DESIGNATION OF recombinant human coagulation factor IX Fc fusion protein (rFIXFc) AS AN ORPHAN DRUG

I, Dr Anthony Gill, Delegate of the Secretary for the purposes of 16J of the Therapeutic Goods Regulations 1990 (“the Regulations”), acting under subregulation 16J(2) of the Regulations, designate recombinant human coagulation factor IX Fc fusion protein (rFIXFc) as an orphan drug on the 20 September 2012 for the treatment of the control and prevention of haemorrhagic episodes in patients with haemophilia B (congenital factor IX deficiency or Christmas disease), including the control and prevention of bleeding in surgical settings.

The dose form of recombinant human coagulation factor IX Fc fusion protein (rFIXFc) for this indication is a lyophilised powder for reconstitution IV injection.

The sponsor of recombinant human coagulation factor IX Fc fusion protein (rFIXFc) is Biogen Idec Australia Pty Ltd.

(signed by)

Dr Anthony Gill

Delegate of the Secretary

20 September 2012