Monday December 17, 1:00 am Eastern Time
Press Release
SOURCE: Aventis Pharmaceuticals and ViroPharma Incorporated
ViroPharma to Join Aventis Pharmaceuticals in Promoting Allegra(R) (fexofenadine HCI) and Nasacort(R)AQ (triamcinolone acetonide)
EXTON, Pa., and BRIDGEWATER, N.J., Dec. 17 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM - news) and Aventis Pharmaceuticals, the U.S. pharmaceutical company of Aventis Pharma AG, today announced that the ViroPharma sales force will join Aventis to promote products from the Allegra® family and Nasacort® AQ to primary care physicians throughout the United States beginning January 2002.
(Logo: newscom.com )
In September 2001, Aventis and ViroPharma signed an agreement involving the co-development and co-promotion of Picovir(TM) (pleconaril) in the United States. As part of that agreement, ViroPharma will receive detailing fees from Aventis for calls promoting these two products from Aventis' respiratory franchise. If Picovir(TM) is approved, then the ViroPharma sales force will co-promote Picovir, as well as one of Aventis' products.
By promoting two of Aventis' top products, ViroPharma expects that its sales force will leverage the respiratory expertise and experience of the Aventis sales force, and ViroPharma will begin to establish itself in the primary care marketplace, an important customer base for the launch of Picovir(TM). Also, ViroPharma should substantially defray its sales promotion costs while promoting Aventis' products. Since the agreement was executed, ViroPharma has been hiring the initial segment of its sales force and building the infrastructure required to support that organization. As a result, ViroPharma expects to incur significant sales and marketing expenses in the fourth quarter of this year, including one-time start-up costs and other initial nonreimbursed investments.
About Allegra® (fexofenadine HCl)
Allegra is the world's fastest growing prescription medicine for seasonal allergy symptoms and chronic idiopathic urticaria (hives). It is a powerful, safe and effective nonsedating antihistamine. With more than 2.8 billion combined patient days of therapy:
* Once-daily Allegra 180 mg tablets offer a full 24-hours of relief of
seasonal allergy symptoms for people 12 years and older;
* Twice-daily Allegra-D (fexofenadine HCl 60 mg/pseudoephedrine HCl
120 mg) extended-release tablets provide safe and effective relief of
seasonal allergy symptoms, including nasal congestion, at 60 minutes*
for patients 12 years and older;
* Twice-daily Allegra 60 mg tablets give patients another dosage option
for seasonal allergies and provide relief of chronic idiopathic
urticaria (hives) for people 12 years and older; and
* Twice-daily Allegra 30 mg tablets provide relief of seasonal allergies
and chronic idiopathic urticaria (hives) in children ages 6 to
11 years.
The most commonly reported adverse events with Allegra 180mg and placebo in seasonal allergic rhinitis patients 12 and older are headache (10.6% vs. 7.5%), upper respiratory tract infection (3.2% vs. 3.1%), and back pain (2.8% vs. 1.4%). The most commonly reported adverse events with Allegra 60mg bid and placebo for seasonal allergic rhinitis patients 12 and older are viral infection (cold, flu) (2.5% vs 1.5%), nausea (1.6% vs 1.5%), and dysmenorrhea (1.5% vs 0.3%). The most commonly reported adverse events with Allegra 60mg bid and placebo in chronic idiopathic urticaria patients 12 and older are back pain (2.2% vs 1.1%), sinusitis (2.2% vs 1.1%), dizziness (2.2% vs 0.6%), and drowsiness (2.2% vs. 0.0%). The most commonly reported adverse events with Allegra 30mg and placebo in seasonal allergic rhinitis patients 6-11 years are headache (7.2% vs 6.6%), upper respiratory tract infection (4.3% vs 1.7%), coughing (3.8% vs 1.3%), and accidental injury (2.9% vs 1.3%).
Due to pseudoephedrine, Allegra-D is contraindicated in patients with narrow-angle glaucoma or urinary retention, in patients receiving monoamine oxidase MAO inhibitor therapy or within 14 days of stopping such treatment, and in patients with severe hypertension or severe coronary artery disease. Allegra-D should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment or prostatic hypertrophy. Care should be taken in the administration of Allegra-D concomitantly with other sympathomimetic amines because combined effects on the cardiovascular system may be harmful to the patient. The most commonly reported adverse events for Allegra-D compared to fexofenadine HCI alone are headache (13.0% vs. 11.5%), insomnia (12.6% vs. 3.2%), and nausea (7.4% vs. 0.5%).
Single dose studied in an environmental exposure unit (EEU), an enriched pollen environment in an artificial study setting.
About Nasacort® AQ (triamcinolone acetonide)
Nasacort AQ is a once-daily corticosteroid nasal spray for the treatment of the nasal symptoms associated with seasonal and year-round allergies in adults and children six years of age and older. Nasacort AQ nasal spray has no fragrance, is not bad tasting and contains no irritating alcohol.
Additionally, in a survey of 9,337 patients who tried Nasacort AQ, nine out of ten said they would ask for it again.
The most commonly reported side effects with Nasacort AQ nasal spray were similar to placebo. In adults and children ages 12 and older, they were: pharyngitis (5.1% vs. 3.6%), epistaxis (2.7% vs. 0.8%), and increase in cough (2.1% vs. 1.5%). In studies including children ages six to 11, they were: pharyngitis (7.4% vs. 6.4%) and increase in cough (7.0% vs. 6.4%).
About Picovir(TM)
Picovir(TM) is a first-of-a-kind oral antiviral product currently under review by the U.S. Food and Drug Administration for the treatment of viral respiratory infection (VRI, otherwise known as the common cold) in adults. The compound is licensed by ViroPharma from Sanofi-Synthelabo for the United States and Canada.
About Aventis Pharmaceuticals
Aventis Pharmaceuticals conducts the U.S. business of Aventis Pharma AG (NYSE: AVE - news). 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 SA, a world leader in pharmaceuticals and agriculture, is headquartered in Strasbourg, France. In 2000, Aventis generated group sales of Euro 22.3 billion ($20.6 billion) and employed around 92,500 people. The company announced in November 2000 that it intends to focus on pharmaceuticals and plans to divest it activities in agriculture. Aventis was launched in December 1999 through the merger of Hoechst AG of Germany and Rhone-Poulenc SA of France. For more information, please visit: aventis.com.
Full prescribing information is available by visiting the Aventis Pharmaceuticals U.S. Web site at aventispharma-us.com. Also available at this U.S. Web site are copies of this release or any recent release, or call 800-207-8049.
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(TM), is in clinical development for the treatment of picornavirus diseases, and is the subject of a new drug application (NDA) that has been accepted for review 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.
This press release contains forward-looking statements, including statements relating to ViroPharma's efforts to obtain regulatory approval to market Picovir(TM), ViroPharma's efforts to commercialize Picovir(TM), ViroPharma's ability to use the copromotion of Aventis Products to establish ViroPharma in the primary care marketplace, and its expected increases in expenses. Neither the FDA 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. There can be no assurance that ViroPharma's actual expenses will reflect the level of expenses anticipated by ViroPharma. These factors, and other factors that could cause future results to differ materially from the expectations expressed in this report, including the press release attached hereto, 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, 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.
SOURCE: Aventis Pharmaceuticals and ViroPharma Incorporated |
