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International, Well-Known Scientific Experts Say That New GFT505 Data Unlikely to Have the Potential to Affect the Established Role of Generic Fenofibrate and Bezafibrate in Managing Atherogenic Dyslipidemia
Date:12/16/2009

NEW YORK, December 16 /PRNewswire/ -- International, well-known scientific experts were surprised by the publication of GFT505 (80 mg/day) data presented as "extremely promising."[1] More than 50 internationally recognized expert scientists and clinicians critically reviewed these data. These experts reaffirmed the continuing role of generic lipid-modifying treatments, fenofibrate and bezafibrate, in treating atherogenic dyslipidemia, which is commonly observed in patients with metabolic syndrome and type 2 diabetes and is characterized by elevated triglycerides and low 'good' high-density lipoprotein (HDL) cholesterol. Published clinical data also already indicate a potential role for fenofibrate in treating non-alcoholic fatty liver disease.[1]

    Reviewing published evidence, these experts argued that:

    - Elevated triglycerides (>150 mg/dL) are decreased by 43% with
      generic fenofibrate[2] and 32% with generic bezafibrate[2]
    - Low HDL cholesterol (<40 mg/dL) is increased by 18%[3],[4]

Either agent is approximately two-fold more effective than 80 mg of GFT505, an investigational agent currently in early phase II development.[5]

                      GFT505     Fenofibrate        Bezafibrate

    Triglycerides      -21%     -43 percent[6]     -32 percent[7]
    (>150mg/dL)

    HDL-C (<40mg/dL)    +9%    +18,8 percent[8]   +17,9 percent[9]

Published data show a potential role for fenofibrate in treating non-alcoholic fatty liver disease, significantly decreasing the proportion of patients with liver dysfunction.[1]

Fenofibrate significantly reduced both liver enzymes, alanine amino transferase (ALT) and aspartate amino transferase (AST), unlike GFT505.[10]

Commenting on these data, these experts said: 'These new data show that GFT505 is unlikely to have the potential to replace generic fenofibrate and bezafibrate in treatin
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