Santarus, Inc. (NASDAQ: SNTS) today announced that results from its CORE II clinical study, one of two of the company’s pivotal Phase III clinical studies with UCERIS ™ (budesonide) extended release tablets in patients with ulcerative colitis, have been published online in the peer-reviewed journal Gut. The article titled, Once-daily budesonide MMX ® in active mild-to-moderate ulcerative colitis: results from the randomized CORE II study can be found online at http://gut.bmj.com/. The results from CORE II indicate that UCERIS 9 mg had a statistically significant benefit over placebo in the primary endpoint of inducing combined clinical and endoscopic remission at week 8 among patients with active, mild to moderate ulcerative colitis. A total of 410 patients across four treatment groups (placebo, UCERIS 9 mg, UCERIS 6 mg and Entocort EC ® 9 mg) were evaluated for efficacy in the CORE II study. The percentage of patients achieving the primary endpoint of combined clinical and endoscopic remission at week 8 in the UCERIS 9 mg group was significantly greater than that seen in the placebo group (17.4% vs. 4.5%, p= 0.0047; odds ratio (OR): 4.49). The U.S. Food and Drug Administration (FDA) approved UCERIS 9 mg for the induction of remission in patients with active, mild to moderate ulcerative colitis on January 14, 2013. “UCERIS 9 mg looks like a useful treatment option for the induction of remission in patients with active, mild to moderate ulcerative colitis,” said Simon P. L. Travis, M.D., Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, United Kingdom and lead author of the article in Gut. Efficacy endpoints were prespecified in the statistical analysis plan to be analyzed in the modified intention to treat (ITT) population (all randomized patients who received at least one dose of study medication, with active histological disease at baseline and no major violations of Good Clinical Practices (GCP) or entry criteria (i.e., infectious colitis)), consistent with the 2008 European Medicines Agency guidelines on clinical trials of active ulcerative colitis. Active disease was determined via a central histopathologist.
UCERIS 9 mg was generally well tolerated and the frequency of treatment emergent adverse events was similar to placebo in the CORE II study. The most frequent treatment emergent adverse events (experienced by ≥ 5.0% of patients in any treatment group) were ulcerative colitis relapse, headache, abdominal pain, flatulence, nausea, nasopharyngitis and blood cortisol decrease. Worsening of potential glucocorticoid-related effects occurred infrequently during the study. The most frequent worsened potential glucocorticoid-related signs or symptoms were mood changes (3.5%), sleep changes (3.3%) and insomnia (1.6%). No notable differences were observed between the active treatment and placebo groups with regard to these effects.Important Safety Information About UCERIS UCERIS is a prescription corticosteroid medicine used to help get mild to moderate ulcerative colitis under control. UCERIS is taken once daily in the morning with or without food for up to 8 weeks.
- Do not take UCERIS if you are allergic to budesonide or any of the ingredients in UCERIS.
- Before you take UCERIS, tell your doctor if you have liver problems, are planning to have surgery, have chickenpox or measles or have recently been near someone with chickenpox or measles, have or had a family history of diabetes, cataracts or glaucoma, have high blood pressure (hypertension), decreased bone mineral density (osteoporosis), stomach ulcers, any other medical condition, are pregnant or plan to become pregnant, or breastfeed or plan to breastfeed.
- Tell your doctor about all the medications you take, including prescription and over-the-counter vitamins and herbal supplements. UCERIS and other medicines may affect each other causing side effects.
- Do not eat grapefruit or drink grapefruit juice while taking UCERIS because these can increase the level of UCERIS in your blood.
- Long-time use of UCERIS can cause you to have too much glucocorticosteroid medicine in your blood (hypercorticism). Tell your doctor if you have any of the following signs and symptoms of hypercorticism: acne, bruise easily, rounding of your face (moon face), ankle swelling, thicker or more hair on your body and face, a fatty pad or hump between your shoulders (buffalo hump), or pink or purple stretch marks on the skin of your abdomen, thighs, breasts, and arms.
- When UCERIS is taken for a long period of time, the adrenal glands do not make enough steroid hormones. Tell your doctor if you are under stress or have any symptoms of adrenal suppression during treatment with UCERIS, including tiredness, weakness, nausea and vomiting, and low blood pressure.
- UCERIS weakens your immune system. Taking medicines that weaken your immune system makes you more likely to get infections. Avoid contact with people who have contagious diseases such as chickenpox or measles while taking UCERIS. Tell your doctor about any signs or symptoms of infection, including fever, pain, aches, chills, feeling tired, or nausea and vomiting.
- If you take certain other corticosteroid medicines to treat allergies (e.g., eczema, rhinitis), switching to UCERIS may cause your allergies to come back. Tell your doctor if any of your allergies become worse while taking UCERIS.
- The most common side effects with UCERIS are headache, nausea, decreased blood cortisol levels, stomach-area pain, tiredness, stomach or intestinal gas, bloating, acne, urinary tract infection, joint pain, and constipation.
Phase III Clinical Study (CORE* I and II) Design* COlonic RElease budesonide for the treatment of mild to moderate ulcerative colitis UCERIS was evaluated for the treatment of active, mild to moderate ulcerative colitis in two multicenter, randomized, double-blind, double-dummy, placebo-controlled four-arm Phase III clinical studies. The primary endpoint was the induction of combined clinical and endoscopic remission, defined as an overall Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1 after 8 weeks of treatment with subscores of 0 for both rectal bleeding and stool frequency, a normal colonic mucosa without any sign of friability, and ≥ 1 point reduction from baseline in the endoscopic score.
- CORE I was conducted in North America and India and compared UCERIS 9 mg or 6 mg dosed once daily to placebo. The study included a reference arm utilizing a dose of two Asacol (mesalamine) 400 mg delayed-release tablets dosed three times a day resulting in a total of 2.4 grams daily. The study enrolled a total of 509 patients.
- CORE II was conducted in Europe, Australia, Israel, and Russia and compared UCERIS 9 mg or 6 mg dosed once daily to placebo. The study included a reference arm that utilized a dose of three Entocort® EC 3 mg capsules resulting in a once-daily dose of 9 mg. The study enrolled a total of 511 patients.
About SantarusSantarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company's current commercial efforts are focused on five products. UCERIS™ (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis and ZEGERID® (omeprazole/sodium bicarbonate) for the treatment of certain upper gastrointestinal disorders are promoted to gastroenterologists. GLUMETZA® (metformin hydrochloride extended release tablets) and CYCLOSET® (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes, and FENOGLIDE® (fenofibrate) tablets, which is indicated as an adjunct to diet to reduce high cholesterol, are promoted to endocrinologists and other physicians who treat patients with type 2 diabetes. Full prescribing and safety information for Santarus’ products are available at www.santarus.com. Santarus’ product development pipeline includes the investigational drug RUCONEST ® (recombinant human C1 esterase inhibitor) for treatment of acute attacks of hereditary angioedema. The company expects to submit a biologics license application (BLA) to the U.S. Food and Drug Administration for RUCONEST in the second quarter of 2013. Santarus is also developing rifamycin SV MMX ®, which is in Phase III clinical testing for treatment of travelers’ diarrhea. In addition, the company has completed a Phase I clinical program with SAN-300, an investigational monoclonal antibody. More information about Santarus is available at www.santarus.com. Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans or objectives will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus’ business, including, without limitation: unexpected adverse side effects or inadequate therapeutic efficacy of Santarus’ products and product candidates; the scope and validity of patent protection for Santarus’ products and product candidates; and other difficulties or delays relating to the development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus’ products and product candidates; and other risks detailed in Santarus’ prior press releases as well as in prior public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Santarus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. Santarus ® , FENOGLIDE ® , UCERIS ™ and ZEGERID ® are trademarks of Santarus, Inc. GLUMETZA ® is a trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. CYCLOSET ® is a trademark of VeroScience LLC. MMX ® is a trademark of Cosmo Technologies Limited. RUCONEST ® is a trademark of Pharming Group N.V.