Swedish Orphan Biovitrum AB (publ) (Sobi) has entered into an expanded agreement with Sanofi to exercise early opt-in for the development and commercialisation of BIVV 001 for the treatment of hemophilia A.

Swedish Orphan Biovitrum AB (publ) (Sobi) has entered into an expanded agreement with Sanofi to exercise early opt-in for the development and commercialisation of BIVV 001, an investigational extended half-life factor VIII therapy with the potential to provide extended protection from bleeds with once-weekly dosing for people with haemophilia A.

Sobi will make a payment to Sanofi of $50 million and will become a development partner in this programme. Upon potential approval in the EU, Sobi will pay a royalty on revenues in Sobi�s territories and receive royalties on Sanofi revenues in its territories.

In 2014, Sobi elected to add the BIVV 001 development programme to the collaboration agreement . BIVV 001 (rFVIIIFc-VWF-XTEN) is the first investigational factor VIII therapy to break through the von Willebrand factor ceiling in haemophilia A and is designed to provide extended protection from bleeds with once-weekly prophylactic dosing.

Data from the BIVV 001 phase 1/IIa study was presented at the 27th congress of the International Society on Thrombosis and Haemostasis (ISTH), in July 2019, and underscored the potential for once-weekly dosing with sustained high factor levels in haemophilia A. BIVV 001 was granted orphan drug designation by the FDA in August 2017 and the European Commission in June 2019.

In the collaboration agreement with Sanofi, Sobi holds the commercial rights for joint haemophilia programmes for Europe, North Africa, certain countries in the Middle East, and Russia (Sobi�s territory). In connection with the expansion of the collaboration agreement, a new supply contract with Sanofi until 2027 regarding Elocta and Alprolix has been agreed, with the potential for expansion to include BIVV 001.

Upon EU regulatory approval of BIVV 001, Sobi will be liable to pay the balance of the development costs incurred for BIVV 001. The total payment obligation is currently estimated to reach approximately $ 280-290 million (including the $50 million payment). The royalty structure under the agreement states that Sobi will pay Sanofi 9 per cent of direct sales in the Sobi territory, and Sanofi will pay Sobi 8 per cent of direct sales in North America and 13 per cent of direct sales in other markets.