New RHUCIN study data in acute HAE attacks presented at 7th C1 Inhibitor Deficiency Workshop

May 23 2011

Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, today announced that new data from open-label studies evaluating the efficacy and safety of the investigational drug RHUCIN^® (recombinant human C1 inhibitor) for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) were presented at the 7^th C1 Inhibitor Deficiency Workshop on May 20 - 22, 2011 in Budapest, Hungary.

New data from 194 treatments with RHUCIN in 57 patients with acute HAE attacks were presented at a satellite symposium at the Workshop. The data were from an open-label extension study from one of two randomized controlled studies that formed the basis for regulatory approval in Europe. The median time to beginning of relief of symptoms across treatments for repeat attacks was approximately 60 minutes with an overall response rate of 87% and no relapses. No product-related adverse reactions were observed during this study. This data from the European open-label study is consistent with previously announced results from an open-label extension study conducted in North America. The safety dataset of RHUCIN now includes a total of 714 administrations in 190 subjects.

Additional new open-label data from 34 patients who were treated with RHUCIN for 53 severe acute angioedema attacks involving the upper airways were also presented in a poster session at the Workshop. The median time to beginning of relief of symptoms for these upper airway attacks was 76 minutes (95% confidence interval, 62; 120 min). These results are consistent with previously reported results with RHUCIN for other anatomical locations. The overall response rate in treating these severe and potentially life threatening attacks was 100%; there were no treatment failures and no relapses were reported. In the overall safety analysis of all attacks, including the upper airway attacks, RHUCIN was generally safe and well-tolerated.

"The open-label experience with RHUCIN provides additional data evaluating the safety and efficacy of the drug for the treatment of acute attacks of angioedema in patients with HAE," said Mark C. Totoritis, M.D., Santarus senior vice president, clinical research.