Sobi has been involved in the process development and manufacturing of recombinant protein drugs since the technology was first developed more than 30 years ago, then as part of KabiVitrum.
Strong heritage in recombinant protein drugs
- Biovitrum was formed through the merger of several units of Pharmacia (now Pfizer) and spun off to a consortium of investors led by Nordic Capital and MPM Capital Funds.
- Operations included a research unit focused on metabolic diseases, a process development unit for protein drugs and a plasma product operation.
- The Company sold its plasma operation to Octapharma as part of efforts to concentrate operations on protein-based and small molecular drugs.
- Biovitrum started to manufacture the active protein component for Wyeth’s (now Pfizer’s) ReFacto® and ReFacto/Xynta® drugs for treatment of hemophilia.
- Marketing of specialty pharmaceuticals (ReFacto, Mimpara and Kineret) was initiated in the Nordic region.
- The research and development portfolio was expanded through the acquisition of Arexis, a Swedish biotech company.
- A partnership was formed with Syntonix (subsequently Biogen Idec) to jointly develop a drug for hemophilia B.
- Biovitrum was listed on NASDAQ OMX Stockholm.
- An option was utilized to cooperate with Syntonix/Biogen Idec in the development of a factor VIIIFc for treatment of hemophilia A.
- Agreement with Amgen regarding the acquisition of the products Kepivance® and Stemgen® as well as a global license for Kineret®.
- The decision was taken to initiate final registration studies for the recombinant factor FIXFc.
- Positive data were received for the Kiobrina® phase II program.
- Investor AB acquired 21% of the shares in Biovitrum.
- Acquisition of Swedish Orphan International, a pioneer in orphan drugs, and the creation of the new company Swedish Orphan Biovitrum.
- Signing of a number of distribution agreements.
- Re-structuring of the agreement with Biogen Idec regarding the rFVIIIFc and rFIXFc hemophilia projects.
- Decision taken to advance both hemophilia projects as well as Kiobrina to phase III.
- First patient enrolled in phase III study with Kiobrina in July.
- Data from the rFVIIIFc hemophilia phase I/II study presented showing an approximately 1.7-fold increase in half-life compared with Advate®.
- Establishment of a US subsidiary.
- Extension of supply agreement with Pfizer for ReFacto/Xyntha until 2020.
- Agreement with Pfizer for the return of co-promotion rights for the Nordic region for a payment of USD 47.4 M.
- Initiation of global pediatric clinical trials of long-lasting Hemophilia A and B product candidates.
- Collaboration formed with Swedish biotech company Affibody within the IL-1 field.