FDA Grants Fast Track Status for HCV-796 for Treatment of Hepatitis C Virus Infection
EXTON, Pa., June 27, 2007 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for HCV-796 for treatment of hepatitis C virus infection. HCV-796, a unique orally dosed non nucleoside hepatitis C viral polymerase inhibitor that interferes with the replication of hepatitis C virus (HCV), is currently undergoing Phase 2 evaluation and is being co-developed with Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE).
Under the FDA Modernization Act of 1997, fast track designation may potentially expedite the review of a drug that is intended for the treatment of a serious life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition. Fast track designation allows the FDA to accept, on a rolling basis, portions of a marketing application for review prior to the completion of the final registration package. However, the designation does not guarantee approval or expedited approval of any application for the product.
"The receipt of fast track designation for HCV-796 is an important regulatory step forward as we continue to work closely with the FDA and our Wyeth colleagues throughout the development process," commented Robert Pietrusko, Pharm.D, ViroPharma's vice president of global regulatory affairs and quality.
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 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.
Currently, there is no specific antiviral agent directed against HCV that is commercially available, and no vaccine for prevention of HCV infection. Several interferon products are available worldwide, but there are substantial limitations to the use of these products when given as monotherapy or in conjunction with ribavirin in the treatment of chronic HCV infection. In addition to the relatively poor treatment response in patients infected with genotype 1 HCV, the most common strain in the U.S., Western Europe and Japan, the considerable side effects frequently associated with the use of interferon can lead to discontinuation of therapy in approximately 20 percent of patients.
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) 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. 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 http://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 progress of its HCV clinical development program. 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 additional HCV studies will yield positive results, that the FDA or other regulatory authorities will not require additional or unanticipated studies or clinical trial outcomes before granting regulatory approval, 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 March 31, 2007 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.
SOURCE ViroPharma Incorporated
/CONTACT: William C. Roberts, Senior Director, Corporate Communications,
+1-610-321-6288, or Robert A. Doody, Manager, Corporate Communications,
+1-610-321-6290, both of ViroPharma Incorporated/
/Web site: http://www.viropharma.com/
Posted: June 2007
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