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Santarus Submits NDA For Uceris Tablets To Treat Active Ulcerative Colitis

12/20/2011 7:41 PM ET

Santarus, Inc. (SNTS: Quote) Tuesday said it submitted a New Drug Application or NDA to the U.S. Food and Drug Administration 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.

Upon acceptance for review of the NDA for Uceris Tablets, $4 million is payable to Cosmo Technologies Limited. The milestone is payable in cash or Santarus common stock, at Cosmo's option.

Uceris was evaluated for the treatment of patients with mild or moderate active ulcerative colitis in two Phase III pivotal clinical studies. Uceris 9 mg taken once daily met the primary endpoint of superiority to placebo in achieving clinical remission in the intent-to-treat population as measured by the ulcerative colitis disease activity index or UCDAI score after eight weeks of treatment.

The results also indicated that Uceris 9 mg was generally well tolerated and the frequency of treatment emergent adverse events was similar to placebo.

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.

It is estimated that up to 30 percent 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.

SNTS closed Tuesday's regular trading at $3.21, up $0.10 or 3.22%, on the Nasdaq. Over the past year, the stock traded in a range of $2.40 - $3.70.

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by RTT Staff Writer

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