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

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. (

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

Contact at Boehringer Ingelheim:
Heidrun Thoma
Corporate Communications
Boehringer Ingelheim GmbH
55216  Ingelheim/Germany
Phone: +49/6132 77 3966

More information:

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:

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Source: Swedish Orphan Biovitrum AB (publ) via Thomson Reuters ONE

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