Santarus Reports Positive Phase III Results from Diarrhea Drug

After the markets’ close Tuesday, Santarus Inc. (NASDAQ:SNTS) reported top-line data from a phase III trial of rifamycin SV MMX, sending shares up 6% in early trading Wednesday. The drug is a treatment for traveler’s diarrhea and showed an improvement in Time to Last Unformed Stool (TLUS), the trial’s primary endpoint. The drug showed very few adverse effects in the trials. The compound has been in use for more than 20 years in the EU according to SNTS, but is considered a new chemical entity in the U.S. Don’t expect a quick move towards a New Drug Application as Santarus plans to wait for phase III data from its European licensing partner Dr. Falk Pharma, which is expected in mid-2013. The companies plan to share data before proceeding with the regulatory approval process in their respective geographical regions. Rifamycin SV MMX is licensed from Cosmo Technologies, which is in turn partnered with Dr. Falk Pharma in the EU. The European clinical study pits rifamycin SV MMX against ciprofloxacin in order to prove non-inferiority of the new drug. The study will enroll roughly 1000 patients and should be revealing of the drug’s potential in the marketplace. Shares of SNTS should remain strong today as the treatment is one of Santarus’ lead candidates – along with Ruconest – that has yet to file for approval.