Sobi files to expand Kineret(R) label to include CAPS

Sobi files to expand Kineret(R) label to include CAPS 
STOCKHOLM, SWEDEN -- (Marketwire) -- 11/19/12 --  Sobi (STO: SOBI)
has filed an application for an EU Marketing Authorization with the
European Medicines Agency (EMA) for Kineret(R) (anakinra) for the
indication
of cryopyrin associated periodic syndromes (CAPS). 
The filing is based on positive safety and efficacy outcome data from
a long-term treatment study in children and adults with neonatal-onset
multisystem inflammatory disease (NOMID), the most severe form of
CAPS. The EMA filing follows the filing for Kineret for NOMID with
the US Food and Drug Administration (FDA) in July 2012, which has
been granted priority review with
an expected approval date of 25
December 2012. 
"The filing of Kineret for CAPS and NOMID in the EU and the US
respectively are
important milestones on Sobi's journey to increase
our support for the pediatric
rheumatology field as well as for the
rare disease community as a whole," said
Dr. Geoffrey McDonough, CEO
of Sobi. "In reaching these goals, we aim to provide
an important
treatment option to benefit patients affected by IL-1-related
conditions." 
Commenting on Sobi's decision to file, Dr. Marco Gattorno of Gaslini
Children's
Hospital in Genova, Italy and Principal Investigator of
the Eurofever Registry
for Autoinflammatory Diseases, stated: "CAPS
is a life-long, severely debilitating disease where patients suffer
substantial pain and progressive reduction in their quality of life.
We need to find these patients early and to provide demonstrated safe
and effective treatment options to avoid disease progression leading
to organ damage. Each patient is different, and the addition
of new
treatment alternatives would lead to increased flexibility and
better
opportunities for optimal treatment for all patients." 
About CAPS 
Cryopyrin associated periodic syndromes (CAPS) consist of three rare,
autosomal
dominant autoinflammatory conditions of varying severity
and oftentimes overlapping symptoms.  At the milder end of the scale
(FCAS), it is characterized by life-long, cold-induced inflammatory
episodes of fever, rash
and malaise. When of intermediate severity
(Muckle Wells syndrome), it is typically associated with more intense
and enduring flares and morbidity, including progressive 
hearing loss
and kidney failure secondary to amyloidosis
(a condition where
amyloid proteins are abnormally deposited in organs and/or
tissues).
In the most severe form (NOMID/CINCA), it is associated with
increased
mortality and nearly continuous rash, fevers, chronic
aseptic meningitis, sensorineural involvement, craniofacial
abnormalities and bone lesions. The incidence of CAPS is estimated to
be 1:1,000,000 worldwide. 
CAPS is characterized by uncontrolled overproduction of IL-1 beta.
IL-1 induces a number of inflammatory responses such as fever, pain
sensitization, bone and
cartilage destruction and acute plasma
protein response. 
About Kineret (anakinra) Kineret is a recombinant protein drug
approved for the treatment of rheumatoid
arthritis (RA). Kineret
blocks the biological activity of IL-1 by binding to the
interleukin-1 type 1 receptor, expressed in a wide variety of tissues
and organs. IL-1 is a key mediator of inflammation and driver of
autoinflammatory
diseases in both adults and children. For more
information on Kineret see the
Summary of Product Characteristics. 
About Swedish Orphan Biovitrum (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 inflammation and genetic diseases,
with three late stage biological
development projects within
hemophilia and neonatology. We also market more than
40 products for
companies in the specialty and rare disease space. Sobi is a
pioneer
in biotechnology with world-class capabilities in protein
biochemistry
and biologics manufacturing. In 2011, Sobi had total
revenues of SEK 1.9 billion
(EUR 214 M) and about 500 employees. The
share (STO: SOBI) is listed on NASDAQ OMX Stockholm. More information
is available at www.sobi.com. 
Sobi Press Release on November 19, 2012 in pdf format: 
http://hugin.info/134557/R/1659038/537001.pdf 
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants
that: 
(i) the releases contained herein are protected by copyright and    
other applicable laws; and 
(ii) they are solely responsible for the content, accuracy and     
originality of the information contained therein. 
Source: Swedish Orphan Biovitrum AB (publ) via Thomson Reuters ONE 
[HUG#1659038] 
For further information, please contact:
Birgitte Volck
Senior Vice President Development, Chief Medical Officer
Tel: +46 8 697 20 94
 
 
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