Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, today announced the completion of enrollment of 510 patients in a U.S. Phase III clinical study to evaluate budesonide MMX ® administered over eight weeks for the induction of remission of mild or moderate active ulcerative colitis. This is the second Phase III clinical study being conducted in collaboration with Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals SpA (SIX: COPN), as part of the budesonide MMX Phase III clinical program for U.S. registration. Enrollment in a European Phase III clinical study was completed in December 2009. “Completing enrollment in the U.S. Phase III clinical study marks another major clinical milestone for budesonide MMX in our advancement toward U.S. registration,” said E. David Ballard, II, senior vice president, clinical research and medical affairs of Santarus. “We currently expect to announce top-line results from the European Phase III study late in the second quarter of 2010 and results from the U.S. study in the second half of 2010.” As previously reported, the U.S. Food and Drug Administration (FDA) requested that the results from an additional 12-month extended use study be included in the Phase III clinical program to support a U.S. regulatory submission. Up to approximately 150 patients from the Phase III clinical studies in the U.S. and Europe are being enrolled in this double-blind, placebo-controlled extended use study, which will evaluate the long-term safety and tolerability of budesonide MMX 6 mg and collect data on the efficacy of budesonide MMX 6 mg in the maintenance of remission of ulcerative colitis compared to placebo. Assuming successful and timely completion of the budesonide MMX Phase III clinical program, Santarus plans to submit a New Drug Application (NDA) for budesonide MMX to the FDA in the second half of 2011. Budesonide MMX Phase III Clinical Program Budesonide MMX is being evaluated for the treatment of mild or moderate active ulcerative colitis in two Phase III clinical studies, both of which are intended to support U.S. regulatory submission. The primary endpoint is the achievement of clinical remission as measured by the ulcerative colitis disease activity index (UCDAI) score after eight weeks of treatment.
Each clinical study is a double-blind, placebo-controlled, four-arm study.