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    +46 8 697 20 00
  • Gerard Tobin

    Head of Investor Relations


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    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 receives approval from Health Canada for Orfadin® oral suspension for the treatment of HT-1

    Swedish Orphan Biovitrum AB (publ)  (Sobi™) has received approval from Health Canada for an oral suspension formulation of Orfadin® (nitisinone). Orfadin is a medicine approved in multiple countries across North America and Europe for use in combination with dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinaemia type 1 (HT-1), a rare genetic disorder that can cause liver, renal and neurological complications and in most cases is fatal if untreated. “The introduction of new nitisinone dosing options, such as Orfadin oral

    Sobi receives approval from the FDA for once-daily dosing frequency of Orfadin® for the treatment of HT-1

    Swedish Orphan Biovitrum AB (publ)  (Sobi™) has received approval from the U.S. Food and Drug Administration (FDA) for a reduced dosing frequency for Orfadin® (nitisinone) from twice daily to once daily in patients 5 years of age and older. The approval is based on the results of a clinical study in 16 people with hereditary tyrosinaemia type 1 (HT-1), comparing a four week once-daily and four week twice daily dosing regimen. Orfadin is approved in combination with dietary restriction of tyrosine and phenylalanine for people with HT-1, a rare genetic disorder that

    Sobi obtains approval from the European Commission for new dosing frequency of Orfadin®

    Swedish Orphan Biovitrum International AB (publ)  (Sobi™) has received confirmation by the European Commission (EC) approving a reduced dosing frequency for Orfadin® (nitisinone) from twice daily to once daily, in people with hereditary tyrosinemia type 1 (HT-1) with a body weight >20 kg. “Sobi has a long-term commitment to improve the lives for people affected by hereditary tyrosinemia type 1, and the above modified dosing regimen is a further step in this journey”, says Milan Zdravkovic, Senior Vice President, Chief Medical Officer, and Head of Research &

    Health Canada approves Orfadin® capsules for the treatment of hereditary tyrosinaemia type-1 (HT-1)

    Swedish Orphan Biovitrum AB (publ)  (Sobi™) today announces that Health Canada has approved Orfadin® (nitisinone) capsules for the treatment of hereditary tyrosinaemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. HT-1 is a progressive, rare genetic disease that may result in liver and kidney complications and in most cases fatal if untreated. In the most common form of the disease, symptoms arise within the first six months of the child's life. Orfadin capsules will now be available in Canada in a wide range of dosing options;

    Health Canada validates Orfadin® capsule filing

    Swedish Orphan Biovitrum AB (publ)  (Sobi) announced today that Health Canada has initiated review of the application for approval of Orfadin® (nitisinone) capsules for the treatment of hereditary tyrosinaemia type-1 (HT-1). HT-1 is a rare genetic disease that affects infants and children. It is progressive and may result in liver and kidney complications and can be fatal if untreated. “We are very pleased that the review process for Orfadin capsules in Canada has started. Canada and Quebec is home to 10 per cent of the world’s HT-1 population and has been a

    Orfadin® 20 mg capsule approved in the US

    Swedish Orphan Biovitrum AB (publ)  (Sobi) announced today that the Food and Drug Administration (FDA) has approved a higher strength 20 mg capsule of Orfadin® (nitisinone) for the treatment of Hereditary Tyrosinaemia type-1 (HT-1). HT-1 is a rare genetic disease that affects infants and children. It is progressive and may result in liver and kidney complications and can be fatal if untreated. Twenty years ago, before pharmacological treatment was available, fewer than one third of infants diagnosed with HT-1 before two months of age lived past their second birthday.

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