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Biogen Idec, Inc. (Massachusetts) (BIIB), Swedish Orphan Biovitrum Hemophilia Drug Delayed As FDA Seeks More Info



11/12/2013 1:34:04 PM

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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 the Credit Suisse Global Healthcare Conference in Phoenix, stated that the US Food and Drug Administration (FDA) has requested additional information pertaining to process validation of certain steps in the manufacturing process for ELOCTATE. As a result, Biogen Idec expects a PDUFA extension for ELOCTATE and the company is now planning for a mid-2014 commercial launch in the US based on on-going discussions with the FDA. Sobi believes that this updated timeline for FDA approval is unlikely to impact planned European approval timelines.

About the Fc Fusion Technology Platform

ELOCTATE is a clotting factor under development using Biogen Idec's novel and proprietary monomeric Fc fusion technology, which makes use of a naturally occurring pathway that delays the breakdown of factor in the body and cycles it back into the bloodstream, resulting in a longer circulating half-life. Fc fusion technology is used in seven FDA-approved products for the treatment of chronic diseases including rheumatoid arthritis, psoriasis and platelet disorders. Biogen Idec is the first and only to apply this proprietary technology to haemophilia.

About Haemophilia A

Haemophilia A is a rare, inherited disorder in which the ability of a person's blood to clot is impaired. Haemophilia A occurs in about one in 5,000 male births annually and is caused by having substantially reduced or no factor VIII activity, which is needed for normal blood clotting. People with haemophilia A experience bleeding episodes that can cause pain, irreversible joint damage and life-threatening haemorrhage. Injections of factor VIII can restore the coagulation process, control bleeding, and prevent new bleeding episodes. The Medical and Scientific Advisory Council of the National Haemophilia Foundation recommends prophylaxis as the optimal therapy for people with severe haemophilia A. Currently, prophylaxis in haemophilia A typically requires injections three times per week or every other day to maintain a sufficient circulating level of clotting factor.

About the Biogen Idec and Sobi Collaboration

Biogen Idec and Swedish Orphan Biovitrum (Sobi) are partners in the development and commercialization of ELOCTATE in haemophilia A and ALPROLIX in haemophilia B. Biogen Idec leads development, has manufacturing rights, and has commercialization rights in North America and all other regions excluding the Sobi territory. Sobi has the right to opt in to assume final development and commercialization in Europe (including Russia), the Middle East and Northern Africa.

About Sobi

Sobi is an international specialty healthcare company dedicated to rare diseases. Our mission is to develop and deliver innovative therapies and services to improve the lives of patients. The product portfolio is primarily focused on inflammation and genetic diseases, with three late stage biological development projects within haemophilia and neonatology. We also market a portfolio of specialty and rare disease products for partner companies. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and 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 OMX Stockholm. More information is available at www.sobi.com.

About Biogen Idec

Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, haemophilia and autoimmune disorders. Founded in 1978, Biogen Idec is the world's oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies, and the company generates more than $5 billion in annual revenues. For product labelling, press releases and additional information about the company, please visit www.biogenidec.com.

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