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

11 June 2013

Swedish Orphan Biovitrum (STO: SOBI) said today (June 11) that it has received approval from the US Food and Drug Administration for the manufacture of drug substance for Kineret (anakinra) at German family-owned drug major Boehringer Ingelheim's microbial site in Vienna, Austria.

The approval allows for distribution of Kineret in the USA, and comes as the result of a Supplemental Biologics License Application (sBLA) filed with the FDA in February 2013. The drug, discovered and developed by US biotech firm Amgen (Nasdaq: AMGN), was licensed to SOBI in 2008. The drug will be co-promoted in the USA with Savient Pharmaceuticals (Nasdaq: SVNT).

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

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