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Agreement

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Date: 2010-09-13
Biotech partner: Pharming (The Netherlands) Santarus (USA)
Type of agreement: * commercialization/ distribution
Compound: Rhucin® (recombinant human C1 inhibitor; Ruconest® in Europe)
Disease area: acute angioedema attacks in patients with Hereditary Angioedema (HAE) and other future indications
Development phase: On June 24, the European Medicines Agency adopted a positive opinion for Ruconest™ (Rhucin® in non-EU territories) for the treatment of angioedema attacks. Market Authorization in the European Economic Area is therefore expected imminently with an anticipated market launch in the fourth quarter 2010.
Nature of the agreement: Pharming has entered into an agreement with Santarus, Inc for the commercialization of Rhucin® (recombinant human C1 inhibitor; Ruconest® in Europe) in North America (the United States, Canada and Mexico) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE) and other future indications.Pharming is responsible under the agreement for the clinical development of Rhucin® for HAE and all HAE related regulatory activities in the US, whereas Santarus will be responsible for regulatory approval in Canada and Mexico. In addition, Santarus and Pharming will share responsibility and costs for the clinical development of Rhucin for the treatment or prevention of renal transplantation rejection. Santarus will be responsible for related regulatory activities in North America.
Termes financiers

Financial terms of the agreement: Santarus will pay Pharming a $15 million upfront fee upon signing. Furthermore, Santarus will pay a $5 million milestone payment upon acceptance of the Rhucin® Biologic License Application (BLA) by the FDA. Additional payments are payable upon completing clinical and commercial milestones. Santarus will purchase its commercial supply of Rhucin® from Pharming at a tiered supply price, based on a percentage of net sales of Rhucin.


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