European Phase III clinical trial of budesonide MMX completes patient enrollment

Dec 3 2009

Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, today announced that its collaboration partner, Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals SpA (SIX: COPN), has completed enrollment of 514 patients in the European Phase III clinical trial to evaluate budesonide MMX^® administered over eight weeks for the induction of remission of mild or moderate active ulcerative colitis. This is the first of two induction phase clinical trials being conducted as part of the budesonide MMX Phase III clinical program. Santarus and Cosmo expect to report preliminary top line results from the European Phase III clinical trial in the first half of 2010. The U.S. Phase III budesonide MMX clinical trial is approximately 60% enrolled.

“We are pleased to reach this significant milestone in the budesonide MMX Phase III clinical program,” said Gerald T. Proehl, president and chief executive officer of Santarus. “We look forward to announcing the results of this trial and completing the induction phase of the U.S. budesonide MMX Phase III trial during the first half of 2010.”

Budesonide MMX Phase III Clinical Program

Budesonide MMX is being evaluated for the treatment of ulcerative colitis in two Phase III clinical trials, both of which are intended to support U.S. regulatory submission. The primary endpoint is the percentage of patients achieving clinical remission in each of the budesonide MMX treatment groups versus placebo as measured by the ulcerative colitis disease activity index (UCDAI) after eight weeks of treatment. The Phase III clinical program is expected to enroll approximately 1,000 patients in the two studies.

Each clinical trial is a double-blind, placebo-controlled, four-armed trial.

• The European Phase III clinical trial is comparing a single tablet of budesonide MMX 6 mg or budesonide MMX 9 mg dosed once daily to placebo and to a reference arm using three Entocort EC^® (budesonide) 3 mg capsules dosed once daily (9 mg).
• The U.S. Phase III clinical trial is comparing a single tablet of budesonide MMX 6 mg or budesonide MMX 9 mg dosed once daily to placebo and to a reference arm using two Asacol^® (mesalamine) 400 mg delayed-release tablets dosed three times daily (2.4 grams).

The European and U.S. clinical trials are powered to show a statistical difference between budesonide MMX and placebo. The reference arms using Entocort EC in the European trial and Asacol in the U.S. trial are not powered to show statistical differences versus budesonide MMX.

Additionally, up to approximately 150 patients are expected to continue in a 12-month double-blind extended use trial to evaluate the long term safety and tolerability of budesonide MMX 6 mg and to collect data on the efficacy of budesonide MMX 6 mg in the maintenance of remission of ulcerative colitis compared to placebo. The U.S. Food and Drug Administration (FDA) requested that the results of the 12-month extended use trial be included in the Phase III clinical program to support a U.S. regulatory submission.

The protocols for the budesonide MMX Phase III clinical program were reviewed and approved by the FDA under Special Protocol Assessments.

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