Kineret® approved in Canada for the treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID)

Swedish Orphan Biovitrum AB (publ) (Sobi™) today announces that Health Canada has approved Kineret® (anakinra) for the treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) in adults, adolescents, children and infants aged eight months and older with a body weight of 10 kg or above. Kineret is already approved in Canada for active rheumatoid arthritis (RA) in patients 18 years of age or older.

“We are very happy to receive the NOMID indication approval from Health Canada. NOMID is a severe inflammatory disease which is associated with chronic meningitis, hearing loss, craniofacial abnormalities, bone lesions and can in very severe cases be potentially life threatening. We believe that Kineret can really make a difference to people living with this rare disease and their families,” says Armin Reininger, Senior Vice President Medical & Scientific Affairs.

“This approval by Health Canada represents an important milestone in our efforts to make innovative therapies available to patients with debilitating and often life-threatening diseases,” says Bob McLay, Vice-President & General Manager, Sobi Canada Inc.

Sobi will provide Kineret for home treatment in a prefilled syringe with a graduated label to allow precise and flexible dosing in children and adults. Kineret is also approved in the U.S. and Europe for the treatment of NOMID and RA, and is a proprietary product developed and made available globally by Sobi.

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About NOMID
Neonatal-onset multisystem inflammatory disease (NOMID) is a rare autoinflammatory disease with an incidence estimated to be 1:1,000,000 worldwide, associated with chronic meningitis, hearing loss, craniofacial abnormalities, bone lesions and increased mortality.

About Kineret®
Kineret® (anakinra) is a recombinant protein drug that blocks the biological activity of IL-1a and IL -1b by binding to interleukin-1 type 1 receptor (IL-R 1), expressed in a variety of tissues and organs, and thereby blocking the interleukin-1 (IL-1) signalling. IL-1 is a key mediator of inflammation and a significant contributor to autoinflammatory diseases. Kineret has a well-characterised safety profile, a quick onset of action and a short half-life.

About Sobi™
Sobi is an international specialty healthcare company dedicated to rare diseases. Sobi’s mission is to develop and deliver innovative therapies and services to improve the lives of patients. The product portfolio is primarily focused on Haemophilia, Inflammation and Genetic diseases. Sobi also markets a portfolio of specialty and rare disease products across Europe, the Middle East, North Africa and Russia for partner companies. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2016, Sobi had total revenues of SEK 5.2 billion (USD 608 M) and about 760 employees. The share (STO: SOBI) is listed on Nasdaq Stockholm. More information is available at www.sobi.com.

Swedish Orphan Biovitrum AB
Postal address SE-112 76 Stockholm, Sweden
Phone: 46 8 697 20 00     www.sobi.com

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