Swedish Orphan Biovitrum's Kineret® has Received Orphan Drug Designation in the USA
Stockholm, Sweden - 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 1β (IL-1β). 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-1β 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 visitwww.sobi.com.
For more information please contact: Swedish Orphan Biovitrum AB (publ):
Erik Kinnman, VP Investor Relations
Phone: +46 73 422 15 40
E-mailerik.kinnman@sobi.com
Peter Edman, CSO
Phone. +46 8 697 21 77
E-mailpeter.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.