EXTON, Pa. and BRIDGEWATER, N.J., Feb. 6, 2002 -- ViroPharma Incorporated (Nasdaq:VPHM) and Aventis Pharmaceuticals, the U.S. pharmaceutical company of Aventis Pharma AG, today announced that the new drug application for Picovir™ (pleconaril), an investigational product being developed for the treatment of viral respiratory infection (VRI, or the common cold) in adults, is scheduled to be reviewed by the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) on March 19, 2002.
ViroPharma submitted the new drug application (NDA) for marketing approval of Picovir™ to the FDA in July 2001. In late September 2001, ViroPharma was notified that the Picovir™ NDA submission was accepted for filing. Also in September, ViroPharma and Aventis signed an agreement to co-develop and co-promote Picovir™ in the United States.
About ViroPharma Incorporated
ViroPharma Incorporated is committed to the commercialization, development and discovery of antiviral pharmaceuticals. ViroPharma is focused on drug development and discovery activities in viral diseases including viral respiratory infection (VRI), hepatitis C and RSV disease.
ViroPharma's most advanced product candidate, Picovir™, is in clinical development for the treatment of picornavirus diseases, and is the subject of a new drug application (NDA) that is being reviewed by the U.S. Food and Drug Administration for the treatment of VRI in adults.
ViroPharma also has product candidates in preclinical and clinical development for the treatment of hepatitis C and RSV diseases.
About Aventis Pharmaceuticals
Aventis Pharmaceuticals conducts the U.S. business of Aventis Pharma AG (NYSE:AVE). With headquarters in Bridgewater, N.J., Aventis Pharmaceuticals focuses its activities on important therapeutic areas such as cardiology, oncology, anti-infectives, arthritis, allergy and respiratory, diabetes, and the central nervous system.
Aventis Pharma AG is the pharmaceutical company of Aventis S.A. Aventis Pharma is dedicated to treating and preventing human disease through the discovery, development, manufacture and sale of innovative pharmaceutical products aimed at fulfilling unmet medical needs. The corporate headquarters of Aventis Pharma is in Frankfurt, Germany.
Aventis Pharma is comprised of Aventis Pharmaceuticals; Aventis Pasteur, a world leader in vaccines, headquartered in Lyon, France; and Aventis Behring, a world leader in therapeutic proteins, headquartered in King of Prussia, Pa.
Aventis S.A., a world leader in pharmaceuticals and agriculture, is headquartered in Strasbourg, France. The company employs approximately 92,500 people in more than 120 countries. Aventis was launched in December 1999 through the merger of Hoechst AG and Rhone-Poulenc S.A.
To receive a copy of this release or any recent release, visit the Aventis Pharmaceuticals U.S. Web site at http://www.aventispharma-us.com or call 800/207-8049.
This press release contains forward-looking statements, including statements relating to ViroPharma's efforts to obtain regulatory approval to market Picovir™. There can be no assurance that FDA or other regulatory authority approval for Picovir™ will be granted on a timely basis or at all. Even if approved, there can be no assurance that Picovir™ will achieve market acceptance.
These factors, and other factors that could cause future results to differ materially from the expectations expressed in this press release, include, but are not limited to, those described in ViroPharma's most recent Registration Statement on Form S-3 filed with the Securities and Exchange Commission.
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.
Statements in this news release other than historical information are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation, and the effectiveness of patent protection.
Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission.