STOCKHOLM, SWEDEN--(Marketwire - Nov 19, 2012) - Sobi (STO: SOBI) has filed an application
for an EU Marketing Authorization with
the European Medicines Agency (EMA) for Kineret® (anakinra) for the
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
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
an expected approval date of 25 December 2012.
"The filing of Kineret for CAPS and NOMID in the EU and the US respectively
important milestones on Sobi's journey to increase our support for the
rheumatology field as well as for the rare disease community as a whole,"
Dr. Geoffrey McDonough, CEO of Sobi. "In reaching these goals, we aim to
an important treatment option to benefit patients affected by
Commenting on Sobi's decision to file, Dr. Marco Gattorno of Gaslini
Hospital in Genova, Italy and Principal Investigator of the Eurofever
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
provide demonstrated safe and effective treatment options to avoid disease
progression leading to organ damage. Each patient is different, and the
of new treatment alternatives would lead to increased flexibility and
opportunities for optimal treatment for all patients."
Cryopyrin associated periodic syndromes (CAPS) consist of three rare,
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,
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
(a condition where amyloid proteins are abnormally deposited in organs
tissues). In the most severe form (NOMID/CINCA), it is associated with
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.
a number of inflammatory responses such as fever, pain sensitization, bone
cartilage destruction and acute plasma protein response.
About Kineret (anakinra)
Kineret is a recombinant protein drug approved for the treatment of
arthritis (RA). Kineret blocks the biological activity of IL-1 by binding
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
diseases in both adults and children. For more information on Kineret see
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
focused on inflammation and genetic diseases, with three late stage
development projects within hemophilia and neonatology. We also market more
40 products for companies in the specialty and rare disease space. Sobi is
pioneer in biotechnology with world-class capabilities in protein
and biologics manufacturing. In 2011, Sobi had total revenues of SEK 1.9
(EUR 214 M) and about 500 employees. The share (STO: SOBI) is listed on
Stockholm. More information is available at www.sobi.com.
Sobi Press Release on November 19, 2012 in pdf format:
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Source: Swedish Orphan Biovitrum AB (publ) via Thomson Reuters ONE