Additional Data From Fidaxomicin's Phase 3 Study for Clostridium Difficile Infection (CDI) Presented at IDSA Annu... ((72% vs. 50% p0.022) lower CDI recurrenc...)

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Additional Data From Fidaxomicin's Phase 3 Study for Clostridium Difficile Infection (CDI) Presented at IDSA Annual Meeting

Date:10/31/2009

(72% vs. 50%, p=0.022), lower CDI recurrence rate (40% vs. 23%, p=0.061), and higher clinical cure rate (87% vs. 77%, p=0.171).

"The faster time to resolution of diarrhea and improved outcomes for patients requiring concomitant antibiotics are important factors for physicians to consider when selecting a treatment for CDI," said Michael N. Chang, Ph.D., President and CEO of Optimer Pharmaceuticals. "These additional factors along with the significantly lower recurrence rate and higher global cure rate suggest that fidaxomicin has the potential to be a best in class therapy for CDI."

For a complete list of posters, please visit the Resources webpage on our web site at www.optimerpharma.com.

Fidaxomicin Clinical Study Design

629 adult subjects were enrolled in this multi-center, randomized, double-blind phase 3 clinical trial, which was the largest such trial for the treatment of CDI. Subjects with confirmed CDI received either 200 mg fidaxomicin dosed orally twice daily or 125 mg Vancocin dosed orally four times daily. This study was conducted in more than 100 clinical sites throughout North America. The objective of the study was to show that a 10-day course of fidaxomicin was at least as efficacious (non-inferior) and safe as a 10-day course of Vancocin (vancomycin hydrochloride capsules, USP) for the treatment of CDI.

The primary endpoint of the study was clinical cure defined as patients requiring no further CDI therapy two days after completion of study medication, as determined by the investigator. The secondary endpoint evaluated CDI recurrence up to four weeks post therapy with recurrence defined as the return of diarrhea associated with CDI confirmed by a positive toxin test. Global cure was defined as patients who were cured and did not have a recurrence.

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Additional Data From Fidaxomicin's Phase 3 Study for Clostridium Difficile Infection (CDI) Presented at IDSA Annu...((72% vs. 50% p0.022) lower CDI recurrenc...)