The US Food and Drug Administration (FDA) has approved Santarus' Uceris (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis. The company expects to commence the commercial launch of Uceris in March 2013.

Uceris contains budesonide, a corticosteroid, 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. Uceris was developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A.

"The FDA approval of Uceris provides an important new therapeutic option to patients and physicians for the treatment of active, mild to moderate ulcerative colitis," said William J. Sandborn, chief, division of gastroenterology, director, University of California San Diego (UCSD) IBD Center and professor of clinical medicine, UCSD Health System. "Specifically, Uceris is indicated for use in the induction of remission of active disease, an acute phase of the disease often characterized by cramping, bloating, diarrhoea, bleeding, fatigue, weight loss and frequent bowel movements."

Gerald T. Proehl, president and CEO of Santarus, said, "We are pleased to provide a new option for patients to treat the active phase of mild to moderate ulcerative colitis. With the incremental revenue from Uceris and continued growth in our marketed products, we anticipate another robust year of solid financial results for Santarus in 2013. We expect total revenues of $320 million to $325 million, representing significant double-digit growth over our 2012 revenue guidance."

Proehl continued, "We are adding 85 new sales representatives, thereby increasing our total number of sales reps to 235, to facilitate a strong commercial launch of Uceris. Our expanded commercial organization will promote both Uceris and Zegerid (omeprazole/sodium bicarbonate) to gastroenterologists in addition to promoting our three diabetes/metabolic products to endocrinologists and other physicians."

Ulcerative colitis is a form of chronic inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon, which can interfere with the normal function of the colon. The disease typically starts to manifest in patients as young adults. Ulcerative colitis is an intermittent disease with periods of exacerbated symptoms, or flares, and periods that are relatively symptom-free. Although the symptoms of ulcerative colitis may resolve without treatment, the disease usually requires medication to go into remission. According to the Crohn's and Colitis Foundation of America, as many as 700,000 people in the U.S. suffer from 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 physician specialists.