Loss-making Dutch biotech company Pharming Group NV (NYSE Euronext: PHARM) said yesterday that, following the release by Pharming and Santarus (Nasdaq: SNTS) on November 7 of the pivotal Phase III clinical study of Ruconest (recombinant human C1 esterase inhibitor) 50U/kg for the treatment of acute attacks of angioedema in patients with hereditary angioedema (HAE) which met its primary endpoint, and in accordance with the terms of the license agreement between the companies, a $10 million milestone has now been paid by Santarus.
An additional $5 million milestone will be payable to Pharming upon US Food and Drug Administration acceptance of the Biologics License Application (BLA) for review. Pharming and Santarus expect to submit the BLA for Ruconest to the FDA in the first half of 2013.
Sijmen de Vries, Pharming’s chief executive, commented: “We are pleased to have received this $10 million milestone from our partner Santarus, which significantly strengthens our balance sheet and signals the beginning of a new chapter in the development of the company.”
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