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Title: FDA Approves Nexium (Esomeprazole Magnesium) For Gastroesophageal Reflux Disease

"FDA Approves Nexium (Esomeprazole Magnesium) For Gastroesophageal Reflux Disease"

WILMINGTON, DE -- February 21, 2001 -- With more than 21 million Americans believed to suffer from gastroesophageal reflux disease (GERD) , characterized by frequent and persistent heartburn, new Nexium™ (esomeprazole magnesium) may represent an important treatment alternative. Nexium will be available by prescription in March. AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved Nexium, a proton pump inhibitor, for heartburn and other symptoms associated with gastroesophageal reflux disease (GERD) and for the healing of erosive esophagitis, a potentially serious condition associated with GERD. The FDA also approved Nexium for maintenance of healing of erosive esophagitis and, in combination with amoxicillin and clarithromycin for eradication of Helicobacter pylori infection in patients with duodenal ulcer disease. "There are millions of patients who suffer needlessly from GERD symptoms, the most common of which is frequent and persistent heartburn," said Peter Kahrilas, M.D., chief, Division of Gastroenterology and Hepatology, Northwestern University Medical School and the principal investigator of a large clinical study involving the drug. "Nexium can provide patients with relief from their chronic heartburn symptoms, while healing damage to the esophagus. I'm particularly encouraged by the clinical studies that indicate nearly nine out of 10 patients with erosive esophagitis were healed when treated with this drug for eight weeks." AstraZeneca, the maker of Prilosec® (omeprazole), developed Nexium as an optical isomer, the first proton pump inhibitor (PPI) to be developed in this way. Nexium is derived from Prilosec, which is a mixture of two molecules with identical molecular structure but different 3-dimensional orientations in space - that is the two molecules are mirror images of each other. Nexium is one of these two molecules. Both Nexium, a new prescription product, and Prilosec block the final step of acid production in the stomach by inhibiting the acid-producing cells known as parietal cells. Prilosec, the first and most prescribed PPI on the market, has been available in the U.S. since 1989. The total dollar value in 2000 of the U.S. PPI market was an estimated $8.3 billion. The wholesaler acquisition cost (WAC) for Nexium is $3.33/capsule for either a Nexium 20 mg or 40 mg capsule. The WAC is the catalog price at which AstraZeneca sells Nexium capsules to wholesalers. The actual acquisition cost for individual pharmacies and patients may vary. Nexium 40 mg or 20 mg is indicated for the short-term (4 to 8-weeks) treatment of diagnosed erosive esophagitis (EE). The healing rates of Nexium 40 mg and Nexium 20 mg were evaluated against Prilosec 20 mg (the approved dose for acid-related diseases) in patients with diagnosed EE in four multi-center, double-blind, randomized studies. Nexium is the first PPI to be approved by the FDA, using another PPI as an active control in its pivotal, clinical trials. Results from these trials showed that Nexium 40 mg and 20 mg provided excellent healing rates (89.9 percent to 94.1 percent) and resolution of heartburn symptoms in erosive esophagitis patients. In clinical trials, the safety profile of Nexium was similar to that of Prilosec. While Nexium is generally well tolerated, it is not for everybody. The most frequently occurring side effects were headache (5.5 for Nexium 20 mg, 5.0 for Nexium 40 mg, and 3.8 for Prilosec 20 mg) and diarrhea. Nausea, flatulence, abdominal pain, constipation and dry mouth occurred at similar rates among patients taking Nexium or Prilosec. Related Link: [AstraZeneca.

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