ARTICLE | Company News

Pharming, Santarus deal

September 20, 2010 7:00 AM UTC

Santarus received exclusive rights to commercialize Pharming's Rhucin in North America. The recombinant human complement 1 esterase inhibitor ( rhC1INH) is known as Ruconest in Europe where an MAA is under review by EMA to treat acute angioedema attacks in patients with hereditary angioedema (HAE). Pharming plans to submit a BLA for Rhucin to FDA by January 2011 for the same indication.

Pharming will be responsible for development of Rhucin for HAE and all HAE-related regulatory activities in the U.S. Santarus will be responsible for regulatory approval for the indication in Canada and Mexico. Additionally, Santarus and Pharming will share clinical development costs of Rhucin to treat or prevent renal transplant rejection for which it is in Phase I testing, and Santarus will be responsible for related regulatory activities in the U.S. Santarus will purchase commercial supply of Rhucin from Pharming for a tiered supply price based on a percentage of net sales of Rhucin. Pharming will receive an upfront payment of $15 million and is eligible for milestone payments, including a $5 million payment upon acceptance of the Rhucin BLA by FDA. ...