Pharming and Santarus file BLA for Ruconest with US FDA
Netherlands-based Pharming Group (NYSE Euronext: PHARM) and US licensee Santarus (Nasdaq: SNTS) have submitted a Biologics License Application (BLA) to the US Food and Drug Administration to obtain marketing approval for Ruconest (recombinant human C1 esterase inhibitor) 50U/kg, an investigational drug for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE).
Santarus licensed certain exclusive rights from Pharming to commercialize Ruconest in North America for the treatment of acute attacks of HAE as well as other potential future indications (The Pharma Letter September 14, 2010). Under the terms of that agreement, Pharming received an upfront $15 million and a $5 million milestone is payable to Pharming on FDA acceptance for review of the BLA for Ruconest.
Clinical backing
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