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2015-09-25

Swedish Orphan Biovitrum AB (publ): Biogen and Sobi receive positive opinion from CHMP for Elocta(TM) (rFVIIIFc) for the treatment of Haemophilia A

Biogen(NASDAQ: BIIB) andSwedish Orphan Biovitrum AB(publ) (Sobi) (STO: SOBI)
received a positive recommendation from the European Medicines Agency's
Committee for Medicinal Products for Human Use (CHMP) for the marketing
authorisation of Elocta(TM) (rFVIIIFc). Elocta is a recombinant factor VIII
Fc fusion protein product for the treatment of haemophilia A that, if
approved, would be the first haemophilia A treatment with prolonged
circulation available in the European Union (EU).

The positive opinion was based on results from the pivotal, phase 3 A-LONG
clinical study, which examined the efficacy, safety and pharmacokinetics of
rFVIIIFc in previously treated males 12 years of age and older with severe
haemophilia A, and from the phase 3 Kids A-LONG clinical study, which
evaluated the efficacy and safety of rFVIIIFc in previously treated male
children with haemophilia A under 12 years of age. The Committee's positive
opinion is now referred to the European Commission (EC), which grants
marketing authorisation for medicines in the EU.

"The CHMP's recommendation to approve Elocta is an important milestone in
potentially bringing this innovative therapeutic option to people with
haemophilia A across Europe," said Aoife Brennan, M.D, vice president of
Hematology, Clinical Development at Biogen. "The potential of Elocta to
provide protection against bleeding episodes with fewer prophylactic
infusions will, if approved, represent the first treatment advance in nearly
20 years for Europe's hemophilia community."

Elocta is the European trade name for rFVIIIFc, which is also known as
Eloctate® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] in the
U.S., Canada, Australia, New Zealand and Japan, where it is approved for the
treatment of haemophilia A. Commonly reported adverse drug reactions (>/= 1%
of subjects) in the clinical studies were arthralgia, malaise, myalgia,
headache and rash. Development of Factor VIII neutralising antibodies
(inhibitors) may occur following administration of Elocta.

Biogen and Sobi are collaboration partners in the development and
commercialisation of Elocta/Eloctate for haemophilia A. Last year, Sobi
exercised its opt-in right to assume final development and commercialisation
of Elocta in the Sobi territory (essentially, Europe, North Africa, Russia
and certain countries in the Middle East). Biogen leads development for
Elocta/Eloctate, has manufacturing rights, and has commercialisation rights
in North America and all other regions in the world excluding the Sobi
territory.

"We are committed to bringing meaningful treatment advances to the haemophilia
community in Europe and worldwide," said Birgitte Volck, M.D., Ph.D., senior
vice president of Development and chief medical officer of Sobi. "We welcome
the news of this positive CHMP opinion and look forward to the EC's
forthcoming Elocta decision."

- - -

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
haemorrhages. According to the World Federation of Hemophilia, an estimated
140,000 people worldwide are identified as living with haemophilia A.[1]

About the A-LONG clinical study

The phase 3 A-LONG clinical study was an open-label, multi-centre study
involving 165 previously treated males 12 years of age and older with severe
haemophilia A. The study evaluated individualised and weekly prophylaxis to
reduce or prevent bleeding episodes, and on-demand dosing to treat bleeding
episodes. In the individualised 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-centre 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
enrol in ASPIRE, a phase 3, open-label extension study evaluating the
long-term safety and efficacy of Eloctate. For more information about these
studies, please visitwww.biogen.com.

About Biogen

Through cutting-edge science and medicine, Biogen discovers, develops and
delivers to patients worldwide innovative therapies for the treatment of
neurodegenerative diseases, hematologic conditions and autoimmune disorders.
Founded in 1978, Biogen is one of the world's oldest independent
biotechnology companies and patients worldwide benefit from its leading
multiple sclerosis and innovative haemophilia therapies. For product
labelling, press releases and additional information about the company,
please visit www.biogen.com.

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 Haemophilia, Inflammation and Genetic diseases. We also market a
portfolio of specialty and rare disease products for partner companies across
Europe, the Middle East, North Africa and Russia. Sobi is a pioneer in
biotechnology with world-class capabilities in protein biochemistry and
biologics manufacturing. In 2014, Sobi had total revenues of SEK 2.6 billion
(USD 380 M) and about 600 employees. The share (STO: SOBI) is listed on
NASDAQ OMX Stockholm. More information is available atwww.sobi.com.

For more information please contact

----------------------------------------------------------------------------------------------------
| Sobi |
| Media relations Investor relations |
| Oskar Bosson, Head of Communications Jörgen Winroth, Vice President, Head of Investor Relations |
| T: +46 70 410 71 80 T: +1 347-224-0819, +1 212-579-0506, +46 8 697 2135 |
| oskar.bosson@sobi.com jorgen.winroth@sobi.com |
| |
| Biogen |
| Media relations Investor relations |
| Lee-Ann Murphy Ben Strain |
|+1-781-464-3260 1-781-464-2442 |
| public.affairs@biogen.com IR@biogen.com |
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---------------------------------------[1]World Federation of Hemophilia. Annual Global Survey
2012.http://www1.wfh.org/publications/files/pdf-1574.pdf. Accessed July 2015.

035e_Elocta CHMP rekommendation
http://hugin.info/134557/R/1954568/711335.pdf

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Swedish Orphan Biovitrum AB (publ) via Globenewswire

HUG#1954568

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