Sobi's Partner Biogen Idec Expects Mid-2014 US Launch Of ELOCTATE(r)

STOCKHOLM, Sweden, Nov. 12, 2013 (GLOBE NEWSWIRE) --
Swedish Orphan Biovitrum AB's (publ) (Sobi) partner Biogen Idec today, at theCredit Suisse Global Healthcare Conference in Phoenix, stated that the US Foodand Drug Administration (FDA) has requested additional information pertaining toprocess validation of certain steps in the manufacturing process for ELOCTATE. As a result, Biogen Idec expects a PDUFA extension for ELOCTATE and the companyis now planning for a mid-2014 commercial launch in the US based on on-goingdiscussions with the FDA. Sobi believes that this updated timeline for FDAapproval is unlikely to impact planned European approval timelines.- - -About the Fc Fusion Technology PlatformELOCTATE is a clotting factor under development using Biogen Idec's novel andproprietary monomeric Fc fusion technology, which makes use of a naturallyoccurring pathway that delays the breakdown of factor in the body and cycles itback into the bloodstream, resulting in a longer circulating half-life. Fcfusion technology is used in seven FDA-approved products for the treatment ofchronic diseases including rheumatoid arthritis, psoriasis and plateletdisorders. Biogen Idec is the first and only to apply this proprietarytechnology to haemophilia.About Haemophilia AHaemophilia A is a rare, inherited disorder in which the ability of a person'sblood to clot is impaired. Haemophilia A occurs in about one in 5,000 malebirths annually and is caused by having substantially reduced or no factor VIIIactivity, which is needed for normal blood clotting. People with haemophilia Aexperience bleeding episodes that can cause pain, irreversible joint damage andlife-threatening haemorrhage. Injections of factor VIII can restore thecoagulation process, control bleeding, and prevent new bleeding episodes. TheMedical and Scientific Advisory Council of the National Haemophilia Foundationrecommends prophylaxis as the optimal therapy for people with severe haemophiliaA. Currently, prophylaxis in haemophilia A typically requires injections threetimes per week or every other day to maintain a sufficient circulating level ofclotting factor.About the Biogen Idec and Sobi CollaborationBiogen Idec and Swedish Orphan Biovitrum (Sobi) are partners in the developmentand commercialization of ELOCTATE in haemophilia A and ALPROLIX in haemophiliaB. Biogen Idec leads development, has manufacturing rights, and hascommercialization rights in North America and all other regions excluding theSobi territory. Sobi has the right to opt in to assume final development andcommercialization in Europe (including Russia), the Middle East and NorthernAfrica.About SobiSobi is an international specialty healthcare company dedicated to rarediseases. Our mission is to develop and deliver innovative therapies andservices to improve the lives of patients. The product portfolio is primarilyfocused on inflammation and genetic diseases, with three late stage biologicaldevelopment projects within haemophilia and neonatology. We also market aportfolio of specialty and rare disease products for partner companies. Sobi isa pioneer in biotechnology with world-class capabilities in protein biochemistryand biologics manufacturing. In 2012, Sobi had total revenues of SEK 1.9 billion(€ 215 M) and about 500 employees. The share (STO: SOBI) is listed on NASDAQ OMXStockholm. More information is available at Biogen IdecThrough cutting-edge science and medicine, Biogen Idec discovers, develops anddelivers to patients worldwide innovative therapies for the treatment ofneurodegenerative diseases, haemophilia and autoimmune disorders. Founded in1978, Biogen Idec is the world's oldest independent biotechnology company.Patients worldwide benefit from its leading multiple sclerosis therapies, andthe company generates more than $5 billion in annual revenues. For productlabelling, press releases and additional information about the company, pleasevisit more information - not for publicationSobi: Media relations           Investor relations Oskar Bosson, Head of     Jörgen Winroth, Vice President, Head of Investor Communications            Relations T: +46 70 410 71 80       T: +1 347-224-0819, +1 212-579-0506, +46 8 697 2135 E:  E:                           Sobi's partner Biogen Idec expects mid-2014 US launch of ELOCTATE®:[HUG#1742595]