FDA approves Ruconest from Pharming, Salix
Pharming Group N.V. (Euronext:PHARM) jumped EUR 0.08 (17%) to EUR 0.54 on Thursday after FDA approved a resubmitted BLA for Ruconest conestat alfa to treat acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE). Partner Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) plans to launch the product -- a recombinant human complement 1 (C1) esterase -- in the U.S. later this year, but is not disclosing pricing. Salix gained exclusive, North American commercialization rights to Ruconest through its January acquisition of Santarus Inc. Ruconest is already marketed in the EU for HAE.
Ruconest will compete in a crowded HAE space that includes fellow C1 esterase inhibitors Cinryze from Shire plc (LSE:SHP; NASDAQ:SHPG) and Berinert C1-INH concentrate from CSL Ltd. (ASX:CSL). ...