Santarus, Inc. (NASDAQ: SNTS) 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.



Santarus, Inc. yesterday 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. 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.

For more information about Santarus, please visit: www.santarus.com

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