STOCKHOLM, SWEDEN--(Marketwire - August 26, 2010) - Swedish Orphan Biovitrum (STO: SOBI)
today
announced that the US FDA Office of Orphan Products Development (OOPD) has
granted orphan drug designation (ODD) to Kineret® for the treatment of
cryopyrin-associated periodic syndromes (CAPS).
CAPS is a rare autoinflammatory condition with very severe symptoms
and is
potentially lethal. CAPS is characterized by excessive production
of the
endogenous inflammatory protein interleukin 1B (IL-1B).
Kineret® is a
recombinant version of the naturally occurring IL-1 receptor antagonist
which
blocks the IL-1 receptor.
"The orphan drug designation (ODD) is an important step in our
efforts to
document Kineret for the severe and very debilitating disease CAPS. An ODD
gives
advantages in FDA assistance, user-fee benefits and, after orphan
drug
registration, seven years of market exclusivity. This will help us
in our
efforts to offer this potentially very valuable product to CAPS patients
with
high unmet medical needs." said Peter Edman, Ph.D., Chief Scientific
Officer of
Swedish Orphan Biovitrum.
About cryopyrin-associated periodic syndromes (CAPS)
Cryopyrin-associated periodic syndromes are members of a
family of
autoinflammatory diseases. CAPS is a rare, autosomal dominant disease
consisting
of three autoinflammatory conditions of varying severity and
oftentimes
overlapping symptoms. At the milder end it is characterized by life-
long,
cold-induced inflammatory episodes of fever, rash and malaise.
When of
intermediate severity, it is typically associated with more intense and
enduring
flares and morbidity including progressive hearing loss and kidney
failure
secondary to amyloidosis (a condition whereamyloid proteins are
abnormally
deposited in organs and/or tissues). In the most severe form
(NOMID/CINCA) is
associated with high mortality and nearly continuous fevers, rash,
chronic
aseptic meningitis, sensorineural involvement, craniofacial
abnormalities, and
exuberant bone lesions. The incidence is estimated to be
approximately
1:1,000,000 worldwide, but could be underestimated.
CAPS is characterized by excessive or uncontrolled IL-1B production. IL-1
induces a number of inflammatory responses such as fever, pain
sensitization,
bone and cartilage destruction and acute plasma protein response.
Approximately
20% of untreated children with NOMID/CINCA syndrome die before reaching
adulthood.
About Kineret® (anakinra)
In December 2008, Swedish Orphan Biovitrum obtained from Amgen the
global
exclusive rights to Kineret® for rheumatoid arthritis as currently
indicated in
its label. In November 2009, the agreement regarding Swedish Orphan
Biovitrum's
Kineret® license was expanded to include certain orphan indications.
Information
about Kineret® can be found at the following site:
http://www.kineretrx.com/
Healthcare professionals should refer to and rely upon the PDR (Physician's
Desk
Reference) or the corresponding national labeling texts.
About Swedish Orphan Biovitrum
Swedish Orphan Biovitrum is a Swedish based niche specialty
pharmaceutical
company with an international market presence. The company is
focused on
providing and developing specialist pharmaceuticals for rare disease
patients
with high medical needs. The portfolio consists of about 60 marketed
products
and an emerging late stage clinical development pipe-line. Our focus areas
are:
hemophilia, inflammation/autoimmune diseases, fat malabsorption,
cancer
supportive care and inherited metabolic disorders. Swedish Orphan
Biovitrum had
pro-forma revenues 2009e of about 2 BSEK and approximately 500
employees. The
head office is located in Sweden and the share (STO: SOBI) is listed on
NASDAQ
OMX Stockholm. For more information please visit www.sobi.com.
For more information please contact: Swedish Orphan Biovitrum AB (publ):
Erik Kinnman, VP Investor Relations
Phone: +46 73 422 15 40
E-mail erik.kinnman@sobi.com
Peter Edman, CSO
Phone. +46 8 697 21 77
E-mail peter.edman@sobi.com
Swedish Orphan Biovitrum may be required to disclose the information
provided
herein pursuant to the Swedish Securities Markets Act. The
information was
provided for public release on August 26, 2010 at 8:30 a.m. CET.
[HUG#1440325]
Press release in PDF format:
http://hugin.info/134557/R/1440325/384692.pdf
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Source: Swedish Orphan Biovitrum AB (publ) via Thomson Reuters ONE
