Specialty biopharmaceutical company Santarus (NASDAQ:SNTS) announced Monday that its results from a clinical study for budesonide MMX, a drug to treat ulcerative colitis, met the primary endpoint, achieving clinical remission as measured by a disease activity index.
Ulcerative colitis, which is a form of inflammatory bowel disease (IBD), 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. It is believed that as many as 1.2 million people in the U.S. have IBD.
Many patients, however, are resistant to current treatment for ulcerative colitis, and other treatment options are limited because of significant associated side effects.
The second phase III study results show that budesonide MMX taken once daily met the primary endpoint of superiority to placebo in achieving clinical remission, as measured by the ulcerative colitis disease activity index (UCDAI) score after eight weeks of treatment. Of 109 patients using the drug, 17.4% achieved clinical remission, as compared with 4.5% of 89 placebo patients.
Santarus said the results from the European study were consistent with those from its U.S. counterpart, 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 president and CEO Gerald T. Proehl.
Following the completion of a 12-month extended use study, the company plans to submit a new drug application to the US FDA in the second half of next year.
In December of 2008, US rights for Budesonide MMX were in-licensed from Cosmo Pharmaceuticals; based on the results of the U.S. and European studies, Cosmo is entitled to receive a $3.0 million milestone payment.
Santarus uses Cosmo's proprietary drug delivery technology to more directly deliver the corticosteroid budesonide to the lining of the intestine, enhancing the drug's efficacy and safety profile. Santarus estimates US peak sales of Budesonide MMX at $150 to $250 million.
Aside from budesonide, the company has Glumetza and Cycloset, indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes. Santarus is also working on rifamycin SV MMX, for the treatment of travelers' diarrhea, and RHUCIN for the treatment of acute attacks of hereditary angioedema.
Disclosure: no position