Rifamycin SV MMX is a broad spectrum, semi-synthetic antibiotic with negligible systemic absorption that also has targeted release characteristics when taken orally. The application of MMX technology to rifamycin SV allows the antibiotic to be delivered directly to the colon, optimizing drug levels in the colon where the pathogens of travelers ™ diarrhea are predominant. In addition to the targeted drug delivery, the company believes the negligible absorption of rifamycin SV MMX will offer an opportunity for limited side effects.

Cosmo ™s European partner, Dr. Falk Pharma GmbH, is planning to initiate in the first half of 2010 a Phase III clinical study in patients with travelers ™ diarrhea for registration of rifamycin SV MMX in the European Union (EU). The Dr. Falk Phase III study will assess the efficacy (non-inferiority) and safety of rifamycin SV MMX 400 mg (2 x 200 mg) oral tablets taken twice daily (800 mg total daily dose) for three days versus ciprofloxacin 500 mg tablets twice daily (1,000 mg total daily dose) in the treatment of patients with travelers ™ diarrhea. Assuming successful completion of the Phase III clinical program, Santarus and Dr. Falk plan to share their clinical data for inclusion in each company ™s respective regulatory submissions.

Source Santarus, Inc.