Biogen Idec, Swedish Orphan Biovitrum deal

The partners disclosed details of a 2006 hemophilia deal covering Biogen Idec's recombinant Factor VIII and Factor IX Fc fusion proteins, which are in Phase III testing for hemophilia A and hemophilia B, respectively. Swedish Orphan Biovitrum has the option to take over final regulatory approval, pre-launch and commercialization activities in its territory of Europe, Russia, Turkey and the Middle East for $10 million per program. Upon EU approval of each program, Swedish Orphan Biovitrum will be liable to reimburse Biogen Idec 50% of all manufacturing and development expenses incurred from Oct. 1, 2009, through the date on which Swedish Orphan Biovitrum is registered as the marketing authorization holder. Swedish Orphan Biovitrum will also have to reimburse 100% of certain development expenses incurred exclusively for the benefit of its territory. If Swedish Orphan Biovitrum does not exercise its option, Biogen Idec will obtain full worldwide rights and will pay Swedish Orphan Biovitrum royalties subject to undisclosed terms.

The partners amended the deal in February 2010 to give Biogen Idec full responsibility for all development and costs for the programs. Biogen Idec also gained commercialization rights outside of Swedish Orphan Biovitrum's territory. The partners said the cross-royalty rate for both companies has been reduced, and the rates will be further adjusted until Biogen Idec's costs are reimbursed. ...