For the treatment and prevention of bleeding in haemophilia B patients
CMC Biologics of Denmark and US-based Inspiration Biopharmaceuticals have signed a supply agreement for the manufacture of bulk IB1001, a treatment for individuals with haemophilia B.
Under the terms of the agreement, CMC Biologics will manufacture Inspiration's intravenous recombinant factor IX (rFIX) product for at least six years. CMC Biologics expects manufacturing to begin this autumn.
Further details of the agreement were not disclosed.
IB1001 is close to completing Phase III clinical testing in Europe, the US, Israel, and India. Pending the outcome and subsequent regulatory approvals, IB1001 is expected to be the second recombinant FIX product to come to the market for haemophilia B.
‘We have worked with CMC Biologics on the process development and manufacture of clinical product supply of bulk IB1001 over the past five years, and we have great confidence in their development and manufacturing capabilities,’ said Andrew Grethlein, executive vp and coo at Inspiration Biopharmaceuticals. ‘We look forward to our continued relationship with CMC Biologics as IB1001 moves toward commercial launch.’