Pharming starts new Rhucin trial for FDA approval

Dutch biotech Pharming will start a new clinical trial into its drug Rhucin as it anticipates the US Food and Drug and Administration will soon start the regulatory approval process for the product. Pharming's first product, being marketed as Ruconest in Europe and Rhucin in the United States where it is still awaiting regulatory approval, treats a rare and dangerous inflammation illness called hereditary angioedema (HAE).

In anticipation of a possible need for more clinical data, Pharming and its US partner Santarus said on Tuesday they are starting a Phase IIIb clinical study to evaluate Rhucin, expecting to enrol 50 patients for a 12-18 month study. "Our approach is that our studies are sufficient. But if you wait till the FDA comes back to you (with more questions), you have to wait another year to 18 months," Pharming Chief Financial Chief Karl Keegan told Reuters. "When we did the deal with Santarus, both teams decided it would be a prudent approach to run another trial ... and that if additional data would be required before approval, we would be in a good position to address it." Pharming lodged its Biologics License Application (BLA) for Rhucin to the FDA in late December and the FDA has 60 days to accept the application, triggering the start of the regulatory approval process - a process which is likely extend into 2012.

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