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New HCV Drug- Polymerase Inhibitor
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ViroPharma Announces Submission of Investigational New Drug Application for HCV-796
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 commercialize 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 www.viropharma.com
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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