FDA Grants Fast Track Status for HCV-796 for Treatment of Hepatitis C
Virus Infection
     EXTON, Pa., June 27 /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.

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