Optimer Pharmaceuticals Announces Lower Recurrence Rates for Fidaxomicin Versus Vancocin(R) in Subgroup Analyses from Its Phase 3 Study for the Treatment of CDI

Tuesday, June 02, 2009 3:35 PM

SAN DIEGO, June 2 /PRNewswire-FirstCall/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) announced that additional results from its North American Phase 3 clinical study of fidaxomicin in patients with Clostridium difficile infection (CDI) were presented today by clinical investigator, Mark A. Miller, M.D., at the Digestive Disease Week 2009 conference in Chicago.

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The additional data presented today for the first time focused on other patient risk factors believed to be predictive of CDI recurrence following treatment. These risk factors include serum albumin levels, white blood cell (WBC) count and temperature, and non-BI (NAP1/027) strains. The data showed that fidaxomicin overall demonstrated a lower recurrence rate compared to oral vancomycin (Vancocin(R)) regardless of albumin levels, WBC count and temperature, as well as for patients with non-BI (NAP1/027) strains. Vancocin is currently the only FDA approved therapy for CDI.

Recurrence Rates by Subgroup (per protocol)

    -------------------------------------------------------------------------
    Risk Factors                         Fidaxomicin     Vancocin(R) capsules
                                         (200mg bid)         (125mg qid)
    -------------------------------------------------------------------------
    White Blood Cell Count /Temp
    -------------------------------------------------------------------------
    WBC < 15,000 uL and Temp
     < 38 degrees C                     10.7% (17/159)      22.4% (35/156)
    WBC 15-25,000 uL or Temp 38
     degrees - 39 degrees C             12.0% (3/25)        20.0% (6/30)
    WBC > 25,000 uL or Temp
     > 39 degrees C                     33.3% (1/3)         40.0% (2/5)
    -------------------------------------------------------------------------
    Albumin
    -------------------------------------------------------------------------
            < =25 mg/mL                 22.2% (8/36)        31.5% (17/54)
            26-35 mg/mL                 10.0% (9/90)        23.3% (20/86)
    -------------------------------------------------------------------------
    Strain Type
    -------------------------------------------------------------------------
        Non-BI (NAP1/027)                7.8% (8/103)       25.5% (27/106)
    -------------------------------------------------------------------------

Dr. Miller also presented the previously announced top-line results and data related to patient status (in-patient/out-patient), age (under/over 65) and the strain type BI (NAP1/027).

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