STOCKHOLM, SWEDEN--(Marketwire - July 06, 2012) -
Sobi has filed an application for Kineret® (anakinra) for the indication
neonatal-onset multisystem inflammatory disease (NOMID) with the Federal Drug
Administration (FDA) in the US. The filing is made under an Orphan Drug
Designation for the indication cryopyrin associated periodic syndromes (CAPS),
which was granted in 2010. If the application is granted priority review, Sobi
expects a review period of 6-8 months.
The basis for the filing is a clinical trial initiated and conducted by
Principal Investigator Dr Raphaela Goldbach-Mansky at the National Institute
Arthritis and Musculoskeletal and Skin Diseases (NIAMS), at NIH in Bethesda,
The trial which includes a majority of NOMID patients in the US has gathered
extensive long-term treatment data.
"We are delighted to be taking this important step for infants, children and
adults with NOMID" said Sobi CEO Geoffrey McDonough. "This is the outcome of a
strong collaboration with the NIH and reflects our shared commitment to the
orphan drug community and to supporting the pediatric rheumatology field."
"The awareness and understanding of NOMID has increased significantly in the
last couple of years", said Mrs. Karen Durrant, President of The NOMID
- a non-profit organization for patients with CAPS and other autoinflammatory
diseases. "However, there is still an unmet medical need for these severely
patients and an FDA approved therapy for this drug would greatly facilitate
access to reimbursed medication."
About CAPS and NOMID
Cryopyrin associated periodic syndromes (CAPS) is a rare, autosomal dominant
disease consisting of three autoinflammatory conditions of varying severity
oftentimes overlapping symptoms. At the milder end it is characterized by
long, cold-induced inflammatory episodes of fever, rash and malaise. When of
intermediate severity, it is typically associated with more intense and
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), it is
associated with increased mortality and nearly continuous fevers, rash,
aseptic meningitis, sensorineural involvement, craniofacial abnormalities, and
exuberant bone lesions. The incidence of NOMID is estimated to be less than
CAPS is characterized by uncontrolled overproduction of IL-1β. IL-1
a number of inflammatory responses such as fever, pain sensitization, bone and
cartilage destruction and acute plasma protein response.
Kineret, which is part of Sobi's Core Products business line, 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, which is expressed in a wide variety of tissues and organs. IL-1 is
key mediator of inflammation and driver of autoinflammatory diseases in both
adults and children.
Healthcare professionals should refer to and rely upon the PDR (Physician's
Reference) or the corresponding national labeling texts.
Swedish Orphan Biovitrum (Sobi)
Sobi is a leading integrated biopharmaceutical company dedicated to bringing
innovative therapies and services to improve the health of rare disease
and their families. The product portfolio comprises about 45 marketed products
as well as projects in the late clinical phase. Key therapeutic areas are
Inflammation and Genetics & Metabolism. In 2011, Sobi had revenues of SEK 1.9
billion and around 500 employees. The share (STO: SOBI) is listed on NASDAQ
Stockholm. More information is available at www.sobi.com.
Sobi press release July 6, 2012:
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Source: Swedish Orphan Biovitrum AB (publ) via Thomson Reuters ONE