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[{"orgOrder":0,"company":"OxThera AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"OxThera Announces Completion of Recruitment in Phase 3 ePHex Study With Oxabact\u00ae in Patients With Primary Hyperoxaluria","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Large molecule","productStatus":"Undisclosed","date":"April 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"OxThera AB"},{"orgOrder":0,"company":"OxThera AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"OxThera reports Results from Phase 3 ePHex Study with Oxabact in Primary Hyperoxaluria Patients with Maintained Kidney Function","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"OxThera AB"},{"orgOrder":0,"company":"Swedish Orphan Biovitrum AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Data to be Presented at ISTH Virtual Congress Highlights Sobi's Commitment to Advancing Rare Haematology Treatments","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Swedish Orphan Biovitrum AB"},{"orgOrder":0,"company":"Swedish Orphan Biovitrum AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sobi's Orfadin\u00ae (nitisinone) Receives Positive Opinion from CHMP for Treatment of AKU","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Swedish Orphan Biovitrum AB"},{"orgOrder":0,"company":"Swedish Orphan Biovitrum AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Patient Dosed in Phase 3 XTEND-Kids Study with Efanesoctocog Alfa in Children with Haemophilia A","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Swedish Orphan Biovitrum AB"},{"orgOrder":0,"company":"Swedish Orphan Biovitrum AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Grants Priority Review to Efanesoctocog Alfa for People With Hemophilia A","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Swedish Orphan Biovitrum AB"},{"orgOrder":0,"company":"Swedish Orphan Biovitrum AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NEJM Publishes Data Demonstrating Clinically Meaningful Prevention of Bleeds and Superior Bleed Protection for Efanesoctocog Alfa","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Swedish Orphan Biovitrum AB"}]

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            Details:

            BIVV001 (efanesoctocog alfa) is a novel and investigational recombinant factor VIII therapy with the potential to deliver near-normal factor activity levels for most of the week, extending bleed protection in a once-weekly dose for people with haemophilia A.

            Lead Product(s): Efanesoctocog Alfa

            Therapeutic Area: Genetic Disease Product Name: BIVV001

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 26, 2023

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            Efanesoctocog alfa (BIVV001) delivers high sustained factor activity levels in the normal to nearnormal range for the majority of the week with once weekly prophylaxis dosing, providing higher protection for longer.

            Lead Product(s): Efanesoctocog Alfa

            Therapeutic Area: Genetic Disease Product Name: BIVV001

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 30, 2022

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            Oxabact is a bi-modal enteric biotherapy containing a lyophilized formulation of Oxalobacter formigenes, a non-pathogenic, oxalate-degrading commensal bacterium used for treatment of Primary Hyperoxaluria.

            Lead Product(s): Oxalobacter formigenes

            Therapeutic Area: Genetic Disease Product Name: Oxabact

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 11, 2021

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            XTEND-Kids is an open-label, non-randomised interventional, single-arm study. Participants will receive a weekly prophylactic dose of efanesoctocog alfa for 52 weeks.

            Lead Product(s): Efanesoctocog alfa

            Therapeutic Area: Genetic Disease Product Name: BIVV001

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 13, 2021

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            European Medicines Agency (EMA) has adopted a positive opinion for Orfadin® (nitisinone) for the treatment of adult patients with alkaptonuria (AKU). The opinion is based on the scientific results of the DevelopAKUre clinical development programme.

            Lead Product(s): Nitisinone

            Therapeutic Area: Genetic Disease Product Name: Orfadin

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 18, 2020

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            Data for Doptelet® (avatrombopag) in treatment for thrombocytopenia within Chronic Liver Disease (CLD) and Chronic Immune Thrombocytopenia (ITP) will be presented.

            Lead Product(s): rFVIIIFc-VWF-XTEN

            Therapeutic Area: Genetic Disease Product Name: BIVV001

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 08, 2020

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            Study OC5-DB-02 (ePHex) is a 12-month randomized, double-blind, placebo-controlled, global, multicenter Phase 3 study to evaluate the efficacy and safety of Oxabact OC5.

            Lead Product(s): Oxalobacter formigenes

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 06, 2020

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