Santarus Inc. (SNTS) recently announced that it has finished enrolling patients for a phase III study that is being conducted in Europe with pipeline candidate, budesonide MMX. Santarus is developing the candidate in collaboration with Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals SpA.

Budesonide MMX is being evaluated for the treatment of ulcerative colitis. The partners are conducting another phase III study with the candidate in the US, which is approximately 60% enrolled. The primary endpoint of the trials is the percentage of patients who achieve clinical remission in each of the budesonide MMX treatment groups compared to placebo as measured by the ulcerative colitis disease activity index (UCDAI) after eight weeks of treatment. A total of 1,000 patients will be studied in the phase III clinical program.

The phase III program is being carried out under the US Food and Drug Administration’s (FDA) Special Protocol Assessment (SPA) process. We expect to see preliminary top line results from the European phase III study in the first half of 2010.

In addition to in-licensing budesonide MMX from Cosmo in December 2008, Santarus in-licensed another late stage pipeline candidate from Cosmo ? rifamycin SV MMX. We believe both products fit well with the company’s focus on the gastrointestinal (GI) market. While budesonide will target mild-to-moderate ulcerative colitis, rifamycin is being investigated for the treatment of traveler’s diarrhea.

If developed successfully, the company should be in position to file a new drug application (NDA) for budesonide MMX in the second half of 2011. Meanwhile, the NDA filing for rifamycin SV MMX should come in 2012. Annual peak sales of budesonide MMX and rifamycin SV MMX could be in the range of $150 million ? $250 million and $50 million ? $150 million, respectively. We currently have a Neutral recommendation on Santarus.

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