Santarus Submits New Drug Application to FDA for UCERIS (budesonide) Tablets



Santarus, Inc. (NASDAQ:SNTS) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking market approval for UCERIS™ (budesonide) Tablets 9 mg for the induction of remission of mild to moderate active ulcerative colitis. UCERIS, a locally acting, nonsystemic corticosteroid in a novel, patented, oral tablet formulation, utilizes proprietary MMX® multi-matrix system technology that is designed to result in the controlled release and distribution of budesonide throughout the length of the colon. UCERIS is being developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A.

UCERIS was evaluated for the treatment of patients with mild or moderate active ulcerative colitis in two Phase III pivotal clinical studies. In these clinical studies, UCERIS 9 mg taken once daily met the primary endpoint of superiority to placebo (p=0.0143 in U.S. study and p=0.0047 in E.U. study) in achieving clinical remission in the intent-to-treat (ITT) population as measured by the ulcerative colitis disease activity index (UCDAI) score after eight weeks of treatment. The ITT population was predefined 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 violations or major entry criteria violations. The Phase III clinical study results also indicated that UCERIS 9 mg was generally well tolerated and the frequency of treatment emergent adverse events was similar to placebo.

The primary endpoint of each Phase III clinical study was the achievement of clinical remission, defined as a UCDAI score < 1 after eight weeks of treatment with a score of 0 for rectal bleeding and stool frequency, and > 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability (an indicator of mucosal inflammation).

Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company’s current commercial efforts are focused on GLUMETZA® (metformin hydrochloride extended release tablets) and CYCLOSET® (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes.

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, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements, which may also strongly affect quality of life. It is believed that as many as 1.2 million people in the U.S. have IBD.

Santarus also has a diverse development pipeline, including three investigational drugs in Phase III clinical programs: UCERIS™ (budesonide) Tablets for induction of remission of active ulcerative colitis, RHUCIN® (recombinant human C1 inhibitor) for treatment of acute attacks of hereditary angioedema and rifamycin SV MMX® for treatment of travelers’ diarrhea, in addition to other earlier-stage development programs.

More information about Santarus is available at www.santarus.com.

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