Netherlands-based biotech firm Pharming Group NV (Euronext: PHARM) says it has entered into an agreement with US specialty biopharmaceutical company Santarus (Nasdaq: SNTS) for the commercialization of Rhucin (recombinant human C1 inhibitor; trade name Ruconest in Europe) in North America (the USA, Canada and Mexico) for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE) and other future indications.
Under the deal, Santarus will pay Pharming a $15 million upfront fee upon signing and a further $5 million milestone upon acceptance of the Rhucin Biologic License Application (BLA) by the US Food and Drug Administration. Additional payments will be made on 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.
Following pre-BLA discussions with the FDA, Pharming previously revealed that it is preparing the BLA dossier for submission towards the end of this year but no later than January 2011 (The Pharma Letter August 31).
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