Santarus Announces Presentation of New Open-Label UCERIS (Budesonide) Data at the Crohn's and Colitis Foundation Clinical & Research Conference

Update: Uceris (budesonide) Now FDA Approved - January 14, 2013

SAN DIEGO--(BUSINESS WIRE)--Dec 1, 2011 - Santarus, Inc. (NASDAQ: SNTS) today announced that new data from a clinical study to assess the efficacy and safety of eight weeks of open-label treatment with the investigational drug UCERIS (budesonide) 9 mg Tablets in patients with mild or moderate active ulcerative colitis will be available in poster sessions on December 2–3, 2011 at the Crohn's & Colitis Foundation's Clinical & Research Conference, 2011 Advances in Inflammatory Bowel Diseases being held in Hollywood, Florida. The poster is titled Induction of Remission with Oral Budesonide MMX® (9 mg) Tablets in Patients with Active, Mild to Moderate Ulcerative Colitis: A Multicenter, Open-Label Efficacy and Safety Study (Travis, et al). The clinical study enrolled patients who failed to achieve clinical and endoscopic remission in a previous pivotal Phase III eight week induction study after receiving treatment in one of four treatment groups: UCERIS 9 mg, UCERIS 6 mg, Asacol® (mesalamine) 2400 mg, or placebo.

In the 60 patients enrolled in the UCERIS 9 mg open-label study, the overall rate of remission was 25.0%; clinical improvement was 26.7%; endoscopic improvement was 40.0%; and symptom resolution was 33.3%. Safety data from the open-label UCERIS 9 mg clinical study indicated that overall frequencies of treatment emergent adverse events occurred to a similar extent regardless of which prior treatment group (UCERIS 9 mg, UCERIS 6 mg, Asacol 2400 mg, or placebo) the patient was in during the previous eight week pivotal Phase III clinical study. The most commonly reported treatment emergent adverse events were decreases in blood cortisol, urinary tract infection, and Cushingoid. Potential glucocorticoid-related effects and treatment-related adverse events were infrequent. Mean morning plasma cortisol levels were within normal limits (138 to 690 nmol/L) at baseline and at the final visit regardless of prior therapy (228.1 nmol/L and 167.4 nmol/L, respectively).

“This open-label data will be included in an integrated summary of safety and efficacy in the new drug application (NDA) for UCERIS 9 mg for the induction of remission of mild or moderate active ulcerative colitis,” said E. David Ballard, M.D., senior vice president of medical affairs and pharmacovigilance at Santarus. “We are on track to submit the UCERIS NDA to the FDA later this month.”

Open-Label Study Design

The open-label clinical study with UCERIS was conducted in collaboration with Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals S.p.A., as a companion study to a pivotal Phase III clinical study in patients with mild or moderate active ulcerative colitis. Patients from the Phase III placebo-controlled clinical study who completed eight weeks of induction therapy in any treatment group (UCERIS 9 mg, UCERIS 6 mg, Asacol 2400 mg, or placebo) and who were not in remission were eligible to enroll in the companion study to receive an additional eight weeks of open-label treatment with UCERIS 9 mg.

The primary endpoint was induction of clinical and endoscopic remission, defined by an Ulcerative Colitis Disease Activity Index (UCDAI) score of ‰¤ 1 after eight weeks, with scores of 0 for rectal bleeding and stool frequency, no mucosal friability after colonoscopy, and ‰¥ 1 point reduction from baseline in the endoscopic index score. Clinical improvement (‰¥ 3 point reduction in UCDAI), endoscopic improvement (‰¥ 1 point reduction in the UCDAI mucosal appearance subscore) and symptom resolution (score of 0 for rectal bleeding and stool frequency from the UCDAI score) were also evaluated at the end of the treatment.

About UCERIS (budesonide) Tablets

UCERIS (budesonide) Tablets 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 Crohn's & 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 company's 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 (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 travelers' 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 the clinical data from the open-label study or other studies conducted for UCERIS will support regulatory approval of UCERIS; 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 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.

Contact: Company Contact:
Martha L. Hough
VP Finance & Investor Relations
(858) 314-5824
or
Debra P. Crawford
Chief Financial Officer
(858) 314-5708
or
Investor Contact:
LHA
Jody Cain (jcain@lhai.com)
Bruce Voss (bvoss@lhai.com)
(310) 691-7100

 

Posted: December 2011

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