Date: 2015-07-16
Type of information: Exercise of an option agreement
Compound: long-lasting rFVIIIFc (Elocta®) and rFIXFc (Alprolix™ - eftrenonacog alfa) hemophilia programs
Company: Swedish Orphan Biovitrum (Sobi) (Sweden) BiogenIdec (USA - MA)
Therapeutic area: Hematological diseases - Genetic diseases - Rare diseases
Type agreement: development
commercialisation
Action mechanism: fusion protein/protein/coagulation factor. Alprolix® is a recombinant factor IX Fc fusion protein product candidate for the treatment of haemophilia B. This clotting factor has been developed using Biogen Idec's novel and proprietary monomeric Fc fusion technology, which makes use of a natural pathway to recycle rFIXFc in circulation and enable it to remain in the body longer. With this technology, rFIXFc is designed to provide long-lasting protection from bleeding and reduce the treatment burden associated with hemophilia B, which currently requires more than 100 injections annually for prophylaxis with commercially-available Factor IX products. Eloctate® (efmoroctocog alfa) is an investigational, recombinant clotting factor therapy developed for hemophilia A by fusing factor VIII to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body). It is believed that this enables Eloctate® to use a naturally occurring pathway to prolong the time therapy remains in the body. While Fc fusion has been used for more than 15 years, Biogen Idec is the only company to apply it to the treatment of hemophilia.
Disease: hemophilia A, hemophilia B
Details: * On July 16, 2015, Swedish Orphan Biovitrum (Sobi) announced that the company has decided to exercise its opt-in right to take over final development and commercialisation of Alprolix® (rFIXFc) for the territory composed of Europe, North Africa, Russia and certain Middle Eastern markets. Sobi will make a payment to Biogen of $ 10 million, which will be held in escrow pending the EU regulatory approval of Alprolix®. * On 26 June 2015, Sobi and Biogen announced that the European Medicines Agency (EMA) had validated the Marketing Authorisation Application (MAA) for Alprolix. The validation of the MAA initiated the EMA's review process. Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein] is approved for the treatment of haemophilia B in the U.S., Canada, Australia, and Japan. * On November 21, 2014, Swedish Orphan Biovitrum announced that the company has decided to exercise its opt-in right to take over final development and commercialisation of Elocta®(rFVIIIFc) for the territory composed of Europe, North Africa, Russia and most Middle Eastern markets.Sobi will make a payment to Biogen Idec of $ 10 million, which will be held in escrow pending the EU regulatory approval of Elocta. * On February 6, 2012, Sobi and Biogen Idec have agreed to disclose further details on their agreement regarding development and commercialization of long-lasting recombinant factor VIII and factor IX haemophilia programs, which was restructured in February 2010. Under the new agreement, Biogen Idec assumed full development responsibilities and costs, as well as manufacturing rights. In addition, the cross-royalty rates were reduced and commercial rights for certain territories were changed. Subject to the exercise of an option right, Sobi will have commercial rights in Europe, Russia, Turkey and certain countries in the Middle East (the Sobi territory). Biogen Idec has commercial rights for North America (the Biogen North American territory) and for rest of the world markets outside of Europe, Russia, Turkey and certain countries in the Middle East (the Biogen Direct territory).
Financial terms: Under the terms of the option right and following Biogen Idec's submission of a marketing authorization application to the European Medicines Agency (EMA) for each program, Sobi may opt to take over final regulatory approval, pre-launch and commercialization activities in the Sobi territory at a cost of $ 10.0 million per program.
Upon EMA regulatory approval of each program, Sobi will be liable to reimburse Biogen Idec 50% of the sum of all manufacturing and development expenses incurred by Biogen Idec from 1 October 2009 through the date on which Sobi is registered as the marketing authorization holder, as well as 100% of certain development expenses incurred exclusively for the benefit of the Sobi territory.
To effect Sobi's reimbursement to Biogen Idec for each program, the cross-royalty structure for direct sales in each company's respective territories will be adjusted until the consideration is paid in full. The mechanism for reimbursement is outlined in the table below.
To effect Sobi's reimbursement to Biogen Idec for each program, the cross-royalty structure for direct sales in each company's respective territories will be adjusted until the consideration is paid in full.
If the reimbursement of the opt-in consideration has not been achieved within six years of the first commercial sale of the respective programs, Biogen Idec has the right to require Sobi to pay any remaining balances within 90 days of the six year anniversary date of the first commercial sale.
Should Sobi not exercise its option right with respect to one or both programs or should Sobi terminate the agreement with respect to one or both programs, Biogen Idec will obtain full worldwide development and commercialization rights for such affected program and will be obligated to pay royalties to Sobi subject to separate terms defined under the restructured collaboration agreement. In addition, if EMA approval for any program is not granted within 18 months of the applicable EMA filing date, Sobi shall have the right to require that the first opt-in payment be refunded and revoke its option right for such program.
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