SOBI gains EMA approval for change of Kineret producer; Novartis drops NIC002 project

Swedish Orphan Biovitrum (STO: SOBI) has received approval from the European Medicines Agency for the manufacture of drug substance for Kineret (anakinra) at German independent drug major 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 Food and Drug Administration, which earlier this month approved marketing of the drug for the treatment of children and adults with neonatal-onset multisystem inflammatory disease (NOMID; The Pharma Letter January 8), and authorities in other countries where Kineret is approved. The drug, discovered and developed by Amgen and in 2008 licensed to SOBI, was first cleared in the USA in 2001 for rheumatoid arthritis.

Geoff McDonough, chief executive of SOBI, stated: "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."