Santarus Announces Positive Top-Line Results in E.U. Phase III Clinical Study Evaluating Budesonide MMX in Ulcerative Colitis

Santarus, Inc.a specialty biopharmaceutical company, today announced positive top-line results from a second Phase III clinical study evaluating the safety and efficacy of budesonide MMX(R) 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=0.0047) in achieving clinical remission as measured by the ulcerative colitis disease activity index (UCDAI) score after eight weeks of treatment. This second budesonide MMX Phase III clinical study was conducted in Europe in collaboration with Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals.

"Positive top-line results from the European Phase III study are consistent with those from the U.S. Phase III study that we announced in late September. Both studies indicate that the higher, 9 mg dosage strength of budesonide MMX was statistically superior to placebo for the induction of remission of mild or moderate active ulcerative colitis," said Gerald T. Proehl, president and chief executive officer of Santarus. "We plan to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) in the second half of 2011, following completion of an extended use study."

As specified in the statistical analysis plans that were submitted to the FDA for both Phase III studies, a p-value of 0.025 was required to achieve statistical significance for the comparison of each budesonide MMX dosage strength (9 mg and 6 mg) with placebo.

The intent-to-treat (ITT) population was pre-defined in the statistical analysis plan as all randomized patients who received at least one dose of a study drug, excluding patients with normal histology at baseline as determined by biopsy, Good Clinical Practice (GCP) violations or major entry criteria violations.

Santarus and Cosmo Announce Positive Results in U.S. Phase III Study for Colitis drug

Specialty pharmaceutical companies Santarus (NASDAQ:SNTS) and Cosmo Pharmaceuticals (SIX:COPN) announced Thursday their positive results from the phase III clinical study of budesonide MMX for mild or moderate ulcerative colitis, a form of inflammatory bowel disease.

Ulcerative colitis produces inflammation and ulcers along the inside of the colon. The inflammation can interfere with the normal function of the colon, often causing cramping, bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements. It is believed that as many as 1.2 million people in the U.S. have IBD.

The disease is a chronic illness that relapses and then remits on and off again, and there is no known cure. However, up to 30% of patients with mild or moderate ulcerative colitis require add-on therapy to traditional treatment.

The phase III study, which was conducted in the U.S. and India to evaluate the safety and efficacy of the drug, showed that budesonide MMX, when taken once daily, met the primary endpoint by achieving clinical remission after eight weeks of treatment, as measured by the ulcerative colitis disease activity index. Using a dose of 9mg, 18% of patients taking the drug were in remission, versus slightly more than 7% in the placebo arm of the study.

The positive results are considered a step forward for the two companies toward the submission of a new drug application to the U.S. FDA. Results from the European phase III study are expected in November. Santarus and Cosmo Technologies, a subsidiary of Cosmo Pharmaceuticals, are collaborating on the phase III programs together.

"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," said president and CEO of Santarus, Gerald T. Proehl.

The trial results also show that budesonide MMX was generally well tolerated, the company said.

The FDA has 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. The extended study of 123 patients taken from the phase III trials in the U.S., India and Europe will evaluate the long-term safety and tolerability of the drug, as well as collect data on its efficacy in maintaining the remission stage.

Budesonide MMX is a locally acting corticosteroid in an oral tablet formulation, which uses Cosmo's MMX multi-matrix system technology, designed for the controlled release and distribution of budesonide throughout the colon.

Italy-based Cosmo develops therapies for selected gastrointestinal and topically treated skin disorders. The company's pipeline specifically addresses treatments for IBD, such as ulcerative colitis and Crohn's disease, and colon infections.

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

The company's current commercial efforts are focused on Glumetza and Cycloset, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes. It expects to commercially launch Cycloset in November 2010.

Santarus also has a pipeline that includes rifamycin SV MMX, for treatment of travelers' diarrhea and Rhucin, for treatment of acute attacks of hereditary angioedema.