To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Protonix (Pantoprazole) Available in US for Short-Term Treatment Of Erosive Esophagitis URL: http://www.pslgroup.com/dg/1D25AE.htm Doctor's Guide May 18, 2000
MADISON, NJ -- May 18, 2000 -- American Home Products Corporation announced that Protonix(r) (pantoprazole sodium), the newest of the popular proton pump inhibitors (PPI) to be approved by the U.S. Food and Drug Administration (FDA) for the short-term treatment of erosive esophagitis, is now available in pharmacies. Protonix is priced significantly less than other PPIs now available for this indication, up to 28 percent less, or up to $1.00 less per day, which may be a benefit to patients. This price discount is based on a comparison of the catalog price for Protonix versus the catalog price for other marketed PPIs. Protonix 40 mg delayed-release tablets are approved for short-term (up to 16 weeks) healing and symptomatic relief of erosive esophagitis (EE) associated with gastroesophageal reflux disease (GERD). The new product is marketed by Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corporation. Erosive esophagitis is one of the more serious forms of GERD, a condition caused by the reflux (reverse flow) of stomach acid into the esophagus. More than 40 percent of adults - nearly 60 million Americans - experience symptoms of GERD (typically a burning pain behind the breastbone) two or more times per week, and nearly half of all GERD sufferers have esophageal erosions which are indicative of erosive GERD. If left untreated or uncontrolled, esophageal damage caused by GERD can lead to more serious complications, including stricture, hemorrhage, a pre-cancerous condition known as Barrett's esophagus, and esophageal cancer. "Erosive esophagitis associated with reflux disease and its complications cause significant morbidity in the U.S.," said Joel E. Richter, MD, past president of the American College of Gastroenterology and professor of medicine and chief of the GI department at The Cleveland Clinic Foundation. "PPIs are the most effective treatment now available, but they are costly. Protonix should provide an attractive alternative for some erosive GERD patients." Pantoprazole was evaluated in more than 100 clinical trials worldwide, involving more than 45,000 patients. In U.S. studies, Protonix has been shown to provide complete elimination of nighttime heartburn and regurgitation. Physicians have determined that nighttime GERD symptoms may be associated with more serious esophageal damage. Protonix has no known clinically significant drug interactions, and no dose adjustments should be required for elderly, renally impaired, or mildly to moderately hepatically impaired patients. In U.S. clinical trials, the most frequently reported side effects in Protonix patients, headache and diarrhea, occurred in about the same rates as placebo and nizatidine 150 mg bid (Axid(R)). Symptomatic response to therapy does not preclude the presence of gastric malignancy. Protonix is contraindicated in patients with known hypersensitivity to any component of the formulation. Protonix is indicated for use for up to 16 weeks. Please see full prescribing information. Protonix represents a major new product opportunity and the foundation for a new therapeutic franchise for Wyeth-Ayerst Laboratories in the rapidly growing $7.5 billion gastrointestinal market. The PPI market segment has grown at an average of more than 40 percent in prescription volume since 1994, and it is projected that the total prescription GI market will exceed $8.6 billion by the end of this year. Pantoprazole currently is available in over 60 countries and was first launched outside the US in 1994 by Byk Gulden of Konstanz, Germany, developers of the compound. To date, pantoprazole has been prescribed to more than 27 million patients around the world. Wyeth-Ayerst Laboratories, a division of American Home Products Corporation, is a major research-oriented pharmaceutical company with leading products in the areas of women's health care, cardiovascular disease therapies, central nervous system drugs, anti-inflammatory agents, vaccines, and generic pharmaceuticals. American Home Products is one of the world's largest research-based pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of prescription drugs and over-the-counter medications. It also is a leader in vaccines, biotechnology, and animal health care. Related Links: Protonix (pantoprazole sodium), Wyeth-Ayerst Laboratories and American Home Products Corporation. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. 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