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Sobi™ signs manufacturing agreements with Pfizer

Sobi™ signs manufacturing agreements with Pfizer

Press Releases   •   Apr 29, 2016 06:05 GMT

Sobi has extended the existing manufacturing agreement with Pfizer for the drug substance for ReFacto AF®/XYNTHA® until December 31, 2023. In addition, Sobi has decided to move production of Kineret® drug substance to Pfizer’s manufacturing site in Strängnäs, Sweden.

Sobi™ publishes its report for the first quarter 2016

Sobi™ publishes its report for the first quarter 2016

Press Releases   •   Apr 27, 2016 06:00 GMT

Sobi™ today announced its results for the first quarter 2016. Revenue for the quarter totalled SEK 1,273 M (865), an increase of 47 per cent compared to previous year. All parts of the business contributed to the result with Orfadin® and Kineret® delivering strong performance.

Sobi publishes 2015 Annual Report

Sobi publishes 2015 Annual Report

Press Releases   •   Apr 27, 2016 05:45 GMT

Sobi today published its 2015 Annual Report, themed “A new chapter of our story”. The integrated report summarises the business as well as financial highlights for 2015, and gives a deeper insight into the company’s strategic agenda and its patient-centric innovation model.

Bo Jesper Hansen to step down as Chairman of Sobi™ – Håkan Björklund to be nominated as new Chairman of the Board

Bo Jesper Hansen to step down as Chairman of Sobi™ – Håkan Björklund to be nominated as new Chairman of the Board

Press Releases   •   Feb 26, 2016 07:15 GMT

Sobi Chairman of the Board, Bo Jesper Hansen, MD, PhD, has informed the Sobi’s nomination committee that he will not stand for re-election at the 2016 annual general meeting of shareholders (AGM). The Nomination Committee will propose that the shareholders elect Håkan Björklund, PhD, as the new Chairman of the Board for Sobi.

Sobi™ publishes its report for the fourth quarter and full year 2015

Sobi™ publishes its report for the fourth quarter and full year 2015

Press Releases   •   Feb 26, 2016 07:10 GMT

Sobi today announced its results for the fourth quarter and full year 2015. Revenues for the full year totalled SEK 3,228 M (2,607), an increase of 24 per cent compared to previous year. Revenues for the fourth quarter were 15 per cent higher year-on-year and the product revenues grew 21 per cent, with Orfadin® (nitisinone) and Kineret® (anakinra) delivering strong performance.

Sobi announces commercial launch of Elocta® in first countries in Europe

Sobi announces commercial launch of Elocta® in first countries in Europe

Press Releases   •   Jan 11, 2016 07:00 GMT

Sobi today announced the commercial launch of Elocta® (efmoroctocog alfa) in first countries in Europe. Elocta is a recombinant human factor VIII Fc fusion protein with an extended half-life, and is the first haemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days.

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Sobi gains commercial rights for Relistor®, Deflux® and Solesta® from PharmaSwiss

Press Releases   •   Jan 07, 2016 07:00 GMT

Sobi today announced that the company has gained commercial rights from the Swiss based company PharmaSwiss SA, to distribute Relistor®, Deflux® and Solesta® in a territory including Western Europe, Czech Republic, Slovakia, Hungary and also for Relistor in Russia.

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Sobi and Biogen’s Elocta® (rFVIIIFc) approved in Europe for the treatment of haemophilia A

Press Releases   •   Nov 24, 2015 07:47 GMT

Sobi and Biogen today announced that the European Commission (EC) has approved Elocta® (rFVIIIFc) for the treatment of haemophilia A in all 28 European Union (EU) member states, as well as Iceland, Liechtenstein and Norway. Elocta will be the first haemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days.

Haemophilia therapy from largest multi-year donation now available to patients in developing world

Haemophilia therapy from largest multi-year donation now available to patients in developing world

Press Releases   •   Oct 12, 2015 11:37 GMT

World Federation of Hemophilia announces expansion of humanitarian aid programme. Biogen, Sobi and the World Federation of Hemophilia collaboration to enable a sustained humanitarian supply of haemophilia treatment with the potential to change treatment paradigm in developing countries.

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Kineret® receives Australian regulatory approval for use in Systemic Juvenile Idiopathic Arthritis

Press Releases   •   Aug 19, 2015 08:33 GMT

Sobi together with its Australian partner, A. Menarini Australia Pty Ltd received marketing authorisation in Australia for Kineret (anakinra) for the treatment of systemic juvenile idiopathic arthritis (SJIA), which is a rare form of juvenile chronic arthritis.

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Extension study data supporting long-term safety and efficacy of Eloctate®/Elocta® published in Haemophilia

Press Releases   •   Aug 10, 2015 11:06 GMT

Newly published clinical data demonstrate that people on extended-interval prophylaxis regimens with Eloctate®/Elocta® (rFVIIIFc) experienced low bleeding rates. Interim results show participants maintained low bleeding rates with prophylactic dosing.

Sobi publishes its Report for the Second Quarter 2015 – raises guidance

Sobi publishes its Report for the Second Quarter 2015 – raises guidance

Press Releases   •   Jul 16, 2015 06:12 GMT

Sobi today announced its results for the second quarter 2015. Revenues for the quarter totalled SEK 764 M (663), an increase of 15 percent year-on year. The product portfolio grew 25 per cent with Orfadin® and Kineret® delivering strong performance.

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Sobi exercises opt-in right for Alprolix®

Press Releases   •   Jul 16, 2015 06:02 GMT

Sobi announced today that the company has decided to exercise its opt-in right to take over final development and commercialisation of Alprolix (rFIXFc) for the territory composed of Europe, North Africa, Russia and certain Middle Eastern markets. Alprolix is a recombinant factor IX Fc fusion protein product candidate for the treatment of haemophilia B.

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European Commission approves Orfadin® oral suspension

Press Releases   •   Jun 29, 2015 06:05 GMT

The European Commission has approved the oral suspension formulation of Orfadin® (nitisinone) for the treatment of Hereditary Tyrosinaemia type-1 (HT-1) as of 19 June 2015. “The new oral suspension formulation is a demonstration of Sobi’s commitment to the needs of the infants and children diagnosed with HT-1 early in life,” says Birgitte Volck, Chief Medical Officer of Sobi.

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Biogen and Sobi announce European Medicines Agency validates Alprolix® (rFIXFc) marketing authorisation application

Press Releases   •   Jun 26, 2015 13:48 GMT

Biogen and Sobi today announced that the European Medicines Agency has accepted the companies’ Marketing Authorisation Application of Alprolix® (rFIXFc), a recombinant factor IX Fc fusion protein product candidate for the treatment of haemophilia B. This validation signifies the initiation of the EMA’s review process.

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New haemophilia data at ISTH congress to highlight extension study outcomes and paediatric use

Press Releases   •   Jun 18, 2015 10:00 GMT

Sobi and Biogen will present 23 company-sponsored platform and poster presentations at the ISTH 2015 congress taking place in Toronto, Canada, 20-25 June 2015. - Full results from Kids B-LONG Alprolix® paediatric study to be released for the first time - - Interim findings from ASPIRE, an open label extension study with Eloctate®/Elocta® in adults and children with haemophilia A -

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Sobi Board of Directors terminates discussions regarding non-binding proposal

Press Releases   •   Jun 08, 2015 06:00 GMT

​On 27 April 2015 the Board of Swedish Orphan Biovitrum AB (publ) (Sobi) confirmed that it had received a preliminary and conditional non-binding proposal in relation to a possible offer for all shares issued by the company. The Board of Directors of Sobi has terminated discussions regarding this proposal.

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Sobi’s partner Biogen submits marketing authorisation application for Alprolix® (rFIXFc) in Europe

Press Releases   •   Jun 04, 2015 06:00 GMT

Sobi announced today that partner Biogen has submitted a Marketing Authorisation Application (MAA) for Alprolix (rFIXFc) to the European Medicines Agency (EMA).

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Notice of annual general meeting in Swedish Orphan Biovitrum AB (publ)

Press Releases   •   May 27, 2015 06:00 GMT

The shareholders in Swedish Orphan Biovitrum AB (publ), Reg. No. 556038-9321, are hereby summoned to the annual general meeting (the “Meeting”), to be held on Tuesday 30 June 2015 at 2.00 p.m. in Wallenbergsalen at Kungliga Ingenjörsvetenskapsakademien (IVA), Grev Turegatan 16, Stockholm, Sweden.

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Sobi publishes its Report for the First Quarter 2015

Press Releases   •   May 06, 2015 06:00 GMT

Sobi today announced its results for the first quarter 2015. Revenues for the quarter totalled SEK 865 M (573). All parts of the business contributed to the result with ReFacto®, Orfadin® and Kineret® delivering strong performance.