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Immediate-Release Formulation of Omeprazole Launched
"Zegerid Powder for Oral Suspension 20mg offers patients suffering from common gastrointestinal disorders the first once-a-day, immediate-release oral PPI formulation," said Gerald T. Proehl, president and chief executive officer of Santarus. "Our product utilizes an antacid buffer, instead of an enteric coating, to protect the omeprazole from acid degradation, allowing for rapid absorption of the omeprazole and sustained acid suppression. Mr. Proehl added, "We are optimistic about the commercial prospects for Zegerid Powder for Oral Suspension 20mg as it is being launched by an experienced sales and marketing team into a very large market that we believe to be receptive to new products." PPIs are the most frequently prescribed drugs for the treatment of many upper gastrointestinal (GI) diseases and disorders and enjoy widespread use due to their potent acid suppression, favorable safety profile and once-a-day dosing. The U.S. PPI market, including five delayed-release brands, had sales of $12.9 billion in 2003, with total U.S. prescriptions for PPIs growing 10% from 86.3 million in 2002 to 95.2 million in 2003, according to IMS Health, an independent pharmaceutical market research firm. "We have a well-defined strategic sales and marketing plan that initially targets the nation's approximately 10,000 gastroenterologists and the approximately 28,000 primary care physicians who are the highest prescribers of PPIs, a group that collectively was responsible for writing $6.1 billion of last year's PPI prescriptions," commented William C. Denby, senior vice president, commercial operations. "We have a veteran sales and marketing team leading the Zegerid launch comprised of approximately 275 people having more than 1,500 combined years of experience. The sales management team of four regional directors and 23 district managers has more than 300 combined years of GI and pharmaceutical experience. We also have an accomplished account management team responsible for private- and public-sector payors. "Following marketing approval for this product in June, we concentrated on assembling a top-quality sales force and have now hired more than 200 sales representatives. On average, these representatives have 5-1/2 years of pharmaceutical sales experience, and approximately 40% have prior experience with selling PPIs. In preparation for the Zegerid launch, we held our first-ever National Sales Meeting last week, which completed our rigorous training program that focused on product attributes as well as GI disease background and sales techniques," added Mr. Denby. Santarus has initiated shipments of Zegerid Powder for Oral Suspension 20mg to pharmaceutical wholesalers who distribute to retail pharmacies, hospitals and other institutional customers. As part of a comprehensive marketing program, Zegerid is being featured in print advertisements in leading trade publications beginning with the October issues, including the American Journal of Gastroenterology, Gastroenterology and the Journal of the American Medical Association (JAMA). The company also plans a strong presence at relevant medical conferences, including posters and symposia presentations. To complement its sales force, Santarus intends to continue to actively explore strategic collaborations for Zegerid in the U.S. and, potentially, overseas. Santarus plans to evaluate expansion of its sales force following approval of Zegerid Powder for Oral Suspension 40mg and based on market response to the Zegerid products. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, Santarus expects the FDA will complete its review or otherwise respond to the new drug application (NDA) for Zegerid Powder for Oral Suspension 40mg by December 26, 2004. The company is also developing capsule and chewable tablet formulations of Zegerid. Important Safety Information Zegerid Powder for Oral Suspension 20mg is indicated for short-term treatment of active duodenal ulcer, for heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy, and for maintenance of healing of erosive esophagitis. Controlled studies do not extend beyond 12 months. Zegerid is contraindicated in patients with known hypersensitivity to any component of the formulation. Zegerid Powder for Oral Suspension 20mg is recommended for once-daily dosing, on an empty stomach one hour prior to a meal. The most frequently reported adverse events with Zegerid are headache, diarrhea and abdominal pain. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole. Zegerid contains 460mg sodium per dose in the form of sodium bicarbonate (1680mg/20mEq), which should be taken into consideration for patients on a sodium-restricted diet. Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia.