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Kineret® receives Australian regulatory approval for use in Systemic Juvenile Idiopathic Arthritis

Press Release   •   Aug 19, 2015 08:33 GMT

Swedish Orphan Biovitrum AB (publ) (Sobi) together with its Australian partner, A. Menarini Australia Pty Ltd received marketing authorisation in Australia for Kineret (anakinra) for the treatment of systemic juvenile idiopathic arthritis (SJIA), which is a rare form of juvenile chronic arthritis.

“We are pleased and encouraged by this approval which was achieved through a fruitful collaboration between physicians, regulators, and our development team including Menarini,” says Kristina Timdahl, Medical Therapeutic Area Head for the business area Inflammation at Sobi, “We are looking forward to serving a wider group of patients in Australia going forward.”

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About SJIA

Systemic juvenile idiopathic arthritis (SJIA) is a rare form of chronic arthritis in children up to 16 years of age. About 100 of 100,000 children are affected by child arthritis, and of these 10-20 percent have the sJIA form, today classified as an autoinflammatory disease. The disease does not only cause inflammation of the joints but also fever spikes, rash, anaemia, and enlargement and inflammation of major organs. Despite treatment, many children suffer life-long and serious complications such as osteoporosis and stunted growth.

About Kineret

Kineret (anakinra) is a recombinant protein drug that blocks the biological activity of IL-1α and IL -1ß 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.

About A.Menarini Australia

A member of the Menarini Group, a leading European biopharmaceutical company, Menarini Australia is focused on delivering differentiated ethical and consumer healthcare brands to Australians. With an extensive brand portfolio, Menarini Australia markets a wide range of pharmaceutical, biotechnology and consumer health brands. Building on our strengths in dermatology, primary care, consumer health and specialty care, Menarini Australia is now introducing new products in men’s sexual health, cardiovascular and allergy/respiratory therapeutic areas. For further information please visit www.menarini.com.au

About 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 primarily focused on Haemophilia, Inflammation and Genetic diseases. We also market a portfolio of specialty and rare disease products for partner companies across Europe, the Middle East, North Africa and Russia. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2014, Sobi had total revenues of SEK 2.6 billion (USD 380 M) and about 600 employees. The share (STO: SOBI) is listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com.

For more information please contact 
Media relations 
Oskar Bosson, Head of Communications 
T: +46 70 410 71 80
oskar.bosson@sobi.com

 Investor relations
Jörgen Winroth, Vice President, Head of Investor Relations 
T: +1 347-224-0819, +1 212-579-0506, +46 8 697 2135  
jorgen.winroth@sobi.com