PDUFA: Oct 16 — Santarus, Inc **Extended to January 16, 2013**

Santarus, Inc. expects an FDA decision under the Prescription Drug User Fee Act (PDUFA) on the approval status of UCERIS, being developed for the treatment of induction of remission of mild to moderate active ulcerative colitis.

Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists and other physicians. The company has four marketed products: GLUMETZA to improve glycemic control in adults with type 2 diabetes mellitus; CYCLOSET, a first-in-class antidiabetic treatment that may lower blood sugar, without increasing insulin; FENOGLIDE, a fenofibrate prescribed to treat adults with hyperlipidemia; and ZEGERID, a non-promoted revenue-generating product to treat heartburn and other symptoms associated with gastroesophageal reflex disease.

UCERIS is the trade name for topical emollients, a corticosteroid in a novel oral tablet formulation that uses proprietary colonic delivery technology resulting in the controlled release and distribution of budesonide throughout the length of the colon.

Ulcerative colitis occurs in 35–100 people for every 100,000 in the United States, with highest incidences in the United States, Canada, the United Kingdom, and Scandinavia. The ulcerative colitis market is expected grow nearly 6 percent annually to about $3 billion by 2020.

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