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2015-08-18

Swedish Orphan Biovitrum AB (publ): Results from B-YOND study reinforce long-term clinical profile of Alprolix for the treatment of haemophilia B

Swedish Orphan BiovitrumAB (publ) (Sobi) (STO: SOBI) and its partner Biogen
released interim results from the B-YOND study presented at the 67thAnnual
Meeting for the National Hemophilia Foundation in Dallas, Texas. The results
support the long-term safety and efficacy of Alprolix(R) (rFIXFc) in people
with severe haemophilia B treated for up to two years. Participants in this
phase 3, open-label long-term study maintained low bleeding rates with one to
two week prophylaxis regimens. No inhibitors have been reported to-date.

"B-YOND represents the most extensive longterm clinical data set for a
long-acting replacement FIX product. These interim results support the
efficacy and safety profile of Alprolix in paediatric patients as well as in
adults and adolescents", says Birgitte Volck, Chief Medical Officer at Sobi.

B-YOND is an ongoing extension study for people with severe haemophilia B who
completed the phase 3 pivotal B-LONG or Kids B-LONG study. The study's
primary endpoint is inhibitor development. From the beginning of B-LONG or
Kids-B-LONG until the B-YOND interim data analysis, the cumulative median
time on Alprolix was 171.6 weeks for adults and adolescents (n=93), and 95.3
weeks for children under age 12 (n=23).

Alprolix (rFIXFc) is an investigational recombinant clotting factor IX therapy
designed to have prolonged circulation in the body. According to the interim
analysis, adults and adolescents treated prophylactically maintained
protection against bleeding episodes with injections every one to two weeks.
These participants had overall median annualised bleeding rates (ABR) of 2.28
for weekly prophylaxis (20-100 IU/kg of Alprolix every seven days), 2.25 for
individualised prophylaxis (100 IU/kg of Alprolix every 8 to 16 days, or
every other week) and 2.42 for modified prophylaxis (personalised dosing if
optimal prophylaxis could not otherwise be achieved). In contrast, people
receiving on-demand therapy, or treatment when a bleeding episode occurred,
had a median ABR of 11.27.

The median overall ABR was zero for children under age six who received weekly
prophylaxis (n=9). For children six to 12 years old, median overall ABRs were
2.65 (n=10), 2.37 (n=5) and 3.13 (n=1) in weekly, individualised and modified
prophylaxis regimens, respectively. In each age group, the median average
weekly dose for participants previously on prophylaxis was similar for
individuals in the weekly and individualised treatment arms.

"Study participants receiving prophylactic treatment continue to experience
low bleeding rates during this long-term study. The B-YOND study plays an
important role in helping us understand this therapy's long-term clinical
profile and therapeutic value," says Professor John Pasi, Professor of
Haemostasis and Thrombosis at Barts and the London, United Kingdom.

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About Haemophilia B

Approximately 28,500 people are diagnosed with haemophilia B worldwide,
according to World Hemophilia federation. Haemophilia B is caused by
substantially reduced or no factor IX activity, which is needed for normal
blood clotting. People with haemophilia B experience bleeding episodes that
cause pain, irreversible joint damage, and life-threatening haemorrhages.
Prophylactic injections of factor IX temporarily replace clotting factors
necessary to control bleeding and prevent new bleeding episodes.

About Alprolix (rFIXFc)

Alprolix (rFIXFc) is a long-acting recombinant factor IX Fc fusion protein
product candidate for people with haemophilia B. Alprolix [Coagulation Factor
IX (Recombinant), Fc Fusion Protein], is the first recombinant, clotting
factor therapy with prolonged circulation in the body for adults and children
with haemophilia B, approved in the United States, Canada, Australia and
Japan. Alprolix was submitted to the European Medicines Agency (EMA) for
regulatory approval in Europe in June 2015.

Alprolix was developed by fusing factor IX to the Fc portion of immunoglobulin
G subclass 1, or IgG1 (a protein commonly found in the body). This enables
Alprolix to use a naturally occurring pathway to prolong the time the therapy
remains in the body.

About B-YOND

B-YOND is an ongoing long-term study for people with severe haemophilia B who
completed the phase 3 pivotal B-LONG or Kids B-LONG studies. The study's
primary endpoint is inhibitor development. B-YOND enrolled 116 males,
including 93 participants (81 per cent) who completed B-LONG, and 23 children
(100 per cent) of those who completed Kids B-LONG. Secondary endpoints of the
B-YOND study include ABRs (including spontaneous joint bleeding rates) per
participant and treatment exposure days per participant. Additional outcomes
are incidence of adverse events and serious adverse events, and evaluation of
treatment of a bleeding episode (number of injections, dose per injection).

About Sobi and
Biogen collaboration

Sobi and Biogen are collaboration partners in the development and
commercialisation of Alprolix for haemophilia B. Sobi has recently exercised
its opt-in right to assume exclusive final development and commercialisation
rights of Alprolix in Europe, Russia, North Africa and certain countries in
the Middle East. Biogen has led development for Alprolix, has manufacturing
rights, and has commercialisation rights in North America and all other
regions in the world excluding Sobi territory.

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

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| 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 |
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029e_B-YOND interim results
http://hugin.info/134557/R/1946180/705968.pdf

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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#1946180

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