Pharming and Salix gain US approval for Ruconest

Netherlands-based Pharming Group (NYSE Euronext: PHARM) and Salix Pharmaceuticals. (Nasdaq: SLXP) have received approval from the US Food and Drug Administration for Ruconest (C1 esterase inhibitor [recombinant]) 50 IU/kg for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE).

Because of the limited number of patients with laryngeal attacks, effectiveness was not established in HAE patients with laryngeal attacks. Salix, which acquired US partnering rights to the drug through its  $2.6 billion purchase of Santarus last year, currently plans on making Ruconest, which is already approved and marketed in Europe, accessible to US patients later in 2014. The company has previously estimated peak annual sales of $100 million for this drug.

“We are pleased that Ruconest provides the HAE community with another FDA-approved option for treating painful and debilitating HAE attacks,” said Anthony Castaldo, president of the Hereditary Angioedema Association (US HAEA), a non-profit patient services and research organization with a membership of over 5,000 HAE patients in the USA.