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    Sobi successfully completes acquisition of Dova Pharmaceuticals

    Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) and Dova Pharmaceuticals, Inc. (Dova) (NASDAQ: DOVA) announced today the completion of the acquisition of Dova by Sobi. Following the completion of Sobi’s successful tender offer to purchase outstanding shares of Dova for USD 27.50 per share, net to the seller thereof in cash, without interest and subject to any applicable withholding taxes, plus one non-transferable Contingent Value Right (CVR) which entitles Dova shareholders to an additional USD 1.50 per share upon approval of Doptelet® for use in Chemotherapy-Induced

    Sobi to acquire Dova Pharmaceuticals creating a global growth platform in haematology

    Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) today announced a definitive agreement to acquire Dova Pharmaceuticals, Inc. (NASDAQ:DOVA) by means of a tender offer. The consideration consists of an upfront payment of USD 27.50 per share in cash and, one non-tradeable Contingent Value Right (CVR). The CVR entitles Dova shareholders to an additional USD 1.50 per share upon approval of Doptelet® for use in Chemotherapy-Induced Thrombocytopenia (CIT) by the US Food and Drug Administration (FDA). The upfront cash component of the offer represents a premium of 36 per cent based on Dova’s

    Sobi has entered into agreement to sell Priority Review Voucher

    Swedish Orphan Biovitrum AB (publ)  (Sobi™) (STO:SOBI) has entered into an agreement to sell a US Food and Drug Administration (FDA) Priority Review Voucher (PRV) to AstraZeneca for a total cash consideration of USD 95 M. A PRV entitles the holder to FDA priority review of a single New Drug Application or Biologics License Application, which reduces the target review time and may potentially lead to an expedited approval. The PRV was acquired as part of the acquisition of

    Sobi invites entries to first Sobi Scientific Innovation Awards

    Sobi™ has established the Sobi Scientific Innovation Awards, with a focus on the future of haemophilia care, to recognise innovation and scientific excellence in haemophilia research. Entries will be assessed by an Adjudication Committee of independent, international haemophilia experts, according to scientific credit and contribution to haemophilia, overall concept novelty, as well as the anticipated ability of the research to help liberate life for people with haemophilia. Armin Reininger, Head of Medical and Scientific Affairs at Sobi, says the aim is to focus on research that

    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

    People with haemophilia and female carriers in Sweden have higher risk of anxiety, depression and pain, based on treatment patterns

    People with haemophilia have an increased risk of acute and chronic pain, and long-term disability, associated with bleeds. Anxiety and depression are other factors negatively affecting their quality of life. These were among the results of the MIND study, which aims to identify patterns of prescribed pain, anti-depressive and anti-anxiety medication and management of pain, depression and anxiety in people with haemophilia in four Nordic countries. The results of the MIND study also show that people with haemophilia in Sweden have a substantially higher prescription of analgesics than

    Rare strength powers growth – Sobi Capital Markets Day 2019

    Swedish Orphan Biovitrum AB (publ)  (Sobi™) is hosting a Capital Markets Day at Karolinska Institutet Biomedicum in Solna, Sweden, today. Presentations from senior management and an external expert are showcasing how Sobi is well positioned to use its rare strength to expand business in Haemophilia and Immunology. In 2018, Sobi announced both the acquisition of emapalumab from Novimmune SA and the Synagis® US franchise from AstraZeneca. These acquisitions have transformed Sobi’s business and focus, establishing a strong position in Immunology and a substantial US

    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™ appoints Amy Pott as new Head of Sobi North America

    Swedish Orphan Biovitrum AB (publ)  (Sobi™) has appointed Amy Pott as the new Head of Sobi North America. She takes over effective today, replacing Rami Levin who is leaving Sobi. “Sobi North America is entering a new phase in line with Sobi’s growth strategy, with the workforce growing more than fourfold in just more than a year. The launch of Gamifant and the integration of Synagis are key to the the company’s future and I am delighted to welcome Amy to Sobi for her to take on this challenge, says Guido Oelkers, CEO.” Amy Pott was most recently Group Vice

    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™ launches Liberate Life™, a vision of living life beyond haemophilia, on World Haemophilia Day

    To mark World Haemophilia Day, Sobi™ is launching Liberate Life™, a vision of living life beyond haemophilia. In a series of long-term commitments, Sobi seeks to shape new standards, optimise treatment, build evidence, create sustainable access and provide community support in haemophilia care. As the first initiative in showcasing the Liberate Life vision, Sobi is reaching out to the broader haemophilia community across Europe through social media, encouraging and motivating people to expect more from life and reach for the many possibilities that advances in care have made possible. An

    Sobi and Novimmune selected as Honourees for 2019 National Organization for Rare Disorders (NORD) Rare Impact Award in Industry Innovation for Gamifant® (emapalumab)

    Sobi™ and Novimmune SA have both been selected as honourees by the National Organization for Rare Disorders (NORD) for the 2019 Rare Impact Awards. The companies were nominated in the category of Industry Innovation in recognition of the US Food and Drug Administration (FDA) approval in November 2018 of Gamifant® (emapalumab-lzsg) for the treatment of paediatric (newborn and older) and adult patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy. The Rare Impact Awards recognise

    New emapalumab data presented at Transplantation and Cellular Therapy (TCT) Meeting highlight post-transplant treatment outcomes in primary HLH

    Swedish Orphan Biovitrum AB (publ)  (Sobi™) (STO:SOBI) and Novimmune SA announced the presentation of late-breaking data from the phase 2/3 clinical study of emapalumab-lzsg in primary haemophagocytic lymphohistiocytosis (HLH) at the 2019 Transplantation and Cellular Therapy (TCT) Meetings, February 20-24 in Houston, Texas. The data examine the outcomes of primary HLH patients who were treated with emapalumab and proceeded to haematopoietic stem cell transplantation (HSCT).

    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

    Invitation – Presentation of Sobi’s Q4/FY 2018 results

    On 20 February, at 08:00 CET, Swedish Orphan Biovitrum AB (publ)  (Sobi™) will publish its report for the fourth quarter and full year 2018. 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

    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

    New number of shares and votes in Swedish Orphan Biovitrum AB (publ)

    New number of shares and votes in Swedish Orphan Biovitrum AB (publ) As per 31 January 2019, the total number of shares in Swedish Orphan Biovitrum AB (publ)  (Sobi™) amounts to 297,515,209 shares. All shares are common shares. The total number of votes is 297,515,209. The increase in the number of shares and votes results from an issue of 24,193,092 common shares. The common shares have been issued in connection with the acquisition from AstraZeneca of rights to Synagis® (palivizumab) in the US. As per 31 January 2019 the company holds 3,423,726 common shares. --

    Ravicti® now available for all ages in Europe following approval of the expanded paediatric indication

    Swedish Orphan Biovitrum AB (publ)  (Sobi™) announces that Ravicti®, a therapy option for the treatment of patients with urea cycle disorders (UCDs), has received approval from the European Commission on 18 December 2018 for the paediatric indication (birth to two months of age) following a positive CHMP opinion from the European Medicines Agency (EMA). The previous indication for Ravicti (glycerol phenylbutyrate) was restricted to children aged more than two months.  “This new expanded indication allows all patients access to treatment, which is particularly

    Sobi™ completes acquisition of Synagis® US rights from AstraZeneca and exercises authorisation to issue shares

    Swedish Orphan Biovitrum AB (publ)  (Sobi™) (STO:SOBI) announced today that it has completed the acquisition from AstraZeneca of rights to Synagis® (palivizumab) in the US as well as rights to participate in 50 per cent of the future earnings of the candidate drug MEDI8897 in the US, as announced on 13 November 2018. Synagis is a medicine for the prevention of serious lower respiratory tract infections (LRTI) caused by respiratory syncytial virus (RSV) in high-risk infants and is the only approved preventative medicine for the condition. MEDI8897 is a follow-on

    Data presented at ASH support emapalumab as an innovative, targeted therapeutic option for primary HLH

    Swedish Orphan Biovitrum AB (publ) (Sobi™)  and Novimmune SA  are presenting data from the pivotal phase 2/3 clinical study of emapalumab-lzsg in primary haemophagocytic lymphohistiocytosis (HLH) as part of the late-breaking abstract session at the 60th Annual Meeting of the American Society of Hematology (ASH), taking place 1-4 December 2018, in San Diego. “Primary HLH is an aggressive hyper-inflammatory syndrome that can quickly become fatal if not treated. This study demonstrated that emapalumab treatment induced rapid and sustained

    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® (

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