SAN DIEGO & LEIDEN, Netherlands--(BUSINESS WIRE)--Specialty biopharmaceutical company Santarus, Inc. (NASDAQ: SNTS) and biotech company Pharming Group NV (NYSE Euronext: PHARM) today announced that Pharming has begun an international, multicenter, randomized, placebo-controlled Phase IIIb clinical study evaluating the investigational drug RHUCIN® (recombinant human C1 inhibitor) for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE). Pharming expects to enroll approximately 50 patients in the study, which may provide additional data, if required by the U.S. Food and Drug Administration (FDA), in support of an approval for RHUCIN at the 50 U/kg dose. Data from the study will also be used to provide additional validation of the visual analog scale used in measuring the clinical effects of RHUCIN. The study is expected to be completed in 12 to 18 months.
