Santarus, Inc. (NASDAQ: SNTS) announced today the U.S. commercial launch of UCERIS ™ (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis. UCERIS was approved by the U.S. Food and Drug Administration on January 14, 2013.
UCERIS contains budesonide, a locally acting glucocorticosteroid, in a novel oral tablet formulation that utilizes proprietary MMX ® multi-matrix system colonic delivery technology. The approved dosing regimen for adult patients is one 9 mg tablet taken orally once daily in the morning for up to 8 weeks.
“We believe that UCERIS fills an important therapeutic gap as a new prescription option available to physicians treating patients in the active phase of mild to moderate ulcerative colitis,” said Wendell Wierenga, Ph.D., executive vice president of research and development. “In our pivotal clinical studies, three times more patients achieved clinical remission and mucosal healing with UCERIS compared with patients taking placebo, and no clinically significant differences in glucocorticosteroid side effects were seen versus placebo after eight weeks of treatment.”
William C. Denby, senior vice president of commercial operations said, “For the commercial launch of UCERIS we have added 85 new sales representatives, increasing our total number of sales reps to 235. We will use the entire sales organization to promote UCERIS and ZEGERID ® (omeprazole/sodium bicarbonate) to gastroenterologists, while also continuing to promote our three diabetes/metabolic products to endocrinologists and other physicians.”Mr. Denby added, “In addition to our physician outreach, we recognize that informing patients with ulcerative colitis about UCERIS is key to motivating them to seek treatment for the active phase of their disease. To that end, we are implementing patient education programs through social media and medical information websites to provide patients with helpful information about treatment options.” UCERIS was developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A. Upon first commercial sale of UCERIS, $7 million is payable to Cosmo in cash or Santarus common stock, at Cosmo’s option.