|SNTS releases positive top-line results|
|By Staff and Wire Reports|
|Monday, 08 November 2010 02:06|
Santarus, Inc. (NASDAQ:SNTS) reported positive top-line results from a second Phase III trial evaluating the safety and efficacy of budesonide MMX for the induction of remission of mild or moderate active ulcerative colitis. Management projects NDA filing in second half of 2011.
The study results show that budesonide MMX 9 mg taken once daily met the primary endpoint of superiority to placebo (p=0.0047) in achieving clinical remission as measured by the ulcerative colitis disease activity index (UCDAI) score after eight weeks of treatment. This second budesonide MMX Phase III clinical study was conducted in Europe in collaboration with Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals. For full details see link to press release.
“Positive top-line results from the European Phase III study are consistent with those from the U.S. Phase III study that we announced in late September. Both studies indicate that the higher, 9 mg dosage strength of budesonide MMX was statistically superior to placebo for the induction of remission of mild or moderate active ulcerative colitis,” said Gerald T. Proehl, president and chief executive officer of Santarus. “We plan to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) in the second half of 2011, following completion of an extended use study.”
As specified in the statistical analysis plans that were submitted to the FDA for both Phase III studies, a p-value of 0.025 was required to achieve statistical significance for the comparison of each budesonide MMX dosage strength (9 mg and 6 mg) with placebo.
Santarus has scheduled an investor conference call at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) today, November 8, 2010 to discuss this announcement and the company’s third quarter 2010 financial results. Individuals interested in participating in the call may do so by dialing 888-803-8275 for domestic callers, or 706-643-7736 for international callers. A telephone replay will be available for 48 hours following conclusion of the call by dialing 800-642-1687 for domestic callers, or 706-645-9291 for international callers, and entering reservation code 17860587. The live conference call also will be available via the Internet by visiting the Investor Relations section of the company’s website at www.santarus.com and a recording of the call will be available on the company’s website for 14 days following the completion of the call.
Santarus Announces Positive Top-Line Results in E.U. Phase III Clinical Study Evaluating Budesonide MMX in Ulcerative Colitis - http://bit.ly/bUzzKT