18 June 2013 - 18 June 2013 - US Santarus Inc (NASDAQ:SNTS) and Dutch Pharming Group NV (AMS:PHARM) said Tuesday that their Biologics License Application (BLA) for investigational drug Ruconest (recombinant human C1 esterase inhibitor) 50 IU/kg as a therapy of acute angioedema attacks in patients with hereditary angioedema (HAE) had been accepted by the US FDA.

The partners anticipate the agency to complete the review of the application by April 16, 2014.

The US company has licensed certain exclusive rights from Pharming to market the drug in North America for the aforementioned indication, as well as for other potential future indications. Following the acceptance of the BLA, Pharming is eligible to receive a milestone payment of USD 5 million (EUR 3.7m).

Ruconest (INN conestat alfa) is a recombinant version of the human protein C1 esterase inhibitor, and is produced with Pharming's transgenic technology. It is authorised in Europe as a therapy of acute angioedema attacks in patients with HAE.

(USD 1.0 = EUR 0.748)