Sobi’s Elocta® (rFVIIIFc) approved in Switzerland for the treatment of haemophilia A

Swedish Orphan Biovitrum AB (publ) (http://www.sobi.com) (Sobi™) (STO: SOBI)
today announced that the Swiss Agency for Therapeutic Products, Swissmedic, has
approved Elocta® (rFVIIIFc) for the treatment of haemophilia A. Elocta is the
only recombinant factor VIII Fc fusion protein with an extended half-life
approved for haemophilia A treatment in Switzerland to offer prolonged
protection against bleeding episodes with prophylactic injections every three to
five days.

“The Swiss approval of Elocta is an important milestone for the country’s
haemophilia A community, offering the potential to improve the care of people
with haemophilia A,” said Krassimir Mitchev, M.D., Ph.D., vice president and
medical therapeutic area head of Haemophilia at Sobi. “Our focus is now to
ensure timely and sustainable access to Elocta for people living with
haemophilia A in Switzerland.”

Elocta is indicated for both on-demand and prophylaxis treatment of people with
haemophilia A of all ages. The Swiss approval was based on data from Elocta’s
pivotal, phase 3 A-LONG clinical study, which demonstrated 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 demonstrated the efficacy and safety of rFVIIIFc in previously
treated male children with haemophilia A under 12 years of age.

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

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About Elocta®

Elocta® (efmoroctocog alfa) is the first recombinant clotting factor VIII
therapy in Switzerland that offers an extended half-life in the body. It is
indicated for the treatment and prophylaxis of bleeding episodes in patients
with haemophilia A (factor VIII deficiency) and can be used by people of all
ages. Elocta was developed by fusing B-domain deleted factor VIII to the Fc
portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the
body). This enables Elocta to utilise a naturally occurring pathway to prolong
the time the therapy remains in the body. While Fc fusion technology has been
used in other therapies for more than 15 years, Sobi and Biogen are the first
companies to utilise it in the treatment of haemophilia. As with any infused
protein, allergic type hypersensitivity reactions and development of inhibitors
may occur following administration of Elocta. For full prescribing information
visit www.swissmedicinfo.ch.

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] (http://#_ftn1)

Therapies for haemophilia A, the most common form of haemophilia, can be
administered either on a schedule to help prevent or reduce bleeding episodes
(prophylaxis) or to control bleeding when it occurs (on-demand). The World
Federation of Hemophilia recommends that prophylaxis be the goal of therapy
because it may prevent bleeding and joint destruction. As a result, regular
prophylactic treatment may slow progression of joint disease and may improve
quality of life.

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 primary
focused on Haemophilia, Inflammation and Genetic diseases. We also market a
portfolio of speciality 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 2015, Sobi had total revenues of SEK 3.2 billion
(USD 385 M) and approximately 700 employees. The share (STO:SOBI) is listed on
NASDAQ Stockholm.

For more information please contact

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

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[1] (http://#_ftnref1) World Federation of Hemophilia. Annual Global Survey
2012. http://www1.wfh.org/publications/files/pdf-1574.pdf. Accessed July 2015