Santarus, Inc and Cosmo Pharmaceuticals SpA announced positive top-line results from the phase III clinical study conducted in the US and India to evaluate the safety and efficacy of budesonide MMX for the induction of remission of mild or moderate active ulcerative colitis. The study results show that budesonide MMX 9 mg taken once daily met the primary endpoint of superiority to placebo (p=0.0143) in achieving clinical remission as measured by the ulcerative colitis disease activity index (UCDAI) score after eight weeks of treatment. Santarus and Cosmo Technologies Ltd, a subsidiary of Cosmo Pharmaceuticals, are collaborating on the budesonide MMX phase III clinical programme.

"These positive results are a major step toward the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for budesonide MMX 9 mg for the induction of remission of mild or moderate active ulcerative colitis," said Gerald T Proehl, president and chief executive officer of Santarus. "Assuming positive results in the European clinical study we plan to submit the NDA in the second half of 2011 following the completion of an ongoing double-blind, placebo-controlled extended use study."

Mauro Ajani, chief executive officer of Cosmo Pharmaceuticals, said, "We are very pleased to announce positive results for the US study with the 9 mg dose, which further validate the ability of our MMX technology to deliver an active pharmaceutical ingredient directly and efficiently to the colon. We are expecting to have the top-line results from the European Phase III study available in November."

Under the statistical analysis plan submitted to the FDA for each phase III study, to achieve statistical significance the budesonide MMX 9 mg and 6 mg treatment arms required a separate analysis at a p-value of 0.025 compared with the placebo group. The intent-to-treat (ITT) population in the pre-defined statistical analysis plan was all randomized patients who received at least one dose of a study drug, excluding patients with normal histology at baseline as determined by biopsy, or due to Good Clinical Practice (GCP) violations or major entry criteria violations.

Based on the preliminary analysis, remission rates for the ITT drug treatment groups versus placebo are summarized in the table below:

Budesonide MMX is an investigational drug that is a locally acting corticosteroid in a novel, patented, oral tablet formulation, which utilizes Cosmo's proprietary MMX multi-matrix system technology and is designed to result in the controlled release and distribution of budesonide throughout the length of the colon.

Cosmo is a speciality pharmaceutical company that aims to become a global leader in optimised therapies for selected gastrointestinal and topically treated skin disorders.

Santarus is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by specialists, including gastroenterologists, endocrinologists, allergists, immunologists and rheumatologists.