ViroPharma's New Drug Application for Picovir -pleconaril- Filed -Accepted for Review- by the U.S. Food and Drug Administration.Business Editors EXTON, Pa.--(BUSINESS WIRE)--Oct. 1, 2001 ViroPharma Incorporated (Nasdaq: VPHM) today announced that its New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for Picovir(TM) (pleconaril) has been filed (accepted for review) by the U.S. Food and Drug Administration. ViroPharma submitted its NDA on July 31, 2001 for Picovir(TM) for clearance to market the product candidate for the treatment of viral respiratory infection (VRI VRI Vacation Register International VRI Video Relay Interpreting VRI Vehicle Research Institute (Western Washington University, Bellingham, Washington) VRI Venture Research Institute (Lake Forest, California) , otherwise known as the common cold) in adults. Picovir(TM) is a first-of-a-kind oral antiviral product that specifically inhibits the function of the picornavirus picornavirus Any of a group of the smallest known animal viruses. (Pico refers to their small size, rna to their core of RNA.) This group of spheroidal viruses includes viruses that attack the vertebrate intestinal tract and often invade the central nervous system as well capsid capsid /cap·sid/ (kap´sid) the shell of protein that protects the nucleic acid of a virus; it is composed of structural units, or capsomers. cap·sid n. , a protective shell of the virus that is essential for virus infectivity and transmission. Picornaviruses are the primary cause of VRI. ViroPharma and Aventis Pharmaceuticals, the U.S. pharmaceutical company of Aventis Pharma AG, recently formed a collaboration to co-develop and co-promote ViroPharma's Picovir(TM) (pleconaril) in the United States. Additional Pleconaril Trials Ongoing ViroPharma and Aventis currently are conducting additional studies with Picovir(TM) for the treatment of pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. VRI, as well as to explore the potential for use in preventing VRI. To date, more than 4,000 patients have been treated with pleconaril in ViroPharma-sponsored clinical trials. Picovir(TM) was well tolerated, with a side effect profile similar to placebo. ViroPharma and Aventis also make Picovir(TM) available in a compassionate use compassionate use Pharmacology The use of an agent to treat Pts for whom conventional therapies have failed, or for whom no other drug exists; CU refers to the use of an agent on humanitarian grounds before it has received regulatory–FDA–approval program to patients with serious or life-threatening picornavirus infections, such as neonatal enteroviral sepsis, acute viral myocarditis Myocarditis Definition Myocarditis is an inflammatory disease of the heart muscle (myocardium) that can result from a variety of causes. While most cases are produced by a viral infection, an inflammation of the heart muscle may also be instigated by and chronic enteroviral meningoencephalitis meningoencephalitis /me·nin·go·en·ceph·a·li·tis/ (me-ning?go-en-sef?ah-li´tis) inflammation of the brain and meninges. toxoplasmic meningoencephalitis . Viral Respiratory Infection: Need for Treatment Viral respiratory infection is an acute upper respiratory tract viral infection that causes inflammation of the mucous membranes lining the nose and throat. Symptoms of VRI include nasal discharge (rhinorrhea), nasal obstruction and congestion The condition of a network when there is not enough bandwidth to support the current traffic load. congestion - When the offered load of a data communication path exceeds the capacity. , sneezing To verbally tell somebody about a new and interesting Web site. See viral marketing. , sore or "scratchy" throat, cough and shortness of breath Shortness of Breath Definition Shortness of breath, or dyspnea, is a feeling of difficult or labored breathing that is out of proportion to the patient's level of physical activity. . According to the National Institutes of Health, there are approximately 1 billion colds annually in the United States. Currently, 52 million physician visits are attributable to patients with VRI, yet there are no antiviral treatments available for these patients. Patients often take a variety of prescription or over-the-counter medications for VRI, however these medications do not treat the underlying cause of the disease, the virus. About ViroPharma Incorporated ViroPharma Incorporated is committed to the commercialization, development and discovery of antiviral pharmaceuticals. The company is focused on drug development and discovery activities in viral diseases including viral respiratory infection (VRI), hepatitis C and RSV RSV respiratory syncytial virus; Rous sarcoma virus. RSV abbr. respiratory syncytial virus RSV 1 Respiratory syncytial virus, see there 2 Rous sarcoma virus, see there disease. ViroPharma's most advanced product candidate, Picovir(TM) (pleconaril), is in clinical development for treatment of picornavirus diseases. ViroPharma also has product candidates in clinical development for the treatment of hepatitis C and RSV disease. About Aventis Aventis Pharmaceuticals conducts the U.S. business of Aventis Pharma AG. 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. (NYSE NYSE See: New York Stock Exchange :AVE). 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 King of Prussia, industrialized suburban area (1990 pop. 18,406), Montgomery co., SE Pa. It has glass and steel fabricating, food processing, printing and publishing, and varied manufacturing (textiles, liquified petroleum gas, water-treatment and electrical , 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 statements relating to ViroPharma's efforts to obtain regulatory approval to market Picovir, to commercialize Picovir(TM), and to ViroPharma's and Aventis' plans for additional clinical trials of Picovir(TM). Neither the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. nor any other regulatory authority has approved Picovir(TM) for commercialization. There can be no assurance that FDA or other regulatory authority approval for Picovir(TM) will be granted on a timely basis or at all. Even if approved, there can be no assurance that Picovir(TM) will achieve market acceptance. With regard to ViroPharma's and Aventis' plans for additional clinical trials, investors should note that the conduct of clinical trials and acquiring regulatory approval for investigational pharmaceutical products are subject to risks and uncertainties. There can be no assurance that planned clinical trials can be initiated, or that that planned or ongoing clinical trials can be successfully concluded or concluded in accordance with ViroPharma's and Aventis' anticipated schedule. 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 report, including the press release attached hereto, 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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called 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. |
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