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Santarus Announces Presentation of Pooled Data from Budesonide MMX Phase III Clinical Studies at the ACG Annual Scientific Meet

^{Published on 2011-11-01 01:41:44 - Market Wire}
 

SAN DIEGO--([ BUSINESS WIRE ])--[ Santarus, Inc. ] (NASDAQ:SNTS) today announced the presentation of an analysis of pooled data from its two Phase III clinical studies indicating that the investigational drug budesonide MMX 9 mg taken once daily for the induction of remission of mild or moderate active ulcerative colitis was statistically superior to placebo in clinical and endoscopic remission and in symptom resolution. Santarus also announced that it has selected UCERIS^a" as the proprietary trade name for budesonide MMX.

"We are on track to submit the new drug application for UCERIS 9 mg to the FDA by the end of 2011."

The UCERIS 9 mg data will be presented in a poster session (abstract #P1133) today, Tuesday, November 1, 2011, from 12:45 p.m. to 2:15 p.m. Eastern time at the American College of Gastroenterology (ACG) Annual Scientific Meeting being held in Washington, D.C. The poster is titled Induction of Clinical and Endoscopic Remission of Mild to Moderately Active Ulcerative Colitis with Budesonide MMX 9 mg: Analysis of Pooled Data from Two Phase III Studies (W. Sandborn, S. Travis, et al).

aWe believe the results of this pooled analysis of Phase III study data provides important information about UCERIS 9 mg, which is being developed to treat patients with mild or moderate active ulcerative colitis,a said E. David Ballard, M.D., senior vice president of medical affairs and pharmacovigilance at Santarus. aWe are on track to submit the new drug application for UCERIS 9 mg to the FDA by the end of 2011.a

The pooled data from the two Phase III clinical studies analyzed 672 patients in the pre-defined intent to treat (ITT) population who were treated with UCERIS 9 mg Tablets (n=232), UCERIS 6 mg Tablets (n=230) or placebo (n=210). The pooled ITT population excluded study patients without histological evidence of active disease at baseline or with major eligibility or Good Clinical Practice violations. Key findings include:

• Clinical and endoscopic remission for UCERIS 9 mg was 17.7% versus 6.2% for placebo (p=0.0002).
• Symptom resolution was 26.3% for UCERIS 9 mg versus 14.3% for placebo (p=0.0015).
• Clinical improvement (p=0.0572) and endoscopic improvement (p=0.0410) were both numerically greater for UCERIS 9 mg than placebo, but not statistically significant at '=0.025, which was used due to multiple testing of two active treatment arms.
• Treatment-emergent adverse events, including potential glucocorticoid effects, occurred with similar frequencies across all study groups. The most common treatment-emergent adverse events were ulcerative colitis, headache, nausea, abdominal pain, musculoskeletal and connective tissue disorders and nasopharyngitis.

UCERIS (budesonide) Tablets Phase III Study Design

Two Phase III clinical studies were conducted in collaboration with Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals S.p.A., to evaluate UCERIS 9 mg and UCERIS 6 mg for the treatment of mild or moderate active ulcerative colitis. Both Phase III studies are intended to support U.S. regulatory submission. The primary endpoint was the achievement of clinical remission, defined as a UCDAI score a 1 after eight weeks of treatment with a score of 0 for rectal bleeding and stool frequency, and a 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability (an indicator of mucosal inflammation).

Each clinical study was a multicenter, randomized, double-blind, double-dummy, placebo-controlled four-arm study.

• Study CB-01-02/02was conducted in Europe and compared UCERIS 9 mg Tablets or UCERIS 6 mg Tablets dosed once daily to placebo. A reference arm using three Entocort EC 3 mg capsules for a total of 9 mg dosed once daily was also included.
• Study CB-01-02/01 was conducted in the U.S. and India and compared UCERIS 9 mg Tablets or UCERIS 6 mg Tablets dosed once daily to placebo. A reference arm using two Asacol (mesalamine) 400 mg delayed-release tablets dosed three times a day for a total of 2400 mg daily was also included.

The Phase III clinical studies were powered to show a statistical difference between the two UCERIS treatment arms and placebo. The reference arms using Entocort EC in the European study and Asacol in the U.S. study were not powered to show statistical differences versus UCERIS.

About UCERIS (budesonide)

UCERIS (budesonide) is an investigational drug that is a locally acting corticosteroid in a novel, patented, oral tablet formulation, which utilizes proprietary MMX multi-matrix system technology and is designed to result in the controlled release and distribution of budesonide throughout the length of the colon. Budesonide has topical anti-inflammatory activity and due to an extended first pass effect, has less systemic absorption than other corticosteroids.

About Ulcerative Colitis

Ulcerative colitis is a form of inflammatory bowel disease (IBD) that 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, which may also strongly affect quality of life. According to the Crohnas & Colitis Foundation of America, IBD affects an estimated 1.4 million Americans.

Ulcerative colitis is a chronic relapsing-remitting illness for which there is no known cure, but with appropriate treatment patients can manage their symptoms. However, it is estimated that up to 30% of patients with mild or moderate ulcerative colitis require add-on therapy to aminosalicylate (5-ASA) drugs. Patients refractive to treatment with 5-ASA drugs typically receive a course of an oral, systemically absorbed corticosteroid, the success of which may be limited by significant side effects. For moderate to severe cases of ulcerative colitis, immunosuppressant drugs or biologic drugs may be prescribed. If the condition does not respond to pharmaceutical therapy and the symptoms are severe, the patient may be referred for surgery.

About Santarus

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. The companyas current commercial efforts are focused on [ 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.

Santarus also has a diverse development pipeline, including three investigational drugs in Phase III clinical programs: UCERIS^a" (budesonide) Tablets for induction of remission of active ulcerative colitis, RHUCIN (recombinant human C1 inhibitor) for treatment of acute attacks of hereditary angioedema and rifamycin SV MMX for treatment of travelersa diarrhea, in addition to other earlier-stage development programs. 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. These forward-looking statements include statements regarding the clinical attributes of UCERIS, as well as the anticipated timing for the U.S. NDA submission. 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: Santarus' ability to successfully develop its UCERIS and other product candidates in a timely manner or at all; whether Santarus is able to prepare and submit the NDA for UCERIS within its planned timeframe; whether Santarus is able to obtain regulatory approval for UCERIS and its other product candidates in a timely manner or at all, including whether the FDA agrees with the statistical analysis plan for the UCERIS Phase III studies, the clinical interpretation of the results and the conduct of the studies and whether the extended use study, which evaluated UCERIS 6 mg, will provide adequate data to support approval of UCERIS 9 mg; risks associated with the collaboration with Cosmo relating to the MMX product candidates, including the potential for termination of the collaboration; competition from other products; 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 and UCERIS^a" are trademarks of Santarus, Inc.MMX is a registered trademark of Cosmo Technologies Limited. GLUMETZA is a registered trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc.CYCLOSET is a registered trademark of VeroScience LLC.RHUCIN is a registered trademark of Pharming Group NV.Any other trademarks in this press release are the property of their respective owners.