Medicines Agency for higher capacity drug substance manufacturing for Elocta®

    Swedish Orphan Biovitrum AB  (publ) (Sobi™) (STO:SOBI) has received approval from the European Medicines Agency (EMA) for the grouped type II 15 K Variation for Elocta® (efmoroctocog alfa). The variation involves several changes, including the approval of Elocta drug substance manufacturing in 15 000 litre scale bioreactors.  Elocta is a recombinant extended half-life factor VIII

    Sobi and Bioverativ to reveal new long-term safety and efficacy data of Elocta® and Alprolix® at EAHAD

    Swedish Orphan Biovitrum AB (publ)  (Sobi™) and Bioverativ Inc.  (NASDAQ: BIVVV) will present new haemophilia data at the 10th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD), taking place in Paris, France, 1-3 February 2017. Nine abstracts from Sobi- and Bioverativ[1] -led studies have been accepted for presentation during EAHAD, reflecting the companies’ commitment to the haemophilia community. The nine posters include data on the long-term safety and efficacy

    First patients enrolled in 24 month real-world study evaluating effectiveness of Elocta®

    Swedish Orphan Biovitrum AB (publ)  (Sobi™) today announces that the first patients have been enrolled in the A-SURE study (NCT02976753).  A-SURE is a 24-month real-world study evaluating the effectiveness of Elocta® compared to conventional FVIII products in the prophylactic treatment of patients with haemophilia A in Europe.  The efficacy and safety of Elocta have been established in clinical trials and the A-SURE study will provide data from a real-world setting, which can be made available to physicians, payers and reimbursement authorities in evaluating the

    Data reinforcing the long-term safety and efficacy of extended half-life haemophilia therapies Elocta® and Alprolix® highlighted at 58th ASH meeting

    New longitudinal data shows long-term prophylactic use of Elocta/Eloctate resulted in effective target joint resolution and improved quality of life measuresBiogen  (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (publ)  (Sobi™) (STO: SOBI) will present new data, including updated longitudinal safety and efficacy findings from phase 3 and extension studies, on the companies’ extended half-life therapies, Elocta® (efmoroctocog alfa)( marketed as Eloctate® in the United States and certain other countries) for haemophilia A and Alprolix® (

    Elocta® obtains national reimbursement in Spain, now available in the five largest markets in the EU

    Swedish Orphan Biovitrum AB (publ) (Sobi™)  today announces that the company’s product Elocta® (efmoroctocog alfa), a recombinant human factor VIII Fc-fusion protein with an extended half-life for the treatment of haemophilia A, has received national reimbursement approval in Spain. Elocta is already available in the UK, France, Italy, Germany, Sweden, Denmark, Norway, Switzerland, the Netherlands, Slovenia and the Republic of Ireland. “This approval is an important reimbursement milestone for Elocta, representing the last of the five largest markets in the EU. Our

    Elocta® obtains reimbursement in UK, Italy and France, complemented by real-world data and extensive patient experience

    Patient access to Elocta is increasing, contributing to further evidence generation and real-world patient experience for extended half-life factor VIII therapy Swedish Orphan Biovitrum AB (publ) (Sobi™)  today announces that the company’s product Elocta® (efmoroctocog alfa), a recombinant human factor VIII Fc-fusion protein with an extended half-life for the treatment of haemophilia A, has been approved for  reimbursement in the UK, Italy and France. These countries join Germany, Sweden, Denmark, Norway, Switzerland, the Netherlands, Slovenia and the Republic of

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