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Sobi, Biogen Idec Revise Hemophilia Pact

Biogen assumes full development responsibilities and costs

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Sobi and Biogen Idec have updated their agreement regarding the development and commercialization of long-lasting recombinant factor VIII and factor IX hemophilia programs. Biogen has assumed full development responsibilities and costs, as well as manufacturing rights. Sobi will have commercial rights in Europe, Russia, Turkey and certain countries in the Middle East. Biogen has commercial rights for North America and for rest of the world markets.

Following Biogen’s submission of a marketing authorization application to the EMA for each program, Sobi may opt to take over final regulatory approval, pre-launch and commercialization activities in its territories for $10 million per program.

Upon approval of each program, Sobi will reimburse Biogen 50% of all manufacturing and development expenses incurred, as well as 100% of certain development expenses incurred exclusively for the benefit of the Sobi territory. Sobi is eligible for certain royalties on sales in each company’s respective territories. If Sobi does not exercise its option right for one or both programs, Biogen will obtain full worldwide development and commercialization rights and will be obligated to pay royalties to Sobi.

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