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Sobi receives EMA approval to manufacture Kineret® drug substance with partner Boehringer Ingelheim


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Copyright © Thomson Reuters 2013. All rights reserved.
2013-01-23 08:32:56 -

Ingelheim, Germany/Stockholm, Sweden, 23 February 2013 - Sobi (STO: SOBI)
announced receipt of approval from the European Medicines Agency (EMA) for the
manufacture of drug substance for Kineret® (anakinra) at Boehringer Ingelheim's
microbial site in Vienna, Austria. The approval allows for distribution of
Kineret to EMA territory countries, and comes as the result of an application
filed with the EMA in October of 2012. A similar application has been filed with
the US FDA and authorities in other countries where Kineret is approved.

Geoff McDonough, CEO of Sobi states, "This marks an important milestone in the
process of technology transfer of Kineret manufacturing from Amgen to Boehringer
Ingelheim. We are pleased with the progress we are making with our partners in
this regard."

"Kineret is an important commercial product for both 
companies. We have already started to ramp up manufacturing to ensure reliable supply to the market", stated Dr. Lothar Halmer, Site Head Biopharma Austria at Boehringer Ingelheim RCV GmbH & Co KG. About Boehringer Ingelheim The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies with net sales of about 13.2 billion Euros in 2011. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine. All activities of the biopharmaceutical contract manufacturing are performed within the Boehringer Ingelheim Biopharmaceuticals GmbH, headquartered in Ingelheim, Germany and are represented by its new brand Boehnger Ingelheim BioXcellence(TM). As a leading biopharmaceutical contract manufacturer with more than 35 years of experience - the company has brought more than 20 biopharmaceutical products to market. Boehringer Ingelheim BioXcellence(TM) offers tailor-made contract development and manufacturing services to the biopharmaceutical industry, providing the entire production technology chain from DNA to fill and finish under one roof at its facilities in Biberach (Germany), Vienna (Austria) and Fremont (USA). Boehringer Ingelheim BioXcellence(TM) can secure product supply throughout the entire product lifecycle-transferring customer projects at any stage, delivering to almost any scale and thereby makes outsourcing easy. About Kineret® (anakinra) Kineret is a recombinant protein drug approved for the treatment of children and adults with NOMID, and the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis (RA), in patients 18 years of age or older who have failed one or more disease modifying antirheumatic drugs (DMARDs). Kineret blocks the biological activity of IL-1 by binding to the 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 autoinflammatory diseases in both adults and children. For more information on Kineret see the Prescribing Information. (www.kineretrx.com) 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 inflammation and genetic diseases, with three late stage biological development projects within hemophilia and neonatology. We also market more than 40 specialty and rare disease products for partner companies. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2011, Sobi had total revenues of SEK 1.9 billion (€ 214 M) and about 500 employees. The share (STO: SOBI) is listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com Contact at Boehringer Ingelheim: Heidrun Thoma Corporate Communications Boehringer Ingelheim GmbH 55216  Ingelheim/Germany Phone: +49/6132 77 3966 Heidrun.Thoma@boehringer-ingelheim.com Twitter: www.twitter.com/boehringer More information: www.bioxcellence.com bioxcellence@boehringer-ingelheim.com Contact at Sobi: Birgitte Volck, Senior Vice President Development, Chief Medical Officer Phone: +46 8 697 20 94 Sobi Press Release on January 22, 2013, in PDF format: hugin.info/134557/R/1672314/543833.pdf This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that: (i) the releases contained herein are protected by copyright and other applicable laws; and (ii) they are solely responsible for the content, accuracy and originality of the information contained therein. Source: Swedish Orphan Biovitrum AB (publ) via Thomson Reuters ONE [HUG#1672314]


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