The Associated Press September 29, 2010, 6:40PM ET

Santarus says colitis drug met goal in study

Santarus Inc. said Wednesday its drug candidate budesonide MMX met its goal in a late-stage clinical trial as a treatment for ulcerative colitis.

Santarus said a 9-milligram dose of budesonide MMX was significantly better than a placebo at putting patients in remission after eight weeks. A 6-milligram dose was not more effective than the placebo.

Shares of Santarus jumped in aftermarket trading, rising 30 cents, or 10.7 percent, to $3.10.

Patients in the study had mild or moderate ulcerative colitis, a bowel disease that causes inflammation and ulcers inside the colon. The San Diego company said 123 patients took the larger dose of budesonide MMX, and 22 of them were in remission at the end of the study. It said 124 patients took an older drug, Asacol, and 15 were in remission. Nine out of 121 patients who took the placebo were in remission at the end of eight weeks.

The results were from one of two late-stage trials of budesonide MMX being run by Santarus and its partner, Cosmo Pharmaceuticals SpA. The other study is based in Europe. The companies plan to file for marketing approval of the 9-milligram dose in late 2011.

The two companies are also studying extended use of the 6-miligram dose in a trial that is scheduled to end in mid-2011.

Shares of Santarus fell 5 cents to $2.80 during the day. The stock has traded between $2.09 and $5.82 during the last year.


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