Biogen Idec and Sobi announce European Medicines Agency validates Elocta(TM) (rFVIIIFc) Marketing Authorisation Application for review


Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO:
SOBI) today announced that the European Medicines Agency (EMA) has validated the
Marketing Authorisation Application (MAA) of Elocta((TM)) (rFVIIIFc), a
recombinant factor VIII Fc fusion protein product candidate for the treatment of
haemophilia A. The validation of the MAA initiates the EMA's review process.

Elocta is the European trade name for rFVIIIFc, also known as Eloctate((TM))
[Antihemophilic Factor (Recombinant), Fc Fusion Protein] in the U.S., Canada,
and Australia, where it is approved for the treatment of hemophilia A. Eloctate
is the first recombinant clotting factor VIII therapy with prolonged circulation
to provide protection from bleeding episodes with the potential for an extended
interval between prophylactic injections.

"The validation of Elocta's application by the EMA is an important step toward
bringing this innovative treatment to people with haemophilia A in Europe," said
Douglas E. Williams, Ph.D., executive vice president of Research and Development
at Biogen Idec. "Elocta has the potential to protect against bleeding episodes
while helping to address the challenge of frequent injections."

The regulatory application included results from the pivotal, Phase 3 clinical
study, A-LONG that examined the efficacy, safety and pharmacokinetics of
rFVIIIFc in males 12 years of age and older with severe haemophilia A and from
the Phase 3 clinical study, Kids A-LONG that evaluated the efficacy and safety
of rFVIIIFc in children with haemophilia A under 12 years of age.

Biogen Idec and Sobi are collaborators in the development and commercialization
of Eloctate/Elocta for haemophilia A. Sobi has an opt-in right to take over
final development and commercialisation of Elocta for the Sobi territories
(Europe, North Africa, Russia and most Middle Eastern markets). Biogen Idec
leads development for Eloctate/Elocta, has manufacturing rights, and has
commercialisation rights in North America and all other regions in the world
excluding the Sobi territories.

"Sobi and Biogen Idec are committed to addressing significant medical needs in
the global haemophilia community," said Birgitte Volck, M.D., Ph.D., senior vice
president of Development and Chief Medical Officer of Sobi. "We're working
collaboratively to deliver innovative medicines that have the potential to
change the way haemophilia A is treated."

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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 bleeding
episodes that may cause pain, irreversible joint damage and life-threatening
hemorrhages. The World Federation of Hemophilia global survey conducted in 2012
estimates that approximately 142,000 people worldwide are identified as living
with haemophilia A.

About the A-LONG Clinical Study
The Phase 3 A-LONG clinical study was an open-label, multi-center study
involving 165 previously treated males 12 years of age and older with severe
haemophilia A. The study evaluated individualized and weekly prophylaxis to
reduce or prevent bleeding episodes, and on-demand dosing to treat bleeding
episodes. In the individualized arm, each study participant started on a twice-
weekly dosing regimen. Participants' pharmacokinetic parameters were used to
guide adjustments to dosing interval (every three to five days), and dose (25 to
65 IU/kg) to target a minimum factor VIII level of 1 to 3 IU/dL or higher as
needed to prevent and control breakthrough bleeding episodes. In the study, the
dose in the weekly prophylaxis arm was 65 IU/ kg/week.

About the Kids A-LONG Clinical Study
The Kids A-LONG study is the first clinical study to evaluate an investigational
haemophilia therapy with a prolonged half-life in children younger than 12 years
of age. The study was a global, open-label, multi-center Phase 3 study involving
71 boys with severe haemophilia A with at least 50 prior exposure days to factor
VIII therapies.

Participants in both the A-LONG and Kids A-LONG clinical trials were able to
enroll in ASPIRE, a long-term extension clinical study evaluating the safety and
efficacy of Eloctate. For more information about these studies, please visit
www.biogenidec.com.

About Elocta
Elocta is an investigational, recombinant clotting factor therapy developed for
haemophilia 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 Elocta 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
haemophilia.

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, hematologic conditions and autoimmune disorders.
Founded in 1978, Biogen Idec is the world's oldest independent biotechnology
company and patients worldwide benefit from its leading multiple sclerosis and
innovative haemophilia therapies. For product labeling, press releases and
additional information about the Company, please visit www.biogenidec.com.

About Sobi
Sobi is an international specialty healthcare company dedicated to rare
diseases. Sobi's 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. Sobi also markets 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

 Sobi

 Media Contact:                 Investor Relations contact:

 Oskar Bosson                   Jörgen Winroth

 +46 70 410 71 80               +1 347-224-0819, +1 212-579-0506, +46 8 697 2135

 oskar.bosson@sobi.com          jorgen.winroth@sobi.com



 Biogen Idec

 Media Contact:                 Investor Relations Contact:

 Lee-Ann Murphy                 Ben Strain

 +1-781-464-3260                +1-781-464-2442

 public.affairs@biogenidec.com  IR@biogenidec.com


[HUG#1867719]

Attachments

EMA validates Elocta MAA file.pdf