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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

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]

    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 treating patients with atherogenic dyslipidemia.'


    [1] Fernández-Miranda C, Pérez-Carreras M, Colina F, López-Alonso G,
        Vargas C, Solís-Herruzo JA. A pilot trial of fenofibrate for the
        treatment of non-alcoholic fatty liver disease. Dig Liver Dis
    [2] Ruotolo G, Ericsson CG, Tettamanti C, Karpe F, Grip L, Svane B,
        Nilsson J, de Faire U, Hamsten A. Treatment effects on serum
        lipoprotein lipids, apolipoproteins and low density lipoprotein
        particle size and relationships of lipoprotein variables to
        progression of coronary artery disease in the Bezafibrate Coronary
        Atherosclerosis Intervention Trial (BECAIT). J Am Coll Cardiol
    [3] Farnier M, Freeman MW, Macdonell G, Perevozskaya I, Davies MJ,
        Mitchel YB, Gumbiner B; Ezetimibe Study Group. Efficacy and safety
        of the coadministration of ezetimibe with fenofibrate in patients
        with mixed hyperlipidaemia Eur Heart J 2005;26:897.
    [4] The BIP Study Group. Secondary prevention by raising HDL cholesterol
        and reducing triglycerides in patients with coronary artery disease:
        the Bezafibrate Infarction Prevention (BIP) study. Circulation
    [5] Press release. GENFIT: Extremely promising GFT505 results in
        Phase II.
        PR_GENFIT_GFT505_Results.pdf. [Accessed 4 Dec 2009].
    [6] Farnier et al, Eu Heart J. 2005,26:897
    [7] Ruotulo et al, JACC Vol 32, b 6 November 15 1998:1648-56
    [8] Farnier et al, Eu Heart J, 2005, 26:897
    [9] The BIO Study Group, Circulation, Volume 102(1)4 July 2000pp 21-27
    [10] Press release. GENFIT: A new potential indication for GFT505,
         diabetes associated fatty liver disease.

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SOURCE international experts

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