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New HCV Drug- Polymerase Inhibitor

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  • Shshonee (Alley)
    doctors at natap.org doctors at natap.org Thu Jan 6 14:55:48 EST 2005 NATAP - www.natap.org New HCV Drug- Polymerase Inhibitor
    Message 1 of 1 , Jan 10, 2005
      doctors at natap.org doctors at natap.org
      Thu Jan 6 14:55:48 EST 2005

      NATAP - www.natap.org

      New HCV Drug- Polymerase Inhibitor

      ViroPharma Announces Submission of Investigational New Drug Application for

      EXTON, Pa., Jan. 6, 2005 -- ViroPharma Incorporated (Nasdaq:VPHM) today
      announced that its partner in the development of antiviral compounds targeting
      hepatitis C (HCV), Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE) has
      submitted an investigational new drug (IND) application to the U.S. Food and Drug
      Administration to evaluate ViroPharma's compound HCV-796, a novel polymerase
      inhibitor, as a potential new product to treat hepatitis C. Under this IND, a
      protocol has been prepared to assess the safety and tolerability of HCV-796 in
      healthy adult volunteers, as well as to gather pharmacokinetic data.
      Preclinical studies have shown HCV-796 may be more potent than other anti-HCV compounds
      developed to date between the two companies.

      "The filing of this IND represents an additional step in our goal to identify
      new drugs to combat hepatitis C and we are excited to kick off the
      development of this promising molecule," said Dr. Colin Broom, ViroPharma's chief
      scientific officer. "We now have two anti-HCV compounds in development. We expect to
      begin dosing patients in the HCV-796 trial later this quarter, and hope to
      initiate proof of concept studies with the compound during the second quarter of
      2005. In addition, our proof of concept trial with HCV-086 is moving forward
      expeditiously, and we continue to expect to have the data from the trial
      available later this quarter. It is our hope that we may one day offer patients
      suffering from hepatitis C an efficacious and well-tolerated option to the
      currently available therapies."

      ViroPharma and Wyeth are engaged in a collaboration to develop and commercial
      ize antiviral compounds to treat HCV.

      About hepatitis C

      Hepatitis C is a blood-borne virus recognized as a major cause of chronic
      hepatitis worldwide. The World Health Organization estimates that 170 million
      persons worldwide are chronically infected with HCV, and three to four million
      persons are newly infected globally each year. According to the U.S. Centers for
      Disease Control and Prevention (CDC), about four million people in the U.S.,
      or 1.8 percent of the population, are infected with HCV.

      About ViroPharma Incorporated

      ViroPharma Incorporated is committed to the development and commercialization
      of products that address serious diseases treated by physician specialists
      and in hospital settings. ViroPharma commercializes Vancocin(R) Pulvules(R),
      approved for oral administration for treatment of antibiotic-associated
      pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by
      Staphylococcus aureus, including methicillin-resistant strains (for prescribing
      information, please download the package insert at
      http://www.viropharma.com/Vancocin_PI.pdf). ViroPharma currently focuses its drug development activities
      in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For
      more information on ViroPharma, visit the company's website at

      Certain statements in this press release contain forward-looking statements
      that involve a number of risks and uncertainties, including those relating to
      the company's anticipated schedule relating to its HCV clinical development
      schedule as well as its ability to find an effective small molecule antiviral
      treatment for HCV disease. Our actual results could differ materially from those
      results expressed in, or implied by, these forward-looking statements.
      Conducting clinical trials for investigational pharmaceutical products is subject to
      risks and uncertainties. There can be no assurance that ViroPharma's studies
      as part of the HCV program can be conducted within the timeframe that the
      company expects, that such studies will yield positive results, or that ViroPharma
      will be successful in gaining regulatory approval of any of its HCV product
      candidates. These factors, and other factors, including, but not limited to
      those described in ViroPharma's quarterly report on Form 10-Q for the quarter
      ended September 30, 2004 filed with the Securities and Exchange Commission, could
      cause future results to differ materially from the expectations expressed in
      this press release. The forward-looking statements contained in this press
      release may become outdated over time. ViroPharma does not assume any
      responsibility for updating any forward-looking statements.

      CONTACT: ViroPharma Incorporated
      Will Roberts
      Director, Corporate Communications
      Phone (610) 321-6288

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