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FW: NATAP: Schering HCV Protease Inhibitor-FDA Fast Tracks

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  • alleypat
    Schering-Plough HCV Protease Inhibitor: FDA Grants Fast Track Schering Plough released this press announcement today. SCHERING-PLOUGH REPORTS FDA GRANTS FAST
    Message 1 of 1 , Jan 31, 2006
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      Schering-Plough HCV Protease Inhibitor: FDA Grants Fast Track

      Schering Plough released this press announcement today.

      SCHERING-PLOUGH REPORTS FDA GRANTS FAST TRACK DESIGNATION TO ORAL HCV
      PROTEASE INHIBITOR SCH 503034

      KENILWORTH, N.J., Jan. 30, 2006 - Schering-Plough today reported that the
      U.S. Food and Drug Administration (FDA) has granted Fast Track designation
      to its investigational oral hepatitis C protease inhibitor (SCH 503034),
      currently in Phase II clinical development for the treatment of chronic
      hepatitis C virus (HCV) infection.

      The FDA granted Fast Track designation for the following reasons:
      o The proposed first indication for SCH 503034 is for treatment of HCV
      in patients with HCV genotype 1 virus who have not responded to combination
      therapy with pegylated interferon and ribavirin, the current standard of
      care, thus representing an unmet medical need.
      o SCH 503034 is an orally active inhibitor of the hepatitis C virus
      serine protease that inhibits HCV replication. This mechanism is distinct
      from those of current therapies, thus SCH 503034 represents a novel class of
      HCV inhibitor.

      Fast Track designation allows FDA to expedite review of drugs and biologics
      for serious or life-threatening conditions and which demonstrate the
      potential to address unmet medical needs. An important feature of Fast
      Track designation is that it emphasizes the critical nature of close, early
      communication between the FDA and the sponsor company to improve the
      efficiency of product development.

      Here are links to first report of study data in patients reported at AASLD
      Nov 2005:

      SCH 503034 HCV Protease Inhibitor Monotherapy in HCV Genotype 1 IFN
      Nonresponders (11/15/05)

      Combination therapy with SCH-503034 HCV Protease Inhibitor & PegIntron in
      Non-Responders: phase !b study results (11/15/05

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