Sobi's collaboration partner Biogen Idec files marketing authorisation application for Elocta(TM) (rFVIIIFc) in Europe


Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that Biogen Idec has
submitted a Marketing Authorisation Application (MAA) for Elocta (rFVIIIFc)  to
the European Medicines Agency (EMA). Sobi has an exclusive opt-in right to
assume final development and commercialisation of Elocta in Europe, Russia, the
Middle East and Northern Africa.

The MAA filing with the EMA triggers the formal opt-in right, giving Sobi
approximately two months to exercise its option.

Elocta is a long-acting recombinant factor VIIIFc fusion protein product
candidate for people with haemophilia A. Elocta is the approved European trade
name for rFVIIIFc, also known as Eloctate(TM) in the U.S., Canada, and
Australia, where it is approved for the treatment of hemophilia A.

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About Haemophilia A
Haemophilia A is a rare, chronic, genetic disorder in which the ability of a
person's blood to clot is impaired, due to missing or reduced levels of a
protein known as factor VIII. People with haemophilia A experience recurrent and
extended bleeding episodes that cause pain and irreversible joint damage. Some
of these bleeding episodes can be life-threatening. According to the World
Federation of Hemophilia, an estimated 142,000 people worldwide are identified
living with haemophilia A.[1] Prophylactic injections of factor VIII can
temporarily replace the clotting factor necessary to control bleeding and
prevent new bleeding episodes.

About the Biogen Idec and Sobi Collaboration
Biogen Idec and Swedish Orphan Biovitrum (Sobi) are collaborators in the
development and commercialisation of Elocta/Eloctate for haemophilia A. Biogen
Idec leads development, has manufacturing rights, and has commercialisation
rights in North America and all other regions in the world excluding the Sobi
territory. Sobi has the right to opt in to assume final development and
commercialisation 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 two late stage biological
development projects within Haemophilia. 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 2013, Sobi had total revenues of SEK 2.2 billion
(€253 M) and about 550 employees. The share (STO: SOBI) is listed on NASDAQ OMX
Stockholm. More information is available at www.sobi.com.



For more information please contact:

Media relations                            Investor relations
Oskar Bosson                              Jörgen Winroth
Head of Communications            Vice President, Head of Investor Relations
T: +46 70 410 71 80                    T: +1 347-224-0819, +1 212-579-0506
oskar.bosson@sobi.com             jorgen.winroth@sobi.com


The above information was released for public distribution on 9 October 2014, at
21:00 CET.

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[1] World Federation of Hemophilia. Annual Global Survey 2012.
http://www1.wfh.org/publications/files/pdf-1574.pdf. Accessed January 28, 2014.




[HUG#1861970]

Attachments

032e_Elocta filing.pdf