Santarus, Inc recently announced that results from the CORE II clinical study were published in the journal Gut. The study, conducted in Europe, Australia, Israel and Russia, is one of the main phase III programs evaluating Uceris extended release tablet in patients suffering from active, mild to moderate ulcerative colitis.
Results showed that the 9 mg dose of Uceris had a statistically significant benefit over placebo in meeting the primary endpoint. The primary endpoint was the induction of combined clinical and endoscopic remission at week 8 in patients with active, mild to moderate ulcerative colitis.
Uceris 9 mg was found to be well tolerated by the patients. The adverse events observed in the Uceris 9 mg arm were similar to placebo. No important clinical differences were found between Uceris and placebo in relation to glucocorticoid-related symptoms.
We remind investors that on Jan 14, 2013, Uceris 9 mg received approval from the US Food and Drug Administration (FDA) for the induction of remission in patients with active, mild to moderate ulcerative colitis. The product was launched in the US in Feb 2013.
Santarus is focused on the commercialization of Uceris and is promoting the product to gastroenterologists, endocrinologists and other selected physicians.
We remind investors that companies like AstraZeneca (AZN - Analyst Report) and Salix Pharmaceuticals Ltd have a presence in the ulcerative colitis market.
Santarus currently carries a Zacks Rank #3 (Hold). Meanwhile, Array BioPharma, Inc. (ARRY - Snapshot Report) looks well-positioned in the biopharma space. Array BioPharma carries a Zacks Rank #2 (Buy).