Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, today announced that is has begun to enroll patients in the first study in its Phase III clinical program to evaluate the efficacy and safety of rifamycin SV MMX ® for the treatment of patients with travelers’ diarrhea. “The Ministries of Health in Mexico and Guatemala have approved our clinical trial applications for the Phase III study with rifamycin SV MMX, and we are beginning to enroll patients at clinical sites in these countries,” said E. David Ballard, M.D., senior vice president, clinical research and medical affairs of Santarus. “Our plan for patient enrollment is to coincide with the peak summer travel season.” He added, “Rifamycin SV has been used for more than 20 years in Europe in both intravenous and intramuscular dosage forms and has had a good safety profile. Rifamycin SV has also demonstrated a broad spectrum of in vitro activity targeted to the main enteropathogens that cause travelers’ diarrhea.” The principal investigator for the Phase III clinical study is Herbert L. DuPont, M.D., Director of the Center for Infectious Diseases and Professor of Epidemiology at the University of Texas – Houston School of Public Health, Chief of Internal Medicine at St. Luke’s Hospital and Vice Chairman, Department of Medicine and Clinical Professor at the Baylor College of Medicine. Dr. DuPont is a recognized expert in public health and infectious diseases with an emphasis on travelers’ diarrhea. In the Phase III clinical program, Santarus plans to undertake two international multicenter, randomized, double-blind studies, each with up to approximately 300 patients, to assess the efficacy and safety of rifamycin SV MMX 400 mg (2 times 200 mg) oral tablets taken twice daily (800 mg total daily dose) for three days versus placebo in the treatment of patients with travelers’ diarrhea. The primary endpoint of the Phase III clinical studies will be the time to last unformed stool (TLUS) and the studies will seek to demonstrate the superiority of rifamycin SV MMX to placebo.
Rifamycin SV MMX is a broad spectrum, semi-synthetic antibiotic with negligible systemic absorption, which is being developed for the treatment of patients with travelers’ diarrhea and potentially for other diseases that have an infectious component in the colon. Due to the negligible systemic absorption of rifamycin SV, the company believes that rifamycin SV MMX will offer an opportunity for limited side effects and will be less prone to the development of antibiotic-resistant strains of bacteria, a major concern with systemically delivered antibiotics.Travelers’ Diarrhea/Intestinal Infections Intestinal 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 (or an estimated 10 million people) develop diarrhea, with approximately 80% of the cases caused by bacteria. MMX Technology The MMX technology consists of a sequence of lipophilic and amphiphilic matrices dispersed within a hydrophilic matrix. MMX tablets are coated with gastro-resistant polymers that protect the active pharmaceutical ingredient (API) against degradation in the upper gastrointestinal tract and delay the release of the API until the tablet reaches the colon. The MMX technology as applied to rifamycin SV MMX is covered by an issued U.S. patent that expires in 2020, and an additional patent application is pending at the U.S. Patent and Trademark Office. 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 gastroenterologists, endocrinologists and other physicians. The company’s current commercial efforts are focused on ZEGERID ® (omeprazole/sodium bicarbonate), which is indicated for the treatment of certain upper GI diseases and disorders, and on GLUMETZA ® (metformin hydrochloride extended release tablets), which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Santarus is also developing two late-stage lower GI product candidates, budesonide MMX ® and rifamycin SV MMX ®, for the U.S. market. Budesonide MMX is being investigated in a Phase III clinical program for the induction of remission of mild or moderate active ulcerative colitis. Santarus began Phase III clinical testing of rifamycin SV MMX in patients with travelers’ diarrhea in the second quarter of 2010. More information about Santarus is available on the company’s Web site 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 potential attributes of rifamycin SV MMX and the timing of the Phase III clinical program for rifamycin SV MMX. 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: whether rifamycin SV MMX will demonstrate the desired safety and efficacy profile; whether the rifamycin SV MMX Phase III clinical program will be successful and initiated and completed in a timely manner; 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 ® and ZEGERID ® are registered trademarks of Santarus, Inc. GLUMETZA ® is a registered trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. MMX ® is a registered trademark of Cosmo Technologies Limited.