Alprolix® (rFIXFc) approved in the EU for the treatment of haemophilia B

First Fc Fusion therapy approved for haemophilia B in the EU to provide extended
protection against bleeds
Swedish Orphan Biovitrum AB (publ) (http://www.sobi.com/) (Sobi™) (STO: SOBI)
and Biogen (http://www.biogen.com) (NASDAQ: BIIB) today announced that the
European Commission (EC) has approved Alprolix® (rFIXFc), their extended half
-life therapy, for the treatment of haemophilia B in all 28 European Union (EU)
member states and maintained its orphan designation. Alprolix is the only
recombinant factor IX Fc Fusion protein therapy for haemophilia B to offer
people in the EU prolonged protection against bleeding episodes with fewer
prophylactic injections.

Alprolix is indicated for both on-demand and prophylaxis treatment of people
with haemophilia B in all ages. Prophylactically, it can be administered with an
initial dose every seven days or every 10 days with the ability to adjust the
dosing interval based on individual response.

“With the approval of Alprolix, people with haemophilia B in Europe now have the
potential to experience prolonged protection from bleeds with fewer injections,”
said Krassimir Mitchev, M.D., Ph.D., vice president and medical therapeutic area
head of Haemophilia at Sobi. “We are working to make Alprolix available in
Europe as quickly as possible. Along with Biogen, we’re excited to continue
offering innovative therapies to people with haemophilia around the world.”

The EC’s approval of Alprolix was based on results from two global phase 3
clinical trials that demonstrated the efficacy, safety and pharmacokinetics of
Alprolix for haemophilia B: the pivotal B-LONG study for previously treated
adults and adolescents, and the Kids B-LONG study for previously treated
children under age 12. The adverse drug reactions with an incidence of ≥ 0.5
percent for Alprolix were nasopharyngitis (common cold), influenza, arthralgia
(joint pain), upper respiratory tract infection, headache, and hypertension. The
majority of these events were judged as not related or likely not related to
study drug.

“Alprolix has become a meaningful treatment advance for people living with
haemophilia B in countries where it is approved and is backed by robust clinical
data and the longest real-world experience of any prolonged circulation factor
IX therapy to date.” said Gilmore O’Neill, M.D., senior vice president Drug
Innovation Units at Biogen. “We’re proud to bring the European haemophilia
community one of the first treatment advances in nearly 20 years, and believe
the availability of extended half-life therapies in Europe will change the way
that many approach treatment.”

Sobi and Biogen collaborate on the development and commercialisation of Alprolix
for haemophilia B. Sobi has final development and commercialisation rights in
the Sobi territory (essentially Europe, North Africa, Russia and most Middle
Eastern markets). Biogen leads development and manufacturing for Alprolix and
has commercialisation rights in North America and all other regions in the world
excluding the Sobi territory.

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About Alprolix®
Alprolix® is a recombinant clotting factor therapy developed for haemophilia B
by fusing factor IX to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a
protein commonly found in the body). This technology enables Alprolix to use a
naturally occurring pathway to prolong the time the therapy remains in the body.
While Fc fusion has been used for more than 15 years, Sobi and Biogen are the
first companies to utilise it in the treatment of haemophilia.

Alprolix is currently approved for the treatment of haemophilia B in the United
States, European Union, Canada, Japan, Australia, New Zealand, and other
countries, to provide prolonged protection from bleeds. As with any infused
protein, allergic type hypersensitivity reactions and development of inhibitors
may occur following administration of Alprolix.

About Haemophilia B
Haemophilia B is caused by having substantially reduced or no factor IX
activity, which is needed for normal blood
clotting.[1] (http://connect.ne.cision.com#_edn1) The World Federation of
Hemophilia estimates that approximately 28,000 people are currently diagnosed
with haemophilia B worldwide.[2] (http://connect.ne.cision.com#_edn2)

People with haemophilia B may experience bleeding episodes in joints and muscles
that cause pain, decreased mobility and irreversible joint damage. In the worst
cases, these bleeding episodes can cause organ bleeds and life-threatening
haemorrhages. Infusions of factor IX temporarily replace clotting factors
necessary to resolve bleeding and, when used prophylactically, to prevent new
bleeding episodes.1

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 Haemophilia, Inflammation and Genetic diseases. Sobi also markets a
portfolio of specialty and rare disease products across Europe, the Middle East,
North Africa and Russia for partner companies. Sobi is a pioneer in
biotechnology with world-class capabilities in protein biochemistry and
biologics manufacturing. In 2015, Sobi had total revenues of SEK 3.2 billion
(USD 385 M) and about 700 employees. The share (STO: SOBI) is listed on NASDAQ
OMX Stockholm. More information is available at www.sobi.com.

About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops and
delivers worldwide innovative therapies for people living with serious
neurological, autoimmune and rare diseases. 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 more information, please visit www.biogen.com and follow us on
Twitter.

Biogen Safe Harbor
This press release contains forward-looking statements, including statements
about the potential benefits of Alprolix® in haemophilia B, including any
changes in the treatment approach for patients with haemophilia B. These forward
-looking statements may be accompanied by such words as “anticipate,” “believe,”
“could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,”
“project,” “target,” “will” and other words and terms of similar meaning. You
should not place undue reliance on these statements. These statements involve
risks and uncertainties that could cause actual results to differ materially
from those reflected in such statements, including uncertainty of success in
commercialization of Alprolix, which may be impacted by, among other things,
slower than anticipated acceptance of Alprolix by patients and the medical
community, competition in the hemophilia market, the effectiveness of sales and
marketing efforts, dependence on third party collaborations and collaborators,
problems with the manufacturing process for Alprolix, the occurrence of adverse
safety events, difficulties in obtaining or changes in the availability of
reimbursement for our products, failure to obtain regulatory approvals in other
jurisdictions, failure to protect intellectual property and other proprietary
rights, product liability claims and the other risks and uncertainties that are
described in the Risk Factors section of our most recent annual or quarterly
report and in other reports we have filed with the U.S. Securities and Exchange
Commission (SEC). Any forward-looking statements speak only as of the date of
this press release and we assume no obligation to update any forward-looking
statements, whether as a result of new information, future events, or otherwise.

For more information please contact:

Sobi
Media relations              Investor relations
Oskar Bosson, Head of        Jörgen Winroth, Vice
Communications               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 contact                Investor relations
Todd Cooper                  Benjamin Strain
+1-781-464-3260              1-781-464-2442
public.affairs@biogen.com    IR@biogen.com

Benjamin Russell
+41 41 392 1702
publicaffairs.eu@biogen.com

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[1] (http://connect.ne.cision.com#_ednref1) World Federation of Hemophilia.
About Bleeding Disorders – Frequently Asked Questions. Available at:
http://www.wfh.org/en/page.aspx?pid=637#Difference_A_B. Accessed on: February
11, 2016.

[2] (http://connect.ne.cision.com#_ednref2) World Federation of Hemophilia.
Report on the Annual Global Survey 2013. Available at:
http://www1.wfh.org/publications/files/pdf-1591.pdf. Accessed on: February 11,
2016.