STOCKHOLM, SWEDEN--(Marketwire - August 26, 2010) - Swedish Orphan Biovitrum (STO: SOBI)
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
potentially lethal. CAPS is characterized by excessive production
endogenous inflammatory protein interleukin 1B (IL-1B).
Kineret® is a
recombinant version of the naturally occurring IL-1 receptor antagonist
blocks the IL-1 receptor.
"The orphan drug designation (ODD) is an important step in our
document Kineret for the severe and very debilitating disease CAPS. An ODD
advantages in FDA assistance, user-fee benefits and, after orphan
registration, seven years of market exclusivity. This will help us
efforts to offer this potentially very valuable product to CAPS patients
high unmet medical needs." said Peter Edman, Ph.D., Chief Scientific
Swedish Orphan Biovitrum.
About cryopyrin-associated periodic syndromes (CAPS)
Cryopyrin-associated periodic syndromes are members of a
autoinflammatory diseases. CAPS is a rare, autosomal dominant disease
of three autoinflammatory conditions of varying severity and
overlapping symptoms. At the milder end it is characterized by life-
cold-induced inflammatory episodes of fever, rash and malaise.
intermediate severity, it is typically associated with more intense and
flares and morbidity including progressive hearing loss and kidney
secondary to amyloidosis (a condition whereamyloid proteins are
deposited in organs and/or tissues). In the most severe form
associated with high mortality and nearly continuous fevers, rash,
aseptic meningitis, sensorineural involvement, craniofacial
exuberant bone lesions. The incidence is estimated to be
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
bone and cartilage destruction and acute plasma protein response.
20% of untreated children with NOMID/CINCA syndrome die before reaching
About Kineret® (anakinra)
In December 2008, Swedish Orphan Biovitrum obtained from Amgen the
exclusive rights to Kineret® for rheumatoid arthritis as currently
its label. In November 2009, the agreement regarding Swedish Orphan
Kineret® license was expanded to include certain orphan indications.
about Kineret® can be found at the following site:
Healthcare professionals should refer to and rely upon the PDR (Physician's
Reference) or the corresponding national labeling texts.
About Swedish Orphan Biovitrum
Swedish Orphan Biovitrum is a Swedish based niche specialty
company with an international market presence. The company is
providing and developing specialist pharmaceuticals for rare disease
with high medical needs. The portfolio consists of about 60 marketed
and an emerging late stage clinical development pipe-line. Our focus areas
hemophilia, inflammation/autoimmune diseases, fat malabsorption,
supportive care and inherited metabolic disorders. Swedish Orphan
pro-forma revenues 2009e of about 2 BSEK and approximately 500
head office is located in Sweden and the share (STO: SOBI) is listed on
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
Peter Edman, CSO
Phone. +46 8 697 21 77
Swedish Orphan Biovitrum may be required to disclose the information
herein pursuant to the Swedish Securities Markets Act. The
provided for public release on August 26, 2010 at 8:30 a.m. CET.
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Source: Swedish Orphan Biovitrum AB (publ) via Thomson Reuters ONE