Santarus Inc., a specialty biopharmaceutical company, announced that analysis of top-line safety data from a double blind, multi-centre 12-month extended use study in patients treated daily with either the investigational drug budesonide MMX 6 mg or placebo will be provided as support for the company's planned submission of a New Drug Application (NDA) for budesonide MMX 9 mg to the US Food and Drug Administration (FDA) for the induction of remission of mild or moderate active ulcerative colitis. Santarus had previously announced results from two phase III clinical studies that evaluated the safety and efficacy of budesonide MMX 9 mg over an eight week course of treatment for induction of remission of mild or moderate active ulcerative colitis.

A total of 123 patients were enrolled in the extended use study, which was undertaken to evaluate the long-term safety and tolerability of budesonide MMX 6 mg. Top-line results indicate:

The frequency of treatment related adverse events for budesonide MMX 6 mg (21.0%) was similar to placebo (21.3%). Mean morning plasma Cortisol levels remained within normal limits at all visits for both budesonide MMX 6 mg and placebo. There were no clinically meaningful differences in the numbers of patients with abnormal bone mineral density scans at baseline and end-of-study between budesonide MMX 6 mg and placebo.

“Now that we have the top-line safety data from the extended use study, we are moving forward as planned to submit the NDA in December 2011 for budesonide MMX 9 mg for the induction of remission of mild to moderate active ulcerative colitis,” said Gerald T Proehl, president and chief executive officer of Santarus. “We expect that the data from the extended use study will be presented at an appropriate medical meeting in the future.”

The extended use study also explored the efficacy of budesonide MMX 6 mg in the maintenance of remission of ulcerative colitis compared to placebo, but the study was not powered to show statistical significance. The top-line efficacy analysis indicates that budesonide MMX 6 mg was not statistically different from placebo for the primary endpoint, which was the percentage of patients achieving clinical remission at 1, 3, 6, 9 and 12 months. However, there was a positive trend for the secondary endpoint of clinical relapse, which showed a higher percentage of placebo patients (59.4%) experienced clinical relapse vs. the budesonide MMX 6 mg group (30.8%). Moreover, the median time to clinical relapse was longer in the budesonide MMX group compared to placebo.

The extended use study evaluated patients with mild or moderate ulcerative colitis who had previously been enrolled in the Phase III clinical studies conducted by Santarus in collaboration with Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals S.p.A., at clinical sites in the US, India and Europe. The study was completed (last patient last visit) in late May 2011.

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. Budesonide has topical anti-inflammatory activity and due to an extended first pass effect, has less systemic absorption than other corticosteroids.

Ulcerative colitis is a form of Inflammatory Bowel Disease (IBD) that 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, diarrhoea, bleeding, fatigue, weight loss and frequent bowel movements, which may also strongly affect quality of life.

Ulcerative colitis is a chronic relapsing-remitting illness for which there is no known cure, but with appropriate treatment patients can manage their symptoms. However, it is estimated that up to 30% of patients with mild or moderate ulcerative colitis require add-on therapy to aminosalicylate (5-ASA) drugs. Patients refractive to treatment with 5-ASA drugs typically receive a course of an oral, systemically absorbed corticosteroid, the success of which may be limited by significant side effects. For moderate to severe cases of ulcerative colitis, immunosuppressant drugs or biologic drugs may be prescribed. If the condition does not respond to pharmaceutical therapy and the symptoms are severe, the patient may be referred for surgery.