Sobi gets FDA approval to manufacture substance for Kineret® with partner Boehringer Ingelheim

Swedish Orphan Biovitrum AB (publ) (Sobi) today announced receipt of approval
from the Food and Drug Administration (FDA) 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 in the US, and
comes as the result of a Supplemental Biologics License Application (sBLA) filed
with the FDA in February 2013.

"We are very pleased that the FDA has approved our technology transfer of
Kineret manufacturing from Amgen to Boehringer Ingelheim", said Geoffrey
McDonough, CEO and President of Sobi. "This completes the process and
establishes our supply chain for the long term supply of Kineret."

"Boehringer Ingelheim is excited about this important milestone for Kineret®",
stated Christian Eckermann, Head of Boehringer Ingelheim Biopharmaceuticals site
Austria. "We are happy to continue the long term partnership with Sobi by
supplying Kineret® also to the US market."


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 a
portfolio of 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 2012, Sobi had total revenues of SEK 1.9 billion
(€ 215 M) and about 500 employees. The share (STO: SOBI) is listed on NASDAQ OMX
Stockholm. More information is available at

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. (

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical
companies with net sales of about 14.7 billion Euros in 2012. 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 Boehringer 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.

 For more information please contact (not for publication)


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 Boehringer Ingelheim:

 Heidrun Thoma

 Corporate Communications

 Phone: +49-6132 77 3966



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