Santarus Announces Oral Presentations of Budesonide MMX Phase III Data at Digestive Disease Week Meeting
SAN DIEGO--(BUSINESS WIRE)--May 3, 2011 - Santarus, Inc. (NASDAQ: SNTS) today announced that the budesonide MMX® Phase III clinical program will be featured in two oral presentations at the Digestive Disease Week (DDW) Meeting being held at McCormick Place in Chicago on May 7–10, 2011.
The oral presentations are scheduled as follows:
Presenter: Simon Travis, DPhil, FRCP, Saturday, May 7, 2011 at 4:45 p.m. CT
- Oral presentation #S100AB in the Research Forum – Controlled Clinical Trials in Inflammatory Bowel Disease (IBD), Budesonide MMX® 9 mg for induction of remission of mild-to-moderate ulcerative colitis: data from a multicenter, randomized, double-blind, placebo-controlled study in Europe, Russia, Israel and Australia
Presenter: William J. Sandborn, M.D., Monday, May 9, 2011 at 3:00 p.m. CT
- Oral presentation #S403 in the Topic Forum – What's New in IBD, Budesonide MMX® 9 mg for the induction of remission of mild-to-moderate ulcerative colitis: data from a multicenter, randomized, double-blind, placebo-controlled study in North America and India
Santarus plans to file the presentation slides in a Form 8-K filing with the Securities and Exchange (SEC) on Monday, May 9, 2011.
About Budesonide MMX
Budesonide MMX 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 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.
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. DDW is jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in gastrointestinal research, medicine and technology. For more information, visit www.ddw.org.
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 with three late-stage product candidates in Phase III clinical programs: budesonide MMX® 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 on the company's website 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: 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 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® is a registered trademark 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: Santarus, Inc.
Martha L. Hough, VP Finance & Investor Relations
Debra P. Crawford, Chief Financial Officer
Lippert/Heilshorn & Associates, Inc.
Jody Cain, 310-691-7100
Bruce Voss, 310-691-7100
Posted: May 2011