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Swedish Orphan Biovitrum AB (publ): Sobi to initiate clinical development programs in acute gout and Still's disease, and receives US patent on new formulation

Swedish Orphan Biovitrum AB (publ) (Sobi(TM)), today announced that it has
decided to initiate two clinical programs with Kineret® (anakinra) in North
America, with the aim of evaluating two new potential indications for Kineret
where a significant need for alternative treatment options exists: acute gout
and Still's disease.

An increasing body of evidence suggests the potential involvement of
interleukin-1 (IL-1) in a number of autoinflammatory diseases, including rare
systemic inflammatory diseases such as Still's disease (systemic juvenile
idiopathic arthritis and adult onset Still's disease), as well as more common
autoinflammatory diseases such as acute gout.

"We look forward to initiating clinical trials to evaluate potential
indications where patients need additional treatment options," says Kristina
Timdahl, Medical Head Therapeutic Area Inflammation at Sobi. "We believe that
there is a continued great potential for Kineret and are pleased to be able
to further expand our strategic life-cycle development activities for the
product in an effort to meet needs of the medical and patient communities."

The acute gout program will include a dose-finding phase 2 study, followed by
a planned phase 3 study designed to evaluate the efficacy and safety of
Kineret treatment in resolving the auto-inflammatory driven pain of acute
flares. The Still's disease study is a phase 3 study designed to evaluate the
efficacy and safety of Kineret in newly diagnosed adult and paediatric
patients. The two clinical trials are expected to be initiated at the
beginning of 2017 and take place primarily in North America. Both programs
were reviewed in meetings with the US Food and Drug Administration (FDA)
during 2015.

In addition, Sobi has been granted a US patent for a citrate-free formulation
of anakinra which will expire in 2032. A corresponding patent has recently
been allowed in Europe and may be granted in 2016. Sobi plans to work with
the FDA and the European Medicines Agency (EMA) to define a pathway to
integrate the new formulation to its manufacturing of Kineret in the future.


acute gout

Acute gout is an autoinflammatory disease and an intensely painful and
disabling inflammatory arthritis involving one or several joints. The goal of
therapy in acute gout is prompt and safe termination of pain and disability.
Gout is also a disease that is associated with multiple comorbidities, which
may limit the use of some conventional treatment regimens.

About Still's disease

Still's disease is an auto-inflammatory disease that affects both children and
adults, and is characterised by high spiking fevers, intermittent rash and
arthritis. Still's disease is also referred to as systemic juvenile
idiopathic arthritis or adult-onset Still's disease. For patients with
Still's disease, there remains a high unmet need for a short-acting treatment
option with a quick onset of efficacy and a well-established benefit:risk

About Kineret®

Kineret® (anakinra) is a recombinant protein drug that blocks the biological
activity of IL-1a and IL -1b by binding to interleukin-1 type 1 receptor
(IL-R 1), expressed in a variety of tissues and organs, and thereby blocking
the interleukin-1 (IL-1) signalling. IL-1 is a key mediator of inflammation
and a significant contributor to autoinflammatory diseases. Kineret has a
well-characterised safety profile, a quick onset of action and a short

About Sobi(TM)

Sobi(TM) 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 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

| 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 |
007e_Kineret expanded LCM


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


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