“These favorable Phase III results in travelers’ diarrhea represent a significant positive milestone in the clinical development of rifamycin SV MMX for the U.S. market. Rifamycin SV is an investigational broad spectrum, non-systemic antibiotic that has been used for more than 20 years in Europe in both intravenous and intramuscular forms, but is considered a new chemical entity in the U.S.,” said Wendell Wierenga, Ph.D., executive vice president, research and development of Santarus. “As we wait for completion of the second ongoing Phase III study being conducted by Dr. Falk Pharma, we plan to assess our options to evaluate rifamycin SV MMX in other indications where a non-systemic antibiotic with a broad spectrum of activity may offer a clinical benefit.”About the Rifamycin SV MMX Phase III Clinical Study The Phase III clinical study enrolled 264 patients, 65 patients on placebo and 199 patients on rifamycin SV MMX, in an international multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of rifamycin SV MMX. The dosing regimen was 400 mg (two oral tablets of 200 mg each) taken twice daily (800 mg total daily dose) of rifamycin SV MMX or placebo for three days in the treatment of patients with travelers’ diarrhea. The primary endpoint of TLUS was defined as the time (hours) between the administration of the first dose of study drug and the time that the last unformed stool was passed before the start of clinical cure. Clinical cure was defined in the study protocol as:
- The passage of two or fewer soft stools and no watery stools, no fever (>100.4°F or 38°C), and no symptoms of enteric infection (other than mild excess gas/flatulence) during a 24-hour interval in the 120-hour data collection period after the first dose of study drug; or
- The passage of no stools or only formed stools and no fever during a 48-hour interval in the 120-hour data collection period after the first dose of study drug, with or without other signs of symptoms of enteric infection.
Travelers’ Diarrhea/Intestinal InfectionsIntestinal infections are caused by bacteria, viruses or parasites. A common infection of the intestine is travelers’ diarrhea, which is primarily caused by the ingestion of food or water contaminated by pathogenic strains of bacteria. According to the U.S. Centers for Disease Control and Prevention, each year between 20% and 50% of international travelers (an estimated 10 million people) develop diarrhea, primarily caused by bacteria. 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, and on FENOGLIDE® (fenofibrate) tablets, which is indicated as an adjunct to diet to reduce high cholesterol. Santarus has a diverse product development pipeline. A New Drug Application for UCERIS ™ (budesonide) tablets for induction of remission of active, mild to moderate ulcerative colitis is under review by the U.S. Food and Drug Administration with a response expected in January 2013. The pipeline also includes two late-stage investigational drugs in Phase III clinical studies: RUCONEST ® (recombinant human C1 esterase inhibitor) for treatment of acute attacks of hereditary angioedema and rifamycin SV MMX ® for treatment of travelers’ diarrhea. In addition, the company’s investigational monoclonal antibody, SAN-300, is being evaluated in a Phase I clinical program. 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. For example, statements regarding the timing of the Dr. Falk Phase III clinical study of rifamycin SV MMX, the potential for ultimate FDA approval and anticipated patent protection are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans 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 rifamycin SV MMX in a timely manner or at all; whether the Dr. Falk Phase III clinical study is completed in a timely and successful manner; whether Santarus is able to obtain regulatory approval for rifamycin SV MMX in a timely manner or at all, including whether the FDA agrees with the clinical interpretation of the results and the conduct of the studies; risks associated with the license agreement with Cosmo relating to rifamycin SV MMX, including the potential for termination of the agreement; competition from other products; unexpected adverse side effects or inadequate therapeutic efficacy; the scope and validity of patent protection for rifamycin SV MMX; other difficulties or delays in development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus’ products; 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 ® , FENOGLIDE ® and UCERIS ™ 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.