Pharming Group (PHARM)

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Pharming Amends Phase III Clinical Study With Rhucin In Acute Hereditary Angioedema Leiden, The Netherlands, May 5th, 2011. Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today announced that following discussions with the U.S. Food and Drug Administration (FDA), Pharming and its U.S. commercialization partner, Santarus, Inc. have submitted an amendment to the protocol for the RHUCIN® (recombinant human C1 inhibitor) Phase III clinical study into which the first patient was enrolled in February 2011.? The Phase III clinical study is evaluating the investigational drug RHUCIN for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE). Pharming still anticipates that the Phase III study will be completed within 12 to 18 months from its original initiation.

On March 31st , Pharming and Santarus met with the FDA to discuss the FDA refusal to file letter received in February 2011 and to gain further clarification on the protocol for the ongoing study to support the RHUCIN Biologics License Application (BLA).? Based on input from the FDA and from the FDA meeting minutes, Pharming and Santarus have now submitted an amendment to the protocol, including an increase of the number of patients from 50 to approximately 75 and a modification to the manner in which the primary endpoint will be assessed. This modification eliminates the need for further validation of the visual analog scale.?

“We are pleased to be working closely with the FDA to amend the protocol for the Phase III study, which we believe addresses the issues raised by the agency, and upon successful completion of the study, will provide the additional clinical support requested for our future BLA submission” said Rienk Pijpstra, MD, MBA, Chief Medical Officer at Pharming.